Caregiver Support Program for Child Development

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RTI International

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if altering caregiver practices can enhance young children's development. The focus is on caregivers in Cambodia, specifically in the Kampong Thom and Preah Vihear provinces. Participants will either receive a new support program (IECD Intervention) or be in a group without additional assistance, allowing researchers to compare outcomes. This trial suits adults caring for children under five or pregnant women in these areas. Running until 2025, the trial will collect data at several points to track progress. As an unphased trial, it offers a unique opportunity to contribute to valuable research that could improve child development strategies in the community.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on caregiver support for child development, so it's unlikely that medication changes are required.

What prior data suggests that this program is safe for caregivers and children?

Research has shown that early childhood development programs, like the one in this study, are generally safe. Studies on similar programs have not found any serious side effects. These programs typically aim to improve parenting skills and support children's development, and participants handle them well.

For instance, parenting programs have effectively supported child development without harming caregivers or children. This trial focuses on data collection and observation, not testing a new treatment. The safety record of similar programs should provide confidence. Overall, joining this program is expected to be safe for both caregivers and their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Early Childhood Development (IECD) Intervention because it focuses on supporting caregivers, which is a unique approach compared to traditional treatments that typically concentrate solely on direct child interventions. This program emphasizes the holistic development of children by empowering parents and caregivers with knowledge and skills, potentially offering a more sustainable and impactful improvement in child development outcomes. Unlike conventional methods that might not engage caregivers as actively, the IECD Intervention aims to create a nurturing environment from the ground up, which could lead to long-term benefits for children's growth and development.

What evidence suggests that the IECD Intervention is effective for improving child development outcomes?

Research has shown that the Integrated Early Childhood Development (IECD) program, which participants in this trial may receive, helps improve child development. One study used the Ages and Stages Questionnaire (ASQ-3) to measure this and found positive results. Another study in rural China found that the IECD program also improved caregivers' mental health and enhanced family life. Early programs like IECD are important because they provide lasting benefits for children's growth and future learning. These findings suggest that the IECD program could significantly enhance child development in similar communities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Integrated Early Childhood Development Intervention Experimental Treatment 1 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 Arm Active Control 1 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+).

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40506265/

The Impact of an Integrated Nurturing Care Intervention to ... The study primary outcome, early childhood development, was measured using the Ages and Stages Questionnaire (ASQ-3) and the Global Scales for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29429198/

Effectiveness of Integrated Early Childhood Development ... Conclusions: The IECD intervention strategy implemented in rural China effectively improved the mental health of caregivers, optimizes families' ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1875957225001044

Effectiveness of early intervention and prediction ... This study underscores the effectiveness of early intervention services in Taiwan. Consistent reassessments may facilitate subsequent educational interventions.

4. gh.bmj.com gh.bmj.com/content/7/6/e008926

Priority setting in early childhood development This paper presents a unified analytical framework to address this need and highlights the rather remarkable range in both costs and cost-effectiveness.

5. blogs.worldbank.org blogs.worldbank.org/en/education/Comprehensive-early-childhood-interventions-to-build-human-capital

Comprehensive early childhood interventions to build ... The findings highlight the importance of early investments in shaping long-term outcomes and provide insights for policymakers and practitioners ...

6. ectacenter.org ectacenter.org/eco/pages/childoutcomes.asp

Child Outcomes The three child outcomes are: Positive Social-Emotional Skills, Acquisition and Use of Knowledge and Skills, and Use of Appropriate Behaviors to Meet Needs.

7. odphp.health.gov odphp.health.gov/healthypeople/priority-areas/social-determinants-health/literature-summaries/early-childhood-development-and-education

Early Childhood Development and Education This summary of the literature on Early Childhood Development and Education as a social determinant of health is a narrowly defined examination.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8109838/

Parenting interventions to promote early child development ... We conducted a global systematic review and meta-analysis to evaluate the effectiveness of parenting interventions on ECD and parenting outcomes.

9. ed.gov ed.gov/sites/ed/files/about/inits/ed/earlylearning/files/integration-of-early-childhood-data.pdf

The Integration of Early Childhood Data (PDF) Through an ECIDS, EC programs can share data related to the children and families the program serves, personnel, and the characteristics of the program or ...

10. archive.cdc.gov archive.cdc.gov/www_cdc_gov/policy/hi5/earlychildhoodeducation/index.html

Early Childhood Education | Health Impact in 5 Years | OPPE ECE programs improve child development, act as a protective factor against adult disease, and improve academic, cognitive, and social-emotional ...