Parenting Intervention for Child Development

(RTG Trial)

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Male, Past third trimester, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a unique program designed to support low-income mothers and their babies during the first three years of life. The program offers regular sessions with a social worker, essential baby items, and connections to community resources, aiming to prepare children for school. It compares the impact of these services on mothers who receive them versus those who do not. Expecting mothers in their third trimester who need support and meet low-income criteria may find this trial suitable. As an unphased trial, it provides a valuable opportunity for mothers to access resources that can positively impact their child's early development.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on parenting support rather than medical treatment, so it's unlikely that medication changes are required.

What prior data suggests that this parenting intervention is safe for child development?

Research has shown that the Room to Grow program is safe and well-received by participants. Studies highlight its positive effects on families, particularly by providing essential items and support for child development. No negative effects have been reported, indicating safety for both parents and children. The program supports families through regular meetings with a social worker and provides necessary baby items, which helps reduce stress and improve family well-being. Overall, evidence suggests that Room to Grow is a safe and helpful program for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parenting Intervention for Child Development because it provides a holistic approach to supporting new mothers, unlike many current parenting programs that might only offer advice or educational materials. This intervention includes personalized, one-on-one sessions with an expert clinical social worker every three months, which allows for tailored guidance and support. Additionally, the provision of essential baby items and equipment addresses practical needs, potentially improving both maternal and child well-being in a comprehensive manner. This blend of social, practical, and emotional support over an extended period is what sets it apart and holds promise for enhancing child development outcomes.

What evidence suggests that this parenting intervention is effective for child development?

This trial will compare the effects of the Room to Grow program with a control group. Research has shown that Room to Grow positively impacts important outcomes. Participants in the intervention group will receive Room to Grow services, including regular one-on-one meetings with social workers and essential baby items to reduce financial stress for families. Studies have found that families in this program have more books and developmental items at home, which are crucial for child development. These elements help parents create a more supportive environment for their children. By addressing both emotional and material needs, Room to Grow increases the likelihood of children being ready for school. This comprehensive support is backed by research showing that parenting programs can improve early child development outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Christopher Wimer, PhD

Principal Investigator

Senior Research Scientist at CPRC, School of Social Work

Are You a Good Fit for This Trial?

This trial is for low-income women at least 16 years old who are in their third trimester of pregnancy (weeks 28-34) and have not yet given birth. Participants must meet Room to Grow's program criteria and be in need of services. Men, those unable to read/write English or Spanish, past the third trimester, or from mid to high income are excluded.

Inclusion Criteria

In need of services

I am in my third trimester of pregnancy (weeks 28-34).

I am female.

Exclusion Criteria

I am male.

Mid to high income

Cannot read/write English and/or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive Room to Grow services, including one-on-one sessions with a clinical social worker every three months and provision of essential baby items and equipment

3 years

In-person sessions every 3 months, ongoing communication via phone and email

Follow-up

Participants are monitored for long-term outcomes, including cognitive and socioemotional development of children

42-72 months after birth of child

In-person follow-up meetings

What Are the Treatments Tested in This Trial?

Interventions

• Child Development
• Parenting

Trial Overview The trial tests an innovative program called Room to Grow (RtG), aimed at enhancing child development and parenting skills among families living in poverty. It involves one-on-one sessions with social workers every three months, continuous support via communication channels, provision of baby essentials, and access to community resources over a three-year period.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

The treatment group will consist of 160 mothers who were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby through a combination of one-on-one sessions with an expert clinical social worker in-person every three months and provision of essential baby items and equipment.

Group II: Control Group Active Control 1 Intervention

The control group will consist of 160 mothers who will not receive Room to Grow services.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8208596/

Early Impacts of Room to Grow: A Multifaceted Intervention ... The study finds that early impacts on proximal outcomes are uniformly positive, especially with regards to the presence of books and developmental goods in the ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04226053

NCT04226053 | Room to Grow Evaluation for Children The goal of Room to Grow's innovative program is to help parents increase the probability that their children will enter school ready to learn and continue on ...

3. researchgate.net researchgate.net/publication/351620031_Early_Impacts_of_Room_to_Grow_A_Multifaceted_Intervention_Supporting_Parents_and_Children_Age_Zero_to_Three

Early Impacts of Room to Grow: A Multifaceted Intervention ... The study finds that early impacts on proximal outcomes are uniformly positive, especially with regards to the presence of books and ...

4. 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.

5. worldprojects.columbia.edu worldprojects.columbia.edu/news-media/columbia-world-projects-room-grow-kick-partnership-support-parents

Columbia World Projects & Room to Grow Kick Off Partnership ... The model offers structured coaching and community connections to support parents during the first three years of their children's lives, as ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jftr.12549

Routines and child development: A systematic review Findings mainly indicate that routines are associated with positive developmental outcomes in children, covering cognitive, self-regulation, ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/10848223241299107

Infant Home Safety Programs for Parents to Prevent Injuries This study systematically reviewed studies implementing infant home safety intervention programs for parents. The findings revealed that infant ...