3500 Participants Needed

Caregiver Support Program for Child Development

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: RTI International
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adult caregivers aged 18 or older of children under the age of 5, as well as pregnant women in Cambodia. It's focused on improving child development outcomes by changing caregiving practices.

Inclusion Criteria

I am an adult caring for a child under 5 years old.
I am an adult and currently pregnant.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data is collected from all cohorts before any intervention begins

4 weeks
1 visit (in-person)

Intervention

Implementation of the Integrated Early Childhood Development Activity interventions in three cohorts sequentially

36 months
Bi-weekly group sessions and individualized home visits

End Line Data Collection

Data collection at the end of each cohort's intervention period

4 weeks per cohort
1 visit (in-person) per cohort

Follow-up

Participants are monitored for long-term outcomes and sustainability of behavior changes

12 months

Treatment Details

Interventions

  • IECD Intervention
Trial Overview The study tests an Integrated Early Childhood Development (IECD) intervention across two provinces in Cambodia. It uses a stepped-wedge design to introduce interventions sequentially in three cohorts and measures changes with internationally validated tools over four years.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Early Childhood Development InterventionExperimental Treatment1 Intervention
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+).
Group II: Control ArmActive Control1 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+).

Find a Clinic Near You

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials
201
Recruited
942,000+

United States Agency for International Development (USAID)

Collaborator

Trials
212
Recruited
1,519,000+
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