Improve Child Outcomes Through Caregiving in Cambodia

NCT05197985 | Terminated

• 1 other identifier: RTIInternational
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a longitudinal, randomized-controlled study with a stepped-wedge research design. The Integrated Early Childhood Development Activity (IECD) will implement interventions in three cohorts of villages sequentially across two provinces of Cambodia, Kampong Thom and Preah Vihear. IECD will collect data from all three cohorts together, four times, at 12-month intervals: a baseline prior to any program intervention, a Cohort 1 end line, a Cohort 2 end line and a Cohort 3 end line. IECD's Theory of Change is that by changing caregivers' practices in rearing their children under age 5, those children will demonstrate improvements in child development outcomes. The investigators will use 6 instruments to collect this data, including well-established internationally validated measures. The IECD team enrolled 1,790 households in Preah Vihear and Kampong Thom in June and July 2021. The study will be competed in 2025.

Conditions

Child Development

Keywords

Cambodia; Nurturing Care; Caregiving; Child Outcomes; ECD

Outcome Measures

Primary Outcomes (2)

• Caregiver Report of Early Development Index (CREDI Instrument) - Child Development

  This instrument is used to measure the primary outcome of child development. It is a caregiver-reported questionnaire to measure of developmental status of children aged 6-23 months across developmental domains. The developmental domains are: 1. Motor Skills (fine and gross) 2. Language (receptive and expressive) 3. Cognition (executive function, problem solving \& reasoning, and pre-academic knowledge) 4. Social-Emotional (emotional \& behavioral self-regulation, emotional knowledge, social competence) 5. Mental Health (internalizing, externalizing) The scale score is from 0-20. Higher score is optimal. Developed by Harvard. For more information, see https://sites.sph.harvard.edu/credi/.

  12 months

• Early Childhood Development Indicators (ECDI Instrument) - Child Development

  This instrument is used to measure the primary outcome of child development. It is a caregiver-reported questionnaire to measure of developmental status of children aged 24-59 months across domains of learning, psychological well-being, and health, and 12 sub-domains. The scale score is from 0-20. Higher score is optimal. Developed by UNICEF. For more information, see https://data.unicef.org/resources/early-childhood-development-index-2030-ecdi2030/.

  12 months

Secondary Outcomes (4)

• Integrated Early Childhood Development Caregiving Key Behaviors (ECDI Instrument)

  12 months

• World Health Organization Minimum Acceptable Diet Instrument (children aged 6-23 months)

  12 months

• WHO Prevalence of Exclusive Breastfeeding Instrument (children aged 0-6 months)

  12 months

• WHO Minimum Dietary Diversity-Women (MDD-W) Instrument

  12 months

Study Arms (2)

Integrated Early Childhood Development Intervention

EXPERIMENTAL

Integrated Early Childhood Development Intervention is one intervention package. Inclusion criteria are adults (age 18+) who are primary caregiver of one or more children under the age of 5 years; and pregnant women (age 18+).

Behavioral: IECD Intervention

Control Arm

NO INTERVENTION

This is the control arm that receives no intervention. Inclusion criteria are adults (age 18+) who are primary caregiver of one or more children under the age of 5 years; and pregnant women (age 18+).

Interventions

IECD Intervention BEHAVIORAL

The Nurturing Care curriculum contains: 1) responsive caregiving, 2) the important role everyone plays in raising a child, 3) maternal health and nutrition, 4) responsive feeding and good nutrition, 5) how children grow and develop, 6) hygiene, 7) language development, 8) the importance of play, 9) managing the stress of parenting, 10) protecting your child from harm. Modules will be delivered through group sessions for caregivers, individualized home visits and Social Behavior Change Communication. IECD will build families' capacity to grow and raise healthy food to consume themselves, and connect them to agricultural markets. Specifically, IECD will provide agriculture technical training to Village Model Farms and households, and will facilitate linkages to markets by identifying buyers and connecting them to the farmers. IECD will train and support volunteers to conduct disability screening, and train disability interventionists to provide appropriate therapies and support services.

Integrated Early Childhood Development Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age 18+) caregivers of one or more child(ren) under the age of 5 years old
• Adult (age 18+) pregnant women

You may not qualify if:

• None

Sponsors & Collaborators

• RTI International: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

• King KM, Yeng S, Brennan C, Creel D, Ames JW, Cotes G, Bann CM, Black MM. Integrated Early Childhood Development in Cambodia: Protocol of a Cluster Stepped-Wedge Trial. Pediatrics. 2023 May 1;151(Suppl 2):e2023060221N. doi: 10.1542/peds.2023-060221N.

  PMID: 37125891 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collectors will not know which families have received treatments. The investigators will be masked during analysis.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Early Childhood Development

Model Details: Longitudinal, randomized-control trial with stepped-wedge research design

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 20, 2022
• Study Start: June 15, 2021
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)