Promoting Child Development at Sick-Child Visits: A Controlled Trial
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ABSTRACT
OBJECTIVE. In developing countries, the health care system often is the only existing infrastructure that can reach young children, and health care encounters may be the only opportunity for professionals to have a positive influence on child development. To address the discrepancy between Western and developing countries related to the information that is available for caregivers on how to support their child's development, the World Health Organization Department of Child and Adolescent Health and Development and United Nations International Children's Education Fund have developed the Care for Development Intervention. The Care for Development Intervention aims during acute health visits to enhance caregivers' play and communication with their children. For facilitation of its delivery worldwide, the Care for Development Intervention was developed as an additional module of the Integrated Management of Childhood Illness training course. The purpose of this study was to determine the efficacy and the safety of the Care for Development Intervention when implemented during a young child's visit for acute minor illness.
METHODS. The study design is a sequentially conducted controlled trial, with the comparison arm completed first, Care for Development Intervention training provided for the clinicians next, followed by the intervention arm. At the Pediatric Department of Ankara University School of Medicine, 2 pediatricians who were blinded to the study aims and hypotheses before Care for Development Intervention training provided standard health care to the comparison group; they then received Care for Development Intervention training and provided standard health care plus the Care for Development Intervention to the intervention group. Compliance with treatment and the outcome of illness were determined by a follow-up examination in the clinic 1 week later. One month after the clinic visits, an adapted Home Observation for Measurement of the Environment was administered in the homes by researchers who were blinded to study aims and hypotheses.
RESULTS. Children who were aged 24 months and attended the clinic with minor or no illnesses were recruited for the study: 113 in the comparison group and 120 in the intervention group. At the 1-month home visit, significantly more families had optimal Home Observation for Measurement of the Environment scores (17.5% vs 6.2%), more homemade toys were observed (42.5% vs 10.6%), and more caregivers reported reading to their children (20.0% vs 3.5%) in the intervention than in the comparison group. Three independent predictors of optimal Home Observation for Measurement of the Environment score emerged from the logistic regression analysis: being in the intervention group, child ages >6 months, and maternal education greater than secondary school. Compliance with medical treatment and illness outcomes were not significantly different between the 2 groups.
CONCLUSIONS. The Care for Development Intervention is an effective method of supporting caregivers' efforts to provide a more stimulating environment for their children and can be used by health care professionals during visits for acute minor illness.
Key Words: child development ? developing country
Abbreviations: WHO—World Health Organization ? UNICEF—United Nations International Children's Education Fund ? CDI—Care for Development Intervention ? IMCI—Integrated Management of Childhood Illness ? HOME—Home Observation for Measurement of the Environment Inventory ? RR—relative risk ? CI—confidence interval
The United Nations Convention on the Rights of the Child calls for countries to help children develop to their utmost potential. International organizations, such as the World Health Organization (WHO) and the United Nations International Children’s Education Fund (UNICEF), recognize that health systems no longer can aim just for child survival but also must address child development.1–3 As information on brain development in early childhood and its effects on health and development across the life span have increased,4,5 developed countries have been redefining health care for children to address a broad range of psychosocial and developmental issues.6–11 In many developing countries, infancy and young childhood are considered passive periods during which the child is nursed and fed without much communication or play, and this lack of stimulation is a key element in developmental delay.2,12 The health care system is the only existing infrastructure that can reach young children, and health care encounters may be the only opportunity for professionals in developing countries to have a positive influence on the development of the young child.12,13
Socioeconomic difficulties and the paucity of simple models of interventions that can reach large populations have been major barriers to promoting child development. Furthermore, in developing countries, children have few encounters with health care providers, and typically these are not for well-child visits but for acute illnesses. To address the discrepancy between Western and developing countries related to the information that is available for caregivers on how to support their child’s development, the WHO Department of Child and Adolescent Health and Development and UNICEF have developed the Care for Development Intervention (CDI).14 The CDI aims to provide a cost-effective approach to enhancing the development of young children across public health care settings with resource limitations and is designed to be used when any child who is 2 years of age is seen for a health care visit. After the reason for the visit is addressed, the health care provider conducts a standardized interview to assess how the caregiver plays and communicates with the child. The intervention includes strategies for listening and observing for positive interactions, using specific praise and positive reinforcement, and providing the caregiver with ideas on play and homemade toys for age-appropriate stimulation. The CDI is well informed from current theories of child development and places caregiver-child interactions and the stimulation of the young child at the core of enhancing child development.15
Child development is a complex construct, and the early intervention literature suggests that sustained and comprehensive approaches have an impact.16 The justification for brief interventions such as the CDI have evolved from the substantial information on the importance of incorporating a developmental approach into health care delivery for young children.2–10,17–20 It has been shown that caregivers identify a strong desire and need to talk about child development with their health care provider,21 and caregivers who receive during health care encounters interventions about playing and interacting with their children can benefit.22 More recently, a focused intervention, Reach Out and Read, has been shown to be beneficial.23,24
For facilitation of its delivery, the CDI was developed as an additional module of the Integrated Management of Childhood Illness (IMCI)25 training course, which already has been delivered in >100 countries. Pilot studies in Brazil (I. Santos, MD, PhD, H. Goncalves, PhD, R. Halpern, PhD, C. Victora, MD, PhD, Pilot Test of the Child Development of the IMCI "Counsel the Mother" Module: Study Results and Recommendations, unpublished report, 1999) and South Africa (M. Chopra, Assessment of Participants on the Care for Development IMCI Training Course, unpublished report, 2001) suggest that CDI training improves the counseling skills of health care providers. Questions that remain unanswered are whether caregivers remember the CDI recommendations and apply them in the home and whether the CDI is "safe" to use during visits for an acute minor illness. Therefore, the purpose of this study was to determine the efficacy and the safety of the CDI when implemented during a young child’s visit for acute minor illness. We hypothesized that (1) caregivers who received the intervention would have more materials for stimulation and enhanced communication in their homes than a comparison group of caregivers who received standard care and (2) the addition of the CDI to sick-child visits would not decrease a caregiver’s compliance with treatment recommendations and there would not be a negative impact on the outcome of the illness.
