Clinical trial NCT03612505: Caregiver Interventions for Developmental Delays in Young Kenyan Children
Official title: Caregiver Interventions for Developmental Delays in Young Kenyan Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Parenting
Cognitive Developmental Delay
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change In Perspectives around Child Development, gathered by Focus Group Discussions
timeFrame: Baseline and 6 months
measure: Change In Perspectives around Child Development, gathered by Focus Group Discussions
timeFrame: 6 months and 12 months
measure: Change in mother interactions, gathered by video-taped mother interactions
timeFrame: Baseline and 6 months
measure: Change in mother interactions, gathered by video-taped mother interactions
timeFrame: 6 months and 12 months
measure: Change in Home Observations Measurement of the Environment (HOME) scores
timeFrame: Baseline, 6 months, 12 months
measure: Change in MacArthur-Bates Communication Developmental Inventory (CDI) scores
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University School of Medicine
state: Uasin Gishu
Study officials:
References: