Intervention on Development and Growth at Children in Poverty

Not Applicable

Completed

• Conditions: Child Malnutrition
• Interventions: Other: basic services; Other: the play-based developmental stimulation

• Registration Number: NCT02988180
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-11-17
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Study First Posted: 2016-12-09
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	the play-based developmental stimulation	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.
control group	basic services	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.
intervention group	basic services	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
weight	6 months	A child's weight was measured by using a calibrated electronic weighing scale.
Height	6 months	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.

Trial Locations

Locations (2)

Ghent University; 🇧🇪 Ghent, Belgium

2. Jimma University; 🇪🇹 Jimma, Ethiopia