Child Development Clinical Trial
Official title:
Caregiver Interventions for Developmental Delays in Young Kenyan Children
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.
Objectives:
The broad objective of this proposal is to pilot the CCDI program as an intervention to treat
neurodevelopmental delays among 56 young children in Kenya
Specific Aims:
Aim 1: Determine the feasibility of a randomized controlled trial protocol to examine the
effectiveness of the CCDI Program for Kenyan children with neurodevelopmental delays aged
18-24 months within a public Maternal-Child Health (MCH) clinic setting.
Hypothesis: The CCDI Program will be feasible, as measured by ≥90% of participants being
willing to be randomized to either the intervention or the control group; ≥ 80% attending all
10 biweekly caregiver meetings; ≥80% of children returning for their 6 month follow-up; and
≥80% returning for 12 month follow-up.
Aim 2: Determine the acceptability, facilitators, and barriers of the CCDI Program for use in
eligible children.
Hypothesis: The CCDI Program will be acceptable, as determined by an analysis of prospective,
concurrent, and retrospective acceptability, and specific facilitators and barriers to the
program will be identified. Using focus group discussions and semi-structured interviews with
caregivers, clinical providers, and community leaders, the investigators will determine
aspects of the program are acceptable, facilitators, and barriers to improved
neurodevelopmental care and allow the CCDI program to function optimally in this setting.
Aim 3: Estimate the effect size of the CCDI Program to reduce neurodevelopmental delays in
young Kenyan children.
Hypothesis: The investigators will demonstrate a 40% decrease in the number of children with
neurodevelopmental delays, as determined by a culturally adapted Bayley Scales of Infant and
Toddler Development, 3rd edition (BSID-III) standardized score with implementation of the
CCDI Program. This data will inform sample size justification for a future intervention
study.
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