METHODS
Study Design
The study design is a sequentially conducted controlled trial, with the comparison arm completed first, CDI training provided for the clinicians next, followed by the intervention arm. A randomized, controlled trial was not applied because it was considered important that both arms of the study be conducted by the same clinicians and that previous training in the CDI should not influence the standard care provided in the comparison arm of the study. One pediatrician (G.A.) was responsible for recruitment of participants. Two pediatricians (D.G.D. and B.E.B.) who had equal training and experience and were blinded to study aims and hypotheses before training for the CDI were instructed to provide routine care to patients in the comparison group. Subsequently, after CDI training, they were asked to apply the CDI to all of the patients in the intervention group. Six researchers who were experienced in child development and blinded to the aims and hypotheses of the study collected observational and interview information. Participants were informed that this was a study on child health and development and that there would be 2 groups receiving similar health care and 1 group given additional information. All participants provided written informed consent before enrollment. The study was approved by Ankara University Medical School Ethics Committee and the WHO Ethics Review Committee.
Setting and Participants
The study was conducted between March and June 2004 at the pediatric department outpatient clinic at Ankara University School of Medicine. This clinic provides services for children who come from low to middle socioeconomic backgrounds in Ankara, the capital city with a population of 4.5 million. Children were recruited when they were 24 months of age or younger and came to the clinic with a minor illness or well-child care and mothers were present during the clinic visit and were the primary caregivers in the home. Children who were clinically judged to be moderate to severely ill and those who lived outside Ankara were excluded.
Measures and Procedures
The measures (Table 1) were selected and developed after a comprehensive review of previously used and validated instruments. Researchers obtained 90% interobserver agreement on the instruments before the trial. One pediatrician (G.A.) screened all families who came to the clinic for eligibility criteria, obtained written consent, and used the Acute Illness Observation Scale26 to ensure eligibility. Children then were assigned in alternating order to 1 of 2 pediatricians (D.G.D. and B.E.B.), who provided routine pediatric care. The visit was observed by a researcher who used the Physician Counseling Skills Scale27 (I. Santos, MD, PhD, H. Goncalves, PhD, R. Halpern, PhD, C. Victora, MD, PhD, Pilot Test of the Child Development of the IMCI "Counsel the Mother" Module: Study Results and Recommendations, unpublished report, 1999) to assess the physician's competence in counseling caregivers on the child's health and development. At the end of each visit, the physician completed a structured form that included the child's diagnosis and the treatment recommendations. When the physician left the room, caregivers completed the Satisfaction with Physician Scale.28 Participants returned for a follow-up visit 1 week later, and at that visit, the same pediatrician who initially had seen the child examined the child for remaining symptoms of the illness and recorded on a structured form the outcome of the child's illness, any additional visits to other clinics, admissions to a hospital, and use of medication and other treatment modalities. Outcome of illness and compliance with treatment were determined by a separate review and coding of these records by 2 physicians who were blinded to group status. "Total compliance" was scored when the caregivers stated using all of the medications that were recommended by the pediatrician in the correct dosage and frequency. One month later, a second researcher, who had not met the family before and who was blind to the hypothesis and the aims of the study, conducted a home visit and administered the adapted Home Observation for Measurement of the Environment Inventory (HOME).29,30
When all of the clinic visits for the comparison group were completed, the 2 pediatricians participated in training and piloting of the CDI, after which the intervention group was enrolled. All measures and procedures were identical for the intervention group except for the addition of the CDI to each visit. After routine procedures, the pediatrician conducted the standard CDI interview14 to assess how the caregiver played and communicated with the child in the home. The physicians listened for and observed positive caregiver-child interactions, used specific praise and positive reinforcement throughout the visit, and showed the caregiver examples of play and homemade toys for increased caregiver-child communication and age-appropriate stimulation. One extra recommendation that was based on the Reach Out and Read program, which was developed and promoted in the United States,23,24 reading picture books to young children, also was included in the intervention. At the 1-week follow-up visit for the intervention group, pediatricians reinforced the CDI by praising the caregiver on added stimulation materials and communication to the child's environment; when the caregiver had not applied the recommendations, the reasons were sought and the importance of enhancing the child's environment was reiterated.
The main hypothesis of the study, that the intervention group would have more play and communication in the home than the control group, was assessed using the HOME. Although the HOME has not been standardized for children in Turkey or other developing countries, because of its ability to measure universally recognized nurturing and stimulating qualities in a child's environment, its excellent psychometric properties, and ability to predict later development, the HOME has been used in many developing countries.31–34 For this study, 5 experts in child development reviewed the HOME items and concluded that all items were culturally relevant and that 26 items could measure all of the goals of the CDI. The remaining 19 items were included to allow for comparisons of total scores with previous studies. The adaptation involved expanding items on toys to include homemade play materials in their appropriate categories. For example, if the caregiver provided clothespins for the child to place in a plastic bottle, then this play material was scored on the HOME scale as an eye-hand coordination toy.
