Evaluation of the feasibility and effectiveness of a health facility-based combined with home-based early childhood development (ECD) intervention in Siaya County, Kenya

Not Applicable

Completed

• Conditions: Child growth development; Not Applicable

• Registration Number: ISRCTN11561283
• Lead Sponsor: African Population and Health Research Center

Brief Summary

2022 Results article in https://doi.org/10.1371/journal.pone.0265366 (added 23/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Study Completion: 2021-10-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 699

Inclusion Criteria

1. Pregnant women aged 15+ years who are in their third trimester
2. Using the ANC services in the selected facilities
3. Provide consent to participate in the study
4. All the children will be recruited shortly after birth - this will include children with any form of disability as the intervention also targets such children

Exclusion Criteria

Caregivers with mental impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Caregiver’s knowledge, attitudes and practices regarding early child development (stimulation and responsive caregiving), assessed using structured questionnaire at: <br>T0 (Pre-birth) last trimester of pregnancy<br>T1 (Month 1-2) at child age 2 months<br>T2 (Month 9-10) at child age 10 months <br>T3 (Month 17-18) at child age 18 months<br>T4 (Month 25-28) at child age 27 months

Secondary Outcome Measures

Name	Time	Method
1. Child growth and developmental outcomes, assessed using Ages and Stages Questionnaire Version 3 (ASQ-3)<br>2. Caregiver practice, assessed using Multiple Indicator Cluster Survey (MICS)<br>3. Operational feasibility and cost and cost-effectiveness of the health facility-based plus home-based ECD intervention <br><br>Measured at:<br>T0 (Pre-birth) last trimester of pregnancy<br>T1 (Month 1-2) at child age 2 months<br>T2 (Month 9-10) at child age 10 months <br>T3 (Month 17-18) at child age 18 months<br>T4 (Month 25-28) at child age 27 months