Child Development Clinical Trial
Official title:
Caregiver Interventions for Developmental Delays in Young Kenyan Children
Verified date | June 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for sustainability. If the clinic-based group sessions prove to be effective for young children with neurodevelopmental delays, this would help inform the key areas of fidelity needed to maintain effectiveness of the intervention. This study is a critical first step to evaluating the Care for Child Development Intervention (CCDI) program's potential as a cross-cultural intervention that is sustainable and effective for the children at highest risk for neurodevelopmental delay. These results will have significant impacts in improving early childhood neurodevelopment both in Kenya and worldwide.
Status | Completed |
Enrollment | 31 |
Est. completion date | September 30, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 24 Months |
Eligibility | Inclusion Criteria: - age 18-24 months - communicate in either English or Kiswahili - Score < 85 on one of the BSID-III subscales (mild/moderate/severe delay in cognitive, motor, or language). - Have a caregiver who can communicate in English or Kiswahili - Have a caregiver responsible for child's daily activities Exclusion Criteria: - Profound neurological impairment, such as severe cerebral palsy, deafness, or blindness preventing them from participating in the groups. |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi University School of Medicine | Eldoret | Uasin Gishu |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores | Measures cognitive, language, and motor development. Composite scores for cognitive (range of scores 55-145), language (range of scores 47-153), and motor (range of scores 46-154) development. Lower scores indicate worse development. Subscales (e.g. fine and gross motor for motor and expressive and receptive language for language) are summed to create the composite score. | Baseline, 6 months, 12 months | |
Secondary | Change In Perspectives around Child Development, gathered by Focus Group Discussions | Qualitative interviews with caregivers in Group 1, who will receive the intervention during the first 6 months of the study. Qualitative interviews will also be performed with Group 2 to see if there were any changes in perspectives on child development without the intervention | Baseline and 6 months | |
Secondary | Change In Perspectives around Child Development, gathered by Focus Group Discussions | Qualitative interviews with caregivers in Group 2, who will receive the intervention during the second 6 months of the study. Qualitative interviews will also be performed with Group 1 to see if there were any changes in perspectives on child development after the intervention has ceased | 6 months and 12 months | |
Secondary | Change in mother interactions, gathered by video-taped mother interactions | Coding of mother's interactions with children while waiting. We will compare Group 1, who will receive the intervention during the first 6 months, as well as Group 2, who will not be receiving the intervention during this interval | Baseline and 6 months | |
Secondary | Change in mother interactions, gathered by video-taped mother interactions | Coding of mother's interactions with children while waiting. We will compare Group 2, who will receive the intervention during the first 6 months, as well as Group 1, who had received the intervention but not longer is receiving it in the second 6 months. | 6 months and 12 months | |
Secondary | Change in Home Observations Measurement of the Environment (HOME) scores | Structured observations and questions performed in a families home. Subscales are as follows: Responsivity (score range 0-11), acceptance (0-8), organization (0-6), learning materials (0-9), involvement (0-6), variety (0-5). The lower scores indicate worse performance. These subscales are summed to give the total score. | Baseline, 6 months, 12 months | |
Secondary | Change in MacArthur-Bates Communication Developmental Inventory (CDI) scores | Language. Scale range is 0-100, with the lower scores indicating worse performance. No subscales will be used in this study. | Baseline, 6 months, 12 months |
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