Statistical Analysis
The main outcome was amount of stimulation provided to the child in the home (as observed by the adapted HOME scale) 1 month after the clinic visit. Sample size estimates were based on the potential to increase the proportion of participants with HOME scores 38 (a score that is predictive of optimal developmental outcome23) from 40% in the comparison group to 60% in the intervention group, with = .05 (2-tailed test) and power set at 1 – ? = .80. Allowing for 20% attrition, the minimum required enrollment was 128 per group. Statistical significance of differences between groups was examined using the 2 test and relative risks (RR) for categorical data and Mann Whitney U test for continuous data that are not normally distributed. In a logistic regression model, we examined the independent effects on optimal (38) HOME scores of child and caregiver characteristics that have been identified to affect home environments. These variables included group status, gender of child, age of child (<6 vs 6 months), having siblings, maternal and paternal education of secondary school or less (at most 8 years) versus high school or more education, nuclear (parents and children) versus traditional (extended family) family, housing situation (shanty houses versus apartment housing), insurance status (poverty insurance or none versus employment insurance), and maternal report of depressed mood. For all analyses, SPSS 11.5 was used.35
RESULTS
Of the 263 families approached, only 4 declined to participate and a total of 259 children were enrolled in the study: 129 and 130 in the comparison and intervention groups, respectively. The reasons and final diagnoses given for the visits included acute upper respiratory tract infection (36.9%), well-child care (18.0%), newborn problems (12.4%), dermatitis (8.6%), and other minor problems. As none of the families identified a primary health care provider, for all children in the study, this pediatric care included management of presenting illness as well as provision of preventive health care, such as immunizations and counseling for nutrition and safety. The mean duration of the initial visits were 25.6 minutes (SD: 6.1) in the comparison group and 36.9 minutes (SD: 10.5) in the intervention group (P < .01). The 1-week clinic visit and the 1-month home visit were complete for 233 children, 113 (87.6%) and 120 (92.3%) in the comparison and intervention groups, respectively. Families' visits outside Ankara and family illness that prevented appointments were the major reasons for loss to follow-up. There were no significant differences in severity of illness (as measured by the Acute Illness Observation Scale) or any of the baseline sociodemographic characteristics between those who completed the study and the 26 who were lost to follow-up. The results pertain to the 233 families with complete follow-up. As seen in Table 2, there were no significant differences between the intervention and comparison groups on any of the sociodemographic variables. Most children were 12 months or younger, were the only children in the homes, and had mothers and fathers with at most high school education.
At the 1-month home visit, 95.0% and 13.3% of caregivers in the intervention and comparison groups, respectively, stated that the pediatrician provided information on promoting their child's development. As seen in Table 3, in the intervention group, more caregivers themselves or other family members had tried a new play activity with the child in the past month than in the comparison group. Significant differences were not found between the intervention and comparison groups on the total score of the HOME (median: 31.5 and 31.0, respectively; P = .262), but the proportion of HOME scores 38 were significantly higher in the intervention than comparison group. Scores of items on subscales that pertained to the caregiver's communication with the child ("responsivity of the caregiver," "acceptance of child by caregiver," and "caregiver involvement with child") were not significantly different between the 2 groups. In contrast, items on subscales "learning materials and toys provided to child" and "opportunities for variety in daily stimulation" accounted for the differences. As seen in Table 3, in the past month, more families in the intervention group had made at least 1 toy for their child and reported reading to their children at least twice a week than in the comparison group. Three independent predictors of optimal HOME score emerged from the logistic regression analysis: being in the intervention group (adjusted RR: 3.2; 95% confidence interval [CI]: 1.2–8.3), child age >6 months (adjusted RR: 7.7; 95% CI: 2.5–23.7), and maternal education greater than secondary school (adjusted RR: 5.5; 95% CI: 1.8–17.1).
At the 1-week follow-up visit, of the 191 (82.0%) children with minor illness, 78.8% (78) and 72.8% (67) of children in the intervention and comparison groups, respectively, were determined by caregiver history and pediatricians' examinations to have recovered from the initial illness (RR: 0.9; 95% CI: 0.8–1.1). The total number of families who had taken their children for a second visit to a health center for the presenting illness was 33 (17.3%), with no significant group difference in distribution. Of the 180 children who were prescribed medications, 78 (87.6%) of 89 and 70 (76.9%) of 91 (RR: 0.9%; 95% CI: 0.8–1.0) caregivers in the intervention and comparison groups, respectively, totally complied with treatment. Unwarranted medications, such as antibiotics that were not recommended by the pediatricians, were used by 16.5% (15) of caregivers in the comparison group versus 7.9% (7) of caregivers in the intervention group (RR: 2.1%; 95% CI: 0.9–4.9).
After the CDI training, physicians were observed to use 2 counseling skills more frequently: encouraging the caregiver to talk (observed in 45.1% and 99.2% of the visits before and after CDI training, respectively; P < .001) and encouraging the caregiver to ask questions (observed in 42.5% and 85.8% of the visits before and after CDI training, respectively; P < .001). The median total scores on the Satisfaction with Physician Scale were 60 (range: 40–60) in the intervention group compared with 59 (range: 37–60) in the comparison group (P < .001).
DISCUSSION
This study is the first to use a controlled trial to test the efficacy and the safety of the CDI, a new intervention that is to be promoted by the WHO and UNICEF. We have shown that delivering of CDI messages during acute health care visits by trained physicians resulted in more optimal stimulation in the home environments of the intervention group than in a comparable group of young children who were seen by the same physicians before their CDI training. Being in the intervention group remained a significant predictor of optimal home scores when we controlled for other caregiver and child characteristics.
The few controlled trials that have examined the effects of addressing child development during routine health care encounters have been conducted in Western populations and during visits for well-child care, when parents are more likely to be more receptive to receiving information.6,22 The question that was addressed for the first time in this study was whether the CDI intervention is efficacious when delivered during 1 acute visit and its follow-up to caregivers who likely are concerned with the physical health of their child and who have no previous relationship with the health provider. This is the prevalent scenario in developing countries where children rarely receive continuous well-child care. The CDI adds 10 minutes to a health care encounter; this is comparable to other interventions that involve counseling, such as those that promote breastfeeding, optimal nutrition, or home safety. The concrete outcome of this brief intervention, that caregivers in the intervention group were 4 times more likely to make toys for their young children than those in the control group, has important implications. It indicates that caregivers not only comprehended the importance of stimulation for their child's development but also put thought, time, effort, and creativity into provide this stimulus. This study also has shown that messages other than those that are present in the generic CDI can be added to the intervention. A simple 1-time recommendation about reading to young children that is based on the intensive Reach Out and Read model resulted in salient benefits. We speculate that the success of these brief interventions in engaging caregivers is attributable to the trust in the importance of information that is received from health care providers, the novelty and the attraction of learning how to help children develop, the concreteness and simplicity of the recommendations, and the joyful response that these interventions elicit from the children.
