Intervention on Development and Growth at Children in Poverty

Child Malnutrition Clinical Trial

— RAI  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988180
• Other study ID #: DGSC-2015
• Status: Completed
• Phase: N/A
• First received: November 17, 2016
• Last updated: December 7, 2016
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardEthiopia: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 59 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Ethiopia	2. Jimma University	Jimma

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Jimma University, VLIR-UOS (Vlaamse Interuniversitaire Raad).

Countries where clinical trial is conducted

Belgium,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal-social outcome	Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis	baseline	No
Primary	Personal-social outcome	Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis	month 3	No
Primary	Personal-social outcome	Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis	month 6	No
Primary	fine motor outcome	Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis	baseline	No
Primary	fine motor outcome	Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis	3 months	No
Primary	fine motor outcome	Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis	6 months	No
Primary	gross motor outcome	Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis	baseline	No
Primary	gross motor outcome	Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis	3 months	No
Primary	gross motor outcome	Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis	6 months	No
Primary	language outcome	Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis	baseline	No
Primary	language outcome	Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis	3 months	No
Primary	language outcoome	Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis	6 months	No
Primary	Social-emotional outcome	Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children	baseline	No
Primary	Social-emotional outcome	Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children	3 months	No
Primary	Social-emotional outcome	Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children	6 months	No
Secondary	weight	A child's weight was measured by using a calibrated electronic weighing scale.	baseline	No
Secondary	weight	A child's weight was measured by using a calibrated electronic weighing scale.	3 months	No
Secondary	weight	A child's weight was measured by using a calibrated electronic weighing scale.	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No