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Intervention on Development and Growth at Children in Poverty

NCT ID: NCT02988180

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Child Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type OTHER

basic services

Intervention Type 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.

the play-based developmental stimulation

Intervention Type 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.

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.

Group Type OTHER

basic services

Intervention Type 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.

Interventions

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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 Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jimma University

OTHER

Sponsor Role collaborator

VLIR-UOS (Vlaamse Interuniversitaire Raad).

UNKNOWN

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Marita Granitzer

prof.dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teklu Gemechu Abessa

Role: STUDY_CHAIR

Jimma University

Mekitie Wondafrash, nutritionist

Role: STUDY_CHAIR

Jimma University

Patrick Kolsteren, prof.dr

Role: STUDY_CHAIR

University Ghent

Berhanu Nigussie Worku, psychologist

Role: STUDY_CHAIR

Jimma University

Locations

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Ghent University

Ghent, , Belgium

Site Status

2. Jimma University

Jimma, , Ethiopia

Site Status

Countries

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Belgium Ethiopia

References

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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.

Reference Type DERIVED
PMID: 29402258 (View on PubMed)

Other Identifiers

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DGSC-2015

Identifier Type: -

Identifier Source: org_study_id