Although the majority of families reported remembering the intervention and messages, not all families were shown to act on these messages. To eliminate the Hawthorne effect, the HOME scale was applied once, after the intervention. We cannot examine, therefore, whether families with lower baseline HOME scores benefited more from the intervention. Higher maternal education and older age of child predicted optimal HOME scores independent of the intervention. Maternal education is widely known as a significant predictor of child health and development. Our findings emphasize the importance of the education of women in promoting the development of their children. The results also suggest that special attention should be given to youngest infants, who may be of highest risk for understimulation. Caregiver-child communication, a major focus of the CDI, was not significantly different between the intervention and comparison groups in this study. In this sample, in which caregiver responsivity and communication already were high, we may not have used sensitive measures to observe this effect. It also is possible that caregiver communication, being a complex construct,3 requires more intensive interventions than the CDI, which is applied on few occasions. Studies in South Africa and Brazil have demonstrated that interventions with greater intensity than the CDI (1 involving 22 hour-long sessions36 and the other involving a 50-minute training session postpartum37) had a positive effect on mother-child communicative interactions. Future studies are needed to investigate ways in which the CDI can be intensified to have a larger impact, particularly on caregiver-child communicative interactions, and to provide a precise measurement of this impact.
This study provides reassurance for plans to incorporate the CDI with the IMCI. The addition of the CDI to sick-child visits did not adversely affect the outcome of the acute illnesses or the caregivers' compliance with treatment. Because this was a study of efficacy that was conducted under controlled conditions and because of the limitations of obtaining information on compliance with treatment from parents, we recommend that this important question be investigated further in future studies of effectiveness. The benefits of linking the CDI to the IMCI are obvious. The IMCI targets infants and young children, who often are brought for nutritional counseling or acute illness. These same children most likely will benefit from messages on child development. The CDI when linked to IMCI therefore should cover children who are in most need. The strategy of using health care visits to monitor child development long has been recognized.38,39 Linking of the CDI to the IMCI broadens this strategy by using the opportunity of the health visit for minor illness to promote development.
Previous studies have shown that CDI training increases the counseling skills of health care providers (I. Santos, MD, PhD, H. Goncalves, PhD, R. Halpern, PhD, C. Victora, MD, PhD, Pilot Test of the Child Development of the IMCI "Counsel the Mother" Module: Study Results and Recommendations, unpublished report, 1999; M. Chopra, MD, PhD, Assessment of Participants on the Care for Development IMCI Training Course, unpublished report, 2001). In this study, key elements of counseling—encouraging caregivers to talk and ask questions—were significantly enhanced with CDI training. Caregivers' satisfaction with physicians was high in both groups and although reaching a statistically significant difference, was not meaningfully different between the 2 groups. We have anecdotal evidence that the physicians felt more confident in their relationship with caregivers after they received the CDI training, and more caregivers in the intervention group remarked on the physicians' positive attitude 1 month after the contact. Future studies are needed to determine whether the CDI has a positive impact on caregiver-health care provider relationships and the use of health care services. The CDI would provide a more comprehensive approach to child development if it also could be linked to a system that determines a community's opportunities and priorities on child development and that has professionals trained in identifying and treating children with developmental delays and providing in-depth counseling that is specific to the child's and the family's needs.
The generalizability of this study sample is limited; it is representative of low- to middle-income children who lived in Ankara and whose mothers were not working outside the home. Children in this sample seem to be at low risk for poor developmental outcomes: they were well nourished and cared for, the families were intact, and the fathers were employed. The mean adapted HOME scores, however, were comparable to high-risk samples in Western countries. In a study in the United States of children who were 2 years of age and at risk for being removed from their families as a result of abuse or neglect, the mean HOME score was 31.7 (SD: 6.0) compared with 30.4 (SD: 6.1) in our study.40 Factors that are associated with risk and resilience in home environments differ between populations and need to be identified to guide interventions.15 In our study, despite high scores on caregiver responsivity and involvement, stimulation for young children was suboptimal.
The long-term effects on child development of such a brief intervention as the CDI are unknown. The WHO justifies the dissemination of this intervention on the basis of the widely known long-term benefits to child development of optimal stimulation during early childhood and the child rights initiative that calls for the "state-of-the-art" information on child health and development to be delivered rapidly for the benefit of all children across the world. The demonstration in this study of the efficacy of this brief intervention and its safety during sick-child visits suggests that the CDI can be recommended globally to be used during health care delivery. Future studies of the effectiveness of the CDI are needed to determine whether it can be applied and sustained for large populations in clinical practice and to determine the long-term effects of this intervention on the caregiving environment of children and on health care provider-caregiver relationships.
CONCLUSIONS
Developing countries are not benefiting from the state-of-the-art of health and early childhood programs in developed nations.12,41–43 The feasibility of the CDI, the brevity of the training for any health professional, and the CDI's ease of application during acute visits make the CDI a unique intervention with the potential of having an impact on child development, particularly throughout the developing world. Its rapid dissemination is needed to begin decreasing the discrepancies between developed and developing countries with regard to the promotion of child development.
ACKNOWLEDGMENTS
This study was funded by a grant from the Department of Child and Adolescent Health and Development of the World Health Organization (project ID: 03011 HNI).
We thank Drs Jose Martines, Jane Lucas, Meena Cabral, Patrice Engle, and Linda Richter for invaluable contributions to the CDI. We express gratitude to Drs Paul McCarthy, Bettye Caldwell, and Patrick Casey for generous permission to use their instruments; Drs John Leventhal, Brian Forsyth, Eugene Shapiro, and Frank Oberklaid for critique of the study design, analysis, and interpretation of the data; and Derya ?ztuna for help with the statistical analysis. We thank the families for volunteering; Canan Gül G?k, Hanife Gülnur ?zdemir, Gülden ?ztürk, G?nül Erdoan, and Habibe Dilsiz for contributions to the collection of the data; and Nermin Sezer for secretarial support.
FOOTNOTES
Accepted Feb 6, 2006.
Address correspondence to Ilgi Ozturk Ertem, MD, Ankara University School of Medicine, Department of Pediatrics, Developmental-Behavioral Pediatrics Unit, Cebeci, Ankara 06100, Turkey. E-mail: ertemilgi@yahoo.com
The authors have indicated they have no financial relationships relevant to this article to disclose.
