Intervention on Development and Growth at Children in Poverty (RAI)

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)

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.

Study Overview

• Status: Completed
• Conditions: Child Malnutrition
• Intervention / Treatment: Other: basic services; Other: the play-based developmental stimulation

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Ghent University
• Ethiopia
  • Jimma, Ethiopia
    • 2. Jimma University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: intervention group; 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; 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: 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.
Other: control group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jimma University; VLIR-UOS (Vlaamse Interuniversitaire Raad).
• Investigators: Study Chair: Teklu Gemechu Abessa, Jimma University; Study Chair: Mekitie Wondafrash, nutritionist, Jimma University; Study Chair: Patrick Kolsteren, prof.dr, University Ghent; Study Chair: Berhanu Nigussie Worku, psychologist, Jimma University

Publications and helpful links

General Publications

• Worku BN, Abessa TG, Wondafrash M, Lemmens J, Valy J, Bruckers L, Kolsteren P, Granitzer M. Effects of home-based play-assisted stimulation on developmental performances of children living in extreme poverty: a randomized single-blind controlled trial. BMC Pediatr. 2018 Feb 5;18(1):29. doi: 10.1186/s12887-018-1023-0.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 7, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: DGSC-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED