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Caregiver Support Program for Child Development

N/A
Waitlist Available
Research Sponsored by RTI International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult pregnant women
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether a program to help caregivers rear their children under age 5 will improve child development outcomes. The study will follow three cohorts of villages in Cambodia over 12 months, collecting data four times.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves educational and behavioral interventions rather than medical treatments, traditional side effects are not applicable. However, there may be indirect impacts on family dynamics or caregiver stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult and currently pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver Report of Early Development Index (CREDI Instrument) - Child Development
Early Childhood Development Indicators (ECDI Instrument) - Child Development
Secondary outcome measures
Integrated Early Childhood Development Caregiving Key Behaviors (ECDI Instrument)
WHO Minimum Dietary Diversity-Women (MDD-W) Instrument
WHO Prevalence of Exclusive Breastfeeding Instrument (children aged 0-6 months)
+1 more

Trial Design

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 Location

Who is running the clinical trial?

RTI InternationalLead Sponsor
188 Previous Clinical Trials
872,464 Total Patients Enrolled
United States Agency for International Development (USAID)FED
202 Previous Clinical Trials
1,473,944 Total Patients Enrolled

Media Library

IECD Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05197985 — N/A
Child Development Research Study Groups: Integrated Early Childhood Development Intervention, Control Arm
Child Development Clinical Trial 2023: IECD Intervention Highlights & Side Effects. Trial Name: NCT05197985 — N/A
IECD Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05197985 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research available to participants?

"Clinicaltrials.gov reveals that this study, which began on June 15th 2021, is no longer actively recruiting candidates. However, 59 other trials are currently seeking out participants for their studies."

Answered by AI

What are the key aims of this trial?

"The primary outcome of this research, monitored for up to a year, is the Caregiver Reported Early Development Index (CREDI Instrument) - Child Development. Secondary objectives include measuring caregiving practices with the Integrated Early Childhood Development Caregiving Key Behaviours (ECDI Instrument), as well as evaluating nutritional status through two World Health Organization instruments: Minimum Acceptable Diet Instrument for children aged 6-23 months and Minimum Dietary Diversity-Women (MDD-W). Scores on these measures range from 0 to 38/8/26 respectively; higher scores indicate better outcomes."

Answered by AI
~894 spots leftby May 2025