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Bhutta ZA, Darmstadt GL, Hasan BS, Haws RA. Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence. Pediatrics. 2005;115 (suppl):519 –617
Developmental-Behavioral Pediatrics Unit, Department of Pediatrics, Ankara University School of Medicine, Ankara, Turkey(Ilgi Ozturk Ertem, MD, Gu)
OBJECTIVE. In developing countries, the health care system often is the only existing infrastructure that can reach young children, and health care encounters may be the only opportunity for professionals to have a positive influence on child development. To address the discrepancy between Western and developing countries related to the information that is available for caregivers on how to support their child's development, the World Health Organization Department of Child and Adolescent Health and Development and United Nations International Children's Education Fund have developed the Care for Development Intervention. The Care for Development Intervention aims during acute health visits to enhance caregivers' play and communication with their children. For facilitation of its delivery worldwide, the Care for Development Intervention was developed as an additional module of the Integrated Management of Childhood Illness training course. The purpose of this study was to determine the efficacy and the safety of the Care for Development Intervention when implemented during a young child's visit for acute minor illness.
METHODS. The study design is a sequentially conducted controlled trial, with the comparison arm completed first, Care for Development Intervention training provided for the clinicians next, followed by the intervention arm. At the Pediatric Department of Ankara University School of Medicine, 2 pediatricians who were blinded to the study aims and hypotheses before Care for Development Intervention training provided standard health care to the comparison group; they then received Care for Development Intervention training and provided standard health care plus the Care for Development Intervention to the intervention group. Compliance with treatment and the outcome of illness were determined by a follow-up examination in the clinic 1 week later. One month after the clinic visits, an adapted Home Observation for Measurement of the Environment was administered in the homes by researchers who were blinded to study aims and hypotheses.
RESULTS. Children who were aged 24 months and attended the clinic with minor or no illnesses were recruited for the study: 113 in the comparison group and 120 in the intervention group. At the 1-month home visit, significantly more families had optimal Home Observation for Measurement of the Environment scores (17.5% vs 6.2%), more homemade toys were observed (42.5% vs 10.6%), and more caregivers reported reading to their children (20.0% vs 3.5%) in the intervention than in the comparison group. Three independent predictors of optimal Home Observation for Measurement of the Environment score emerged from the logistic regression analysis: being in the intervention group, child ages >6 months, and maternal education greater than secondary school. Compliance with medical treatment and illness outcomes were not significantly different between the 2 groups.
CONCLUSIONS. The Care for Development Intervention is an effective method of supporting caregivers' efforts to provide a more stimulating environment for their children and can be used by health care professionals during visits for acute minor illness.
Key Words: child development ? developing country
Abbreviations: WHO—World Health Organization ? UNICEF—United Nations International Children's Education Fund ? CDI—Care for Development Intervention ? IMCI—Integrated Management of Childhood Illness ? HOME—Home Observation for Measurement of the Environment Inventory ? RR—relative risk ? CI—confidence interval
The United Nations Convention on the Rights of the Child calls for countries to help children develop to their utmost potential. International organizations, such as the World Health Organization (WHO) and the United Nations International Children’s Education Fund (UNICEF), recognize that health systems no longer can aim just for child survival but also must address child development.1–3 As information on brain development in early childhood and its effects on health and development across the life span have increased,4,5 developed countries have been redefining health care for children to address a broad range of psychosocial and developmental issues.6–11 In many developing countries, infancy and young childhood are considered passive periods during which the child is nursed and fed without much communication or play, and this lack of stimulation is a key element in developmental delay.2,12 The health care system is the only existing infrastructure that can reach young children, and health care encounters may be the only opportunity for professionals in developing countries to have a positive influence on the development of the young child.12,13
Socioeconomic difficulties and the paucity of simple models of interventions that can reach large populations have been major barriers to promoting child development. Furthermore, in developing countries, children have few encounters with health care providers, and typically these are not for well-child visits but for acute illnesses. To address the discrepancy between Western and developing countries related to the information that is available for caregivers on how to support their child’s development, the WHO Department of Child and Adolescent Health and Development and UNICEF have developed the Care for Development Intervention (CDI).14 The CDI aims to provide a cost-effective approach to enhancing the development of young children across public health care settings with resource limitations and is designed to be used when any child who is 2 years of age is seen for a health care visit. After the reason for the visit is addressed, the health care provider conducts a standardized interview to assess how the caregiver plays and communicates with the child. The intervention includes strategies for listening and observing for positive interactions, using specific praise and positive reinforcement, and providing the caregiver with ideas on play and homemade toys for age-appropriate stimulation. The CDI is well informed from current theories of child development and places caregiver-child interactions and the stimulation of the young child at the core of enhancing child development.15
Child development is a complex construct, and the early intervention literature suggests that sustained and comprehensive approaches have an impact.16 The justification for brief interventions such as the CDI have evolved from the substantial information on the importance of incorporating a developmental approach into health care delivery for young children.2–10,17–20 It has been shown that caregivers identify a strong desire and need to talk about child development with their health care provider,21 and caregivers who receive during health care encounters interventions about playing and interacting with their children can benefit.22 More recently, a focused intervention, Reach Out and Read, has been shown to be beneficial.23,24
For facilitation of its delivery, the CDI was developed as an additional module of the Integrated Management of Childhood Illness (IMCI)25 training course, which already has been delivered in >100 countries. Pilot studies in Brazil (I. Santos, MD, PhD, H. Goncalves, PhD, R. Halpern, PhD, C. Victora, MD, PhD, Pilot Test of the Child Development of the IMCI "Counsel the Mother" Module: Study Results and Recommendations, unpublished report, 1999) and South Africa (M. Chopra, Assessment of Participants on the Care for Development IMCI Training Course, unpublished report, 2001) suggest that CDI training improves the counseling skills of health care providers. Questions that remain unanswered are whether caregivers remember the CDI recommendations and apply them in the home and whether the CDI is "safe" to use during visits for an acute minor illness. Therefore, the purpose of this study was to determine the efficacy and the safety of the CDI when implemented during a young child’s visit for acute minor illness. We hypothesized that (1) caregivers who received the intervention would have more materials for stimulation and enhanced communication in their homes than a comparison group of caregivers who received standard care and (2) the addition of the CDI to sick-child visits would not decrease a caregiver’s compliance with treatment recommendations and there would not be a negative impact on the outcome of the illness.
