MedTrace Logo

Caregiver Interventions for Developmental Delays in Young Kenyan Children

NCT03612505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-06-18

No results posted yet for this study

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.

Conditions

  • Child Development
  • Parenting
  • Cognitive Developmental Delay

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2019-02-14
Completion
2019-09-30

Countries

  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612505 on ClinicalTrials.gov