HealthySteps + PlayReadVIP for Pediatric Care

Overseen By Janae Kuttamperoor

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Non-singleton child, Severe impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist parents and their infants by combining two programs: HealthySteps, which provides parenting support, and PlayReadVIP, which uses video coaching to strengthen parent-child relationships. Researchers aim to determine how well this combined method works compared to using only HealthySteps. The study examines the impact of these programs on parenting, parent-child bonds, and child development. Families with infants under 6 months old who face challenges, such as past difficult experiences or parenting struggles, may be suitable participants. Participants should speak English or Spanish to fully engage.

As an unphased trial, this study offers families a unique opportunity to contribute to innovative research that could enhance parenting support and child development strategies.

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 parenting support and child development, so it's best to ask the trial coordinators for more details.

What prior data suggests that the HealthySteps + PlayReadVIP model is safe for pediatric care?

Research has shown that both HealthySteps and PlayReadVIP are safe and well-liked programs. HealthySteps supports children's growth, particularly in motor and social skills. Parents report positive experiences with the program, and no major safety issues have emerged.

For PlayReadVIP, studies indicate it enhances parent-child interactions. It promotes more responsive parenting, benefiting child development. No negative effects have been reported from participating in PlayReadVIP sessions.

Both programs aim to improve parenting and child relationships, which typically carry very low risk. Overall, evidence suggests these programs are safe and well-received by families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HealthySteps + PlayReadVIP program because it combines traditional parenting support with innovative video coaching to enhance relational health. Unlike standard HealthySteps, which focuses solely on parenting guidance, this new approach integrates PlayReadVIP, a video-based tool that helps parents and children improve their relationship through interactive play and reading activities. This dual approach aims to foster stronger parent-child bonds and promote healthier developmental outcomes, offering a potentially more comprehensive solution than what's currently available.

What evidence suggests that the HealthySteps + PlayReadVIP model is effective for pediatric care?

Research has shown that the HealthySteps program, which participants in this trial may receive, effectively prevents negative outcomes for children and parents. It supports children's physical and emotional growth. In this trial, some families will receive the combined HealthySteps + PlayReadVIP approach. Studies on PlayReadVIP have demonstrated that just one session can lead to a 22% increase in parenting behaviors that support child well-being. Both components of this combined approach are backed by strong evidence, making them promising for improving parenting and child development. ^{1 2 3 5 6}

Who Is on the Research Team?

Caitlin Caitlin

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for families with young children receiving pediatric care. It's designed to see if combining two programs, HealthySteps and PlayReadVIP, can improve parenting support and child development compared to just HealthySteps alone.

Inclusion Criteria

Families must be identified as Tier 3 HealthySteps participants, indicating higher levels of need based on clinic screening for factors such as Adverse Childhood Experiences (ACEs) and parenting challenges or vulnerabilities

Parent is able and willing to provide consent for their own and their child's participation

My baby is 6 months old or younger.

Exclusion Criteria

Non-singleton child

Parent is unable to provide consent

Parent has plans to discontinue care at NYU Langone Health - Sunset Park Family Health Centers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families receive either the integrated HealthySteps + PlayReadVIP model or traditional HealthySteps

24 months

Regular visits as per pediatric primary care schedule

Follow-up

Participants are monitored for impacts on parenting, parent-child relationships, and child development

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HealthySteps + PlayReadVIP

Trial Overview The study compares traditional HealthySteps (HS) parenting support with an integrated model that adds PlayReadVIP video coaching. Families will be randomly assigned to one of the two groups to assess impacts on parenting, relationships, and child development.

How Is the Trial Designed?

Group I: HealthySteps + PlayReadVIP Experimental Treatment 2 Interventions

Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, plus PlayReadVIP, which promotes relational health through video coaching.

Group II: Standard HealthySteps Active Control 1 Intervention

Families (parent-child dyads) randomized to receive HealthySteps (HS), which provides parenting support, only.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A one-time webinar intervention for pediatric providers on patient-centered care showed a significant improvement in school functioning for children aged 8-12, with scores of 83.5 in the intervention group compared to 75.8 in the control group.

While the intervention was feasible and indicated some positive effects on health-related quality of life (HRQOL), further research is needed to evaluate its broader impact and to assess changes in provider knowledge before and after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of a One-Time Web-Based Provider Intervention on Patient-Reported Outcomes After the Well-Child Visit: A Feasibility Study. Coleman, CM., Alexander, GL., Barone, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06941337

Study Details | NCT06941337 | HealthySteps + PlayReadVIP This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) ...

2. withpower.com withpower.com/trial/phase-families-with-infants-4-2025-f16ce

HealthySteps + PlayReadVIP for Pediatric Care Research shows that the Healthy Steps program, a part of the treatment, has been effective in preventing negative outcomes for children and parents and ...

3. playreadvip.org playreadvip.org/news/findings-published-in-pediatric-research

New PlayReadVIP Findings Published in Pediatric Research! Results showed that a single visit was associated with a 22% increase in responsive parenting behaviors (behaviors shown to promote child ...

4. healthysteps.org healthysteps.org/resource/healthysteps-outcomes-summary/

HealthySteps Evidence Summary HealthySteps improves child health and well-being by supporting perceptual, motor and physical development, strengthening early social-emotional development.

5. nccp.org nccp.org/new-york/

New York PlayReadVIP (previously called Video Interaction Project or VIP), is an extensively-studied, evidence-based intervention designed for delivery in pediatric ...

6. inckmarks.org inckmarks.org/docs/7-15-2024/INCK%20MARKS%20DESCRIPTIONS%20AND%20SUMMARY%20FOR%20NASEM%20SCOPING%20REVIEW.pdf

exemplary and evidenced-based healthy parenting in The program combined home visits, parent group meetings, and pediatric care to support children's development and health up to age 3. Its ...