METHODS
Study Design
The study design is a sequentially conducted controlled trial, with the comparison arm completed first, CDI training provided for the clinicians next, followed by the intervention arm. A randomized, controlled trial was not applied because it was considered important that both arms of the study be conducted by the same clinicians and that previous training in the CDI should not influence the standard care provided in the comparison arm of the study. One pediatrician (G.A.) was responsible for recruitment of participants. Two pediatricians (D.G.D. and B.E.B.) who had equal training and experience and were blinded to study aims and hypotheses before training for the CDI were instructed to provide routine care to patients in the comparison group. Subsequently, after CDI training, they were asked to apply the CDI to all of the patients in the intervention group. Six researchers who were experienced in child development and blinded to the aims and hypotheses of the study collected observational and interview information. Participants were informed that this was a study on child health and development and that there would be 2 groups receiving similar health care and 1 group given additional information. All participants provided written informed consent before enrollment. The study was approved by Ankara University Medical School Ethics Committee and the WHO Ethics Review Committee.
Setting and Participants
The study was conducted between March and June 2004 at the pediatric department outpatient clinic at Ankara University School of Medicine. This clinic provides services for children who come from low to middle socioeconomic backgrounds in Ankara, the capital city with a population of 4.5 million. Children were recruited when they were 24 months of age or younger and came to the clinic with a minor illness or well-child care and mothers were present during the clinic visit and were the primary caregivers in the home. Children who were clinically judged to be moderate to severely ill and those who lived outside Ankara were excluded.
Measures and Procedures
The measures (Table 1) were selected and developed after a comprehensive review of previously used and validated instruments. Researchers obtained 90% interobserver agreement on the instruments before the trial. One pediatrician (G.A.) screened all families who came to the clinic for eligibility criteria, obtained written consent, and used the Acute Illness Observation Scale26 to ensure eligibility. Children then were assigned in alternating order to 1 of 2 pediatricians (D.G.D. and B.E.B.), who provided routine pediatric care. The visit was observed by a researcher who used the Physician Counseling Skills Scale27 (I. Santos, MD, PhD, H. Goncalves, PhD, R. Halpern, PhD, C. Victora, MD, PhD, Pilot Test of the Child Development of the IMCI "Counsel the Mother" Module: Study Results and Recommendations, unpublished report, 1999) to assess the physician's competence in counseling caregivers on the child's health and development. At the end of each visit, the physician completed a structured form that included the child's diagnosis and the treatment recommendations. When the physician left the room, caregivers completed the Satisfaction with Physician Scale.28 Participants returned for a follow-up visit 1 week later, and at that visit, the same pediatrician who initially had seen the child examined the child for remaining symptoms of the illness and recorded on a structured form the outcome of the child's illness, any additional visits to other clinics, admissions to a hospital, and use of medication and other treatment modalities. Outcome of illness and compliance with treatment were determined by a separate review and coding of these records by 2 physicians who were blinded to group status. "Total compliance" was scored when the caregivers stated using all of the medications that were recommended by the pediatrician in the correct dosage and frequency. One month later, a second researcher, who had not met the family before and who was blind to the hypothesis and the aims of the study, conducted a home visit and administered the adapted Home Observation for Measurement of the Environment Inventory (HOME).29,30
When all of the clinic visits for the comparison group were completed, the 2 pediatricians participated in training and piloting of the CDI, after which the intervention group was enrolled. All measures and procedures were identical for the intervention group except for the addition of the CDI to each visit. After routine procedures, the pediatrician conducted the standard CDI interview14 to assess how the caregiver played and communicated with the child in the home. The physicians listened for and observed positive caregiver-child interactions, used specific praise and positive reinforcement throughout the visit, and showed the caregiver examples of play and homemade toys for increased caregiver-child communication and age-appropriate stimulation. One extra recommendation that was based on the Reach Out and Read program, which was developed and promoted in the United States,23,24 reading picture books to young children, also was included in the intervention. At the 1-week follow-up visit for the intervention group, pediatricians reinforced the CDI by praising the caregiver on added stimulation materials and communication to the child's environment; when the caregiver had not applied the recommendations, the reasons were sought and the importance of enhancing the child's environment was reiterated.
The main hypothesis of the study, that the intervention group would have more play and communication in the home than the control group, was assessed using the HOME. Although the HOME has not been standardized for children in Turkey or other developing countries, because of its ability to measure universally recognized nurturing and stimulating qualities in a child's environment, its excellent psychometric properties, and ability to predict later development, the HOME has been used in many developing countries.31–34 For this study, 5 experts in child development reviewed the HOME items and concluded that all items were culturally relevant and that 26 items could measure all of the goals of the CDI. The remaining 19 items were included to allow for comparisons of total scores with previous studies. The adaptation involved expanding items on toys to include homemade play materials in their appropriate categories. For example, if the caregiver provided clothespins for the child to place in a plastic bottle, then this play material was scored on the HOME scale as an eye-hand coordination toy.
Statistical Analysis
The main outcome was amount of stimulation provided to the child in the home (as observed by the adapted HOME scale) 1 month after the clinic visit. Sample size estimates were based on the potential to increase the proportion of participants with HOME scores 38 (a score that is predictive of optimal developmental outcome23) from 40% in the comparison group to 60% in the intervention group, with = .05 (2-tailed test) and power set at 1 – ? = .80. Allowing for 20% attrition, the minimum required enrollment was 128 per group. Statistical significance of differences between groups was examined using the 2 test and relative risks (RR) for categorical data and Mann Whitney U test for continuous data that are not normally distributed. In a logistic regression model, we examined the independent effects on optimal (38) HOME scores of child and caregiver characteristics that have been identified to affect home environments. These variables included group status, gender of child, age of child (<6 vs 6 months), having siblings, maternal and paternal education of secondary school or less (at most 8 years) versus high school or more education, nuclear (parents and children) versus traditional (extended family) family, housing situation (shanty houses versus apartment housing), insurance status (poverty insurance or none versus employment insurance), and maternal report of depressed mood. For all analyses, SPSS 11.5 was used.35
RESULTS
Of the 263 families approached, only 4 declined to participate and a total of 259 children were enrolled in the study: 129 and 130 in the comparison and intervention groups, respectively. The reasons and final diagnoses given for the visits included acute upper respiratory tract infection (36.9%), well-child care (18.0%), newborn problems (12.4%), dermatitis (8.6%), and other minor problems. As none of the families identified a primary health care provider, for all children in the study, this pediatric care included management of presenting illness as well as provision of preventive health care, such as immunizations and counseling for nutrition and safety. The mean duration of the initial visits were 25.6 minutes (SD: 6.1) in the comparison group and 36.9 minutes (SD: 10.5) in the intervention group (P < .01). The 1-week clinic visit and the 1-month home visit were complete for 233 children, 113 (87.6%) and 120 (92.3%) in the comparison and intervention groups, respectively. Families' visits outside Ankara and family illness that prevented appointments were the major reasons for loss to follow-up. There were no significant differences in severity of illness (as measured by the Acute Illness Observation Scale) or any of the baseline sociodemographic characteristics between those who completed the study and the 26 who were lost to follow-up. The results pertain to the 233 families with complete follow-up. As seen in Table 2, there were no significant differences between the intervention and comparison groups on any of the sociodemographic variables. Most children were 12 months or younger, were the only children in the homes, and had mothers and fathers with at most high school education.
At the 1-month home visit, 95.0% and 13.3% of caregivers in the intervention and comparison groups, respectively, stated that the pediatrician provided information on promoting their child's development. As seen in Table 3, in the intervention group, more caregivers themselves or other family members had tried a new play activity with the child in the past month than in the comparison group. Significant differences were not found between the intervention and comparison groups on the total score of the HOME (median: 31.5 and 31.0, respectively; P = .262), but the proportion of HOME scores 38 were significantly higher in the intervention than comparison group. Scores of items on subscales that pertained to the caregiver's communication with the child ("responsivity of the caregiver," "acceptance of child by caregiver," and "caregiver involvement with child") were not significantly different between the 2 groups. In contrast, items on subscales "learning materials and toys provided to child" and "opportunities for variety in daily stimulation" accounted for the differences. As seen in Table 3, in the past month, more families in the intervention group had made at least 1 toy for their child and reported reading to their children at least twice a week than in the comparison group. Three independent predictors of optimal HOME score emerged from the logistic regression analysis: being in the intervention group (adjusted RR: 3.2; 95% confidence interval [CI]: 1.2–8.3), child age >6 months (adjusted RR: 7.7; 95% CI: 2.5–23.7), and maternal education greater than secondary school (adjusted RR: 5.5; 95% CI: 1.8–17.1).
At the 1-week follow-up visit, of the 191 (82.0%) children with minor illness, 78.8% (78) and 72.8% (67) of children in the intervention and comparison groups, respectively, were determined by caregiver history and pediatricians' examinations to have recovered from the initial illness (RR: 0.9; 95% CI: 0.8–1.1). The total number of families who had taken their children for a second visit to a health center for the presenting illness was 33 (17.3%), with no significant group difference in distribution. Of the 180 children who were prescribed medications, 78 (87.6%) of 89 and 70 (76.9%) of 91 (RR: 0.9%; 95% CI: 0.8–1.0) caregivers in the intervention and comparison groups, respectively, totally complied with treatment. Unwarranted medications, such as antibiotics that were not recommended by the pediatricians, were used by 16.5% (15) of caregivers in the comparison group versus 7.9% (7) of caregivers in the intervention group (RR: 2.1%; 95% CI: 0.9–4.9).
After the CDI training, physicians were observed to use 2 counseling skills more frequently: encouraging the caregiver to talk (observed in 45.1% and 99.2% of the visits before and after CDI training, respectively; P < .001) and encouraging the caregiver to ask questions (observed in 42.5% and 85.8% of the visits before and after CDI training, respectively; P < .001). The median total scores on the Satisfaction with Physician Scale were 60 (range: 40–60) in the intervention group compared with 59 (range: 37–60) in the comparison group (P < .001).
DISCUSSION
This study is the first to use a controlled trial to test the efficacy and the safety of the CDI, a new intervention that is to be promoted by the WHO and UNICEF. We have shown that delivering of CDI messages during acute health care visits by trained physicians resulted in more optimal stimulation in the home environments of the intervention group than in a comparable group of young children who were seen by the same physicians before their CDI training. Being in the intervention group remained a significant predictor of optimal home scores when we controlled for other caregiver and child characteristics.
The few controlled trials that have examined the effects of addressing child development during routine health care encounters have been conducted in Western populations and during visits for well-child care, when parents are more likely to be more receptive to receiving information.6,22 The question that was addressed for the first time in this study was whether the CDI intervention is efficacious when delivered during 1 acute visit and its follow-up to caregivers who likely are concerned with the physical health of their child and who have no previous relationship with the health provider. This is the prevalent scenario in developing countries where children rarely receive continuous well-child care. The CDI adds 10 minutes to a health care encounter; this is comparable to other interventions that involve counseling, such as those that promote breastfeeding, optimal nutrition, or home safety. The concrete outcome of this brief intervention, that caregivers in the intervention group were 4 times more likely to make toys for their young children than those in the control group, has important implications. It indicates that caregivers not only comprehended the importance of stimulation for their child's development but also put thought, time, effort, and creativity into provide this stimulus. This study also has shown that messages other than those that are present in the generic CDI can be added to the intervention. A simple 1-time recommendation about reading to young children that is based on the intensive Reach Out and Read model resulted in salient benefits. We speculate that the success of these brief interventions in engaging caregivers is attributable to the trust in the importance of information that is received from health care providers, the novelty and the attraction of learning how to help children develop, the concreteness and simplicity of the recommendations, and the joyful response that these interventions elicit from the children.
Although the majority of families reported remembering the intervention and messages, not all families were shown to act on these messages. To eliminate the Hawthorne effect, the HOME scale was applied once, after the intervention. We cannot examine, therefore, whether families with lower baseline HOME scores benefited more from the intervention. Higher maternal education and older age of child predicted optimal HOME scores independent of the intervention. Maternal education is widely known as a significant predictor of child health and development. Our findings emphasize the importance of the education of women in promoting the development of their children. The results also suggest that special attention should be given to youngest infants, who may be of highest risk for understimulation. Caregiver-child communication, a major focus of the CDI, was not significantly different between the intervention and comparison groups in this study. In this sample, in which caregiver responsivity and communication already were high, we may not have used sensitive measures to observe this effect. It also is possible that caregiver communication, being a complex construct,3 requires more intensive interventions than the CDI, which is applied on few occasions. Studies in South Africa and Brazil have demonstrated that interventions with greater intensity than the CDI (1 involving 22 hour-long sessions36 and the other involving a 50-minute training session postpartum37) had a positive effect on mother-child communicative interactions. Future studies are needed to investigate ways in which the CDI can be intensified to have a larger impact, particularly on caregiver-child communicative interactions, and to provide a precise measurement of this impact.
This study provides reassurance for plans to incorporate the CDI with the IMCI. The addition of the CDI to sick-child visits did not adversely affect the outcome of the acute illnesses or the caregivers' compliance with treatment. Because this was a study of efficacy that was conducted under controlled conditions and because of the limitations of obtaining information on compliance with treatment from parents, we recommend that this important question be investigated further in future studies of effectiveness. The benefits of linking the CDI to the IMCI are obvious. The IMCI targets infants and young children, who often are brought for nutritional counseling or acute illness. These same children most likely will benefit from messages on child development. The CDI when linked to IMCI therefore should cover children who are in most need. The strategy of using health care visits to monitor child development long has been recognized.38,39 Linking of the CDI to the IMCI broadens this strategy by using the opportunity of the health visit for minor illness to promote development.
Previous studies have shown that CDI training increases the counseling skills of health care providers (I. Santos, MD, PhD, H. Goncalves, PhD, R. Halpern, PhD, C. Victora, MD, PhD, Pilot Test of the Child Development of the IMCI "Counsel the Mother" Module: Study Results and Recommendations, unpublished report, 1999; M. Chopra, MD, PhD, Assessment of Participants on the Care for Development IMCI Training Course, unpublished report, 2001). In this study, key elements of counseling—encouraging caregivers to talk and ask questions—were significantly enhanced with CDI training. Caregivers' satisfaction with physicians was high in both groups and although reaching a statistically significant difference, was not meaningfully different between the 2 groups. We have anecdotal evidence that the physicians felt more confident in their relationship with caregivers after they received the CDI training, and more caregivers in the intervention group remarked on the physicians' positive attitude 1 month after the contact. Future studies are needed to determine whether the CDI has a positive impact on caregiver-health care provider relationships and the use of health care services. The CDI would provide a more comprehensive approach to child development if it also could be linked to a system that determines a community's opportunities and priorities on child development and that has professionals trained in identifying and treating children with developmental delays and providing in-depth counseling that is specific to the child's and the family's needs.
The generalizability of this study sample is limited; it is representative of low- to middle-income children who lived in Ankara and whose mothers were not working outside the home. Children in this sample seem to be at low risk for poor developmental outcomes: they were well nourished and cared for, the families were intact, and the fathers were employed. The mean adapted HOME scores, however, were comparable to high-risk samples in Western countries. In a study in the United States of children who were 2 years of age and at risk for being removed from their families as a result of abuse or neglect, the mean HOME score was 31.7 (SD: 6.0) compared with 30.4 (SD: 6.1) in our study.40 Factors that are associated with risk and resilience in home environments differ between populations and need to be identified to guide interventions.15 In our study, despite high scores on caregiver responsivity and involvement, stimulation for young children was suboptimal.
The long-term effects on child development of such a brief intervention as the CDI are unknown. The WHO justifies the dissemination of this intervention on the basis of the widely known long-term benefits to child development of optimal stimulation during early childhood and the child rights initiative that calls for the "state-of-the-art" information on child health and development to be delivered rapidly for the benefit of all children across the world. The demonstration in this study of the efficacy of this brief intervention and its safety during sick-child visits suggests that the CDI can be recommended globally to be used during health care delivery. Future studies of the effectiveness of the CDI are needed to determine whether it can be applied and sustained for large populations in clinical practice and to determine the long-term effects of this intervention on the caregiving environment of children and on health care provider-caregiver relationships.
CONCLUSIONS
Developing countries are not benefiting from the state-of-the-art of health and early childhood programs in developed nations.12,41–43 The feasibility of the CDI, the brevity of the training for any health professional, and the CDI's ease of application during acute visits make the CDI a unique intervention with the potential of having an impact on child development, particularly throughout the developing world. Its rapid dissemination is needed to begin decreasing the discrepancies between developed and developing countries with regard to the promotion of child development.
ACKNOWLEDGMENTS
This study was funded by a grant from the Department of Child and Adolescent Health and Development of the World Health Organization (project ID: 03011 HNI).
We thank Drs Jose Martines, Jane Lucas, Meena Cabral, Patrice Engle, and Linda Richter for invaluable contributions to the CDI. We express gratitude to Drs Paul McCarthy, Bettye Caldwell, and Patrick Casey for generous permission to use their instruments; Drs John Leventhal, Brian Forsyth, Eugene Shapiro, and Frank Oberklaid for critique of the study design, analysis, and interpretation of the data; and Derya ?ztuna for help with the statistical analysis. We thank the families for volunteering; Canan Gül G?k, Hanife Gülnur ?zdemir, Gülden ?ztürk, G?nül Erdoan, and Habibe Dilsiz for contributions to the collection of the data; and Nermin Sezer for secretarial support.
FOOTNOTES
Accepted Feb 6, 2006.
Address correspondence to Ilgi Ozturk Ertem, MD, Ankara University School of Medicine, Department of Pediatrics, Developmental-Behavioral Pediatrics Unit, Cebeci, Ankara 06100, Turkey. E-mail: ertemilgi@yahoo.com
The authors have indicated they have no financial relationships relevant to this article to disclose.
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Developmental-Behavioral Pediatrics Unit, Department of Pediatrics, Ankara University School of Medicine, Ankara, Turkey(Ilgi Ozturk Ertem, MD, Gu)