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Completed

NCT Number: NCT02988180

Intervention on Development and Growth at Children in Poverty

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.

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Key information

Conditions

Child Malnutrition Child Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

3 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

basic services

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

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.

Primary outcomes

  1. Personal-social outcome

    Time frame: baseline

    Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis

  2. Personal-social outcome

    Time frame: month 3

    Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis

  3. Personal-social outcome

    Time frame: month 6

    Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis

  4. fine motor outcome

    Time frame: baseline

    Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis

  5. fine motor outcome

    Time frame: 3 months

    Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis

  6. fine motor outcome

    Time frame: 6 months

    Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis

  7. gross motor outcome

    Time frame: baseline

    Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis

  8. gross motor outcome

    Time frame: 3 months

    Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis

  9. gross motor outcome

    Time frame: 6 months

    Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis

  10. language outcome

    Time frame: baseline

    Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis

  11. language outcome

    Time frame: 3 months

    Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis

  12. language outcoome

    Time frame: 6 months

    Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis

  13. Social-emotional outcome

    Time frame: baseline

    Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children

  14. Social-emotional outcome

    Time frame: 3 months

    Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children

  15. Social-emotional outcome

    Time frame: 6 months

    Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children

Secondary outcomes

  1. weight

    Time frame: baseline

    A child's weight was measured by using a calibrated electronic weighing scale.

  2. weight

    Time frame: 3 months

    A child's weight was measured by using a calibrated electronic weighing scale.

  3. weight

    Time frame: 6 months

    A child's weight was measured by using a calibrated electronic weighing scale.

  4. Height

    Time frame: baseline

    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.

  5. Height

    Time frame: 3 months

    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. Height

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jimma University
  • VLIR-UOS (Vlaamse Interuniversitaire Raad).

Registry information

Official study 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)

Acronym: RAI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2016
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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