Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03612505
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT03612505
Study Brief:
Protocol Section:
NCT03612505