Clinical trial NCT02988180: Intervention on Development and Growth at Children in Poverty
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jimma University
name: VLIR-UOS (Vlaamse Interuniversitaire Raad).
First posted: 2016-12-09
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Personal-social outcome
timeFrame: baseline
measure: Personal-social outcome
timeFrame: month 3
measure: Personal-social outcome
timeFrame: month 6
measure: fine motor outcome
timeFrame: baseline
measure: fine motor outcome
timeFrame: 3 months
measure: fine motor outcome
timeFrame: 6 months
measure: gross motor outcome
timeFrame: baseline
measure: gross motor outcome
timeFrame: 3 months
measure: gross motor outcome
timeFrame: 6 months
measure: language outcome
timeFrame: baseline
measure: language outcome
timeFrame: 3 months
measure: language outcoome
timeFrame: 6 months
measure: Social-emotional outcome
timeFrame: baseline
measure: Social-emotional outcome
timeFrame: 3 months
measure: Social-emotional outcome
timeFrame: 6 months
Secondary outcomes:
measure: weight
timeFrame: baseline
measure: weight
timeFrame: 3 months
measure: weight
timeFrame: 6 months
measure: Height
timeFrame: baseline
measure: Height
timeFrame: 3 months
measure: Height
timeFrame: 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Jimma
country: Ethiopia
facility: 2. Jimma University
Study officials:
affiliation: Jimma University
name: Teklu Gemechu Abessa
role: STUDY_CHAIR
affiliation: Jimma University
name: Mekitie Wondafrash, nutritionist
role: STUDY_CHAIR
affiliation: University Ghent
name: Patrick Kolsteren, prof.dr
role: STUDY_CHAIR
affiliation: Jimma University
name: Berhanu Nigussie Worku, psychologist
role: STUDY_CHAIR
References:
citation: 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.