Caregiver Interventions for Developmental Delays in Young Kenyan Children

NCT ID: NCT03612505

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-13
• Study Completion Date: 2019-09-30

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.

Conditions

Child Development; Parenting; Cognitive Developmental Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention

Group Type: ACTIVE_COMPARATOR

Mother groups using principles of UNICEF/World Health Organization's Care for Child Development

Intervention Type: BEHAVIORAL

The intervention is expected to occur every two weeks for a total of ten sessions. On the study day, the child- caregiver dyads randomised to intervention group will be shown to the study room. Each intervention session will be estimated to last 90 minutes allocated as follows: 6

• Introduction (10 minutes)
• Lesson on *Early Childhood Development* topic (20 minutes)
• Discussions on strengthens in caregiving around this topic and areas for improvement (30 minutes)
• Observe caretakers one-on-one in play role with the child (25 minutes)
• Wrap up/Re-cap (5 minutes) Early Childhood development topics that will be covered include per session are: i) Importance of early childhood development ii) Showing love and building trust iii) Awareness of child's well-being iv) Consistency and daily routines v) Discipline and correction vi) consistency and daily routines vii) Nutrition and cleanliness Viii) Importance of play iX) Dealing with life stresses X) Planning for the future

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mother groups using principles of UNICEF/World Health Organization's Care for Child Development

The intervention is expected to occur every two weeks for a total of ten sessions. On the study day, the child- caregiver dyads randomised to intervention group will be shown to the study room. Each intervention session will be estimated to last 90 minutes allocated as follows: 6

• Introduction (10 minutes)
• Lesson on *Early Childhood Development* topic (20 minutes)
• Discussions on strengthens in caregiving around this topic and areas for improvement (30 minutes)
• Observe caretakers one-on-one in play role with the child (25 minutes)
• Wrap up/Re-cap (5 minutes) Early Childhood development topics that will be covered include per session are: i) Importance of early childhood development ii) Showing love and building trust iii) Awareness of child's well-being iv) Consistency and daily routines v) Discipline and correction vi) consistency and daily routines vii) Nutrition and cleanliness Viii) Importance of play iX) Dealing with life stresses X) Planning for the future

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Megan Song McHenry

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Moi University School of Medicine

Eldoret, Uasin Gishu County, Kenya

Countries

Kenya

Other Identifiers

1801879405

Identifier Type: -

Identifier Source: org_study_id