Intervention on Development and Growth at Children in Poverty

Study Overview
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Brief Summary
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Children in extreme poverty lack adequate care and face increased health risks. The earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. There is, however, growing evidence that early interventions can prevent the negative consequences. Such interventions are effective, particularly when they are of high quality, organized at home and parents are involved. Recently, baseline assessment of developmental and nutritional status of SOS children and children in extreme poverty in Jimma region of South-West Ethiopia revealed that these children have developmental problems in language, motor, social-emotional skills and nutritional status. The impact of play-oriented stimulation activities integrated into the existing SOS basic program, on developmental outcomes, has never been investigated in this context. The main objective of the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS program on the developmental outcomes of children living with foster families. This was done by comparing the intervention children with their age-matched children (control), not receiving the stimulation package. It was hypothesized that this package would significantly improve the developmental skills of these children.

Official Title
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Developmental and Growth Status of Children (6-60 Months of Age) in Extreme Poverty in Jimma Town of Ethiopia: Effects of Developmental Stimulation - RAI (Risk Analysis and Intervention)

Conditions
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Child Malnutrition

Intervention / Treatment
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* Other: basic services
* Other: the play-based developmental stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who were selected by the SOS children's village as lacking parental care and receive basic services; Children living in Jimma town; Children from 3 months to 59 months of age. Exclusion Criteria: Children with observable physical disabilities which hinders mobility; Children with severe mental retardation; Children with discernable hearing and visual impairments.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intervention group<br>Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services. | Other: basic services<br>* The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.<br>Other: the play-based developmental stimulation<br>* Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.<br>|
| Other: control group<br>The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation. | Other: basic services<br>* The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal-social outcome | Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis | baseline | 
| Personal-social outcome | Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis | month 3 | 
| Personal-social outcome | Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis | month 6 | 
| fine motor outcome | Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis | baseline | 
| fine motor outcome | Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis | 3 months | 
| fine motor outcome | Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis | 6 months | 
| gross motor outcome | Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis | baseline | 
| gross motor outcome | Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis | 3 months | 
| gross motor outcome | Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis | 6 months | 
| language outcome | Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis | baseline | 
| language outcome | Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis | 3 months | 
| language outcoome | Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis | 6 months | 
| Social-emotional outcome | Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children | baseline | 
| Social-emotional outcome | Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children | 3 months | 
| Social-emotional outcome | Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | A child's weight was measured by using a calibrated electronic weighing scale. | baseline | 
| weight | A child's weight was measured by using a calibrated electronic weighing scale. | 3 months | 
| weight | A child's weight was measured by using a calibrated electronic weighing scale. | 6 months | 
| Height | For children under two years of age, a length measuring board on a flat table was used. For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer. | baseline | 
| Height | For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer. | 3 months | 
| Height | For children under two years of age, a length measuring board on a flat table was used. The height of a child above two years of age was measured by using a portable stadiometer. | 6 months |