NCT02988180

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

November 17, 2016

Last Update Submit

December 7, 2016

Conditions

Child Malnutrition

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (6)

  • weight

    baseline

  • weight

    3 months

  • weight

    6 months

  • Height

    baseline

  • Height

    3 months

  • +1 more secondary outcomes

Study Arms (2)

intervention group

OTHER

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 servicesOther: the play-based developmental stimulation

control group

OTHER

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

Interventions

basic servicesOTHER

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.

control groupintervention group
the play-based developmental stimulationOTHER

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.

intervention group

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with observable physical disabilities which hinders mobility;
  • Children with severe mental retardation;
  • Children with discernable hearing and visual impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University

Ghent, Belgium

Location

2. Jimma University

Jimma, Ethiopia

Location

Related Publications (1)

  • 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.

    PMID: 29402258DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.dr.

Study Record Dates

First Submitted

November 17, 2016

First Posted

December 9, 2016

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12

Locations

ET(1)BE(1)