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

Trial Summary

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 data supports the effectiveness of the treatment 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 enhancing positive outcomes through early screening and family-centered care. ^{1 2 3 4 5}

How is the HealthySteps + PlayReadVIP treatment different from other pediatric care treatments?

The HealthySteps + PlayReadVIP treatment is unique because it integrates early child development specialists and enhanced developmental services into routine pediatric care, focusing on supporting both the physical and emotional development of young children and enhancing parental confidence in child-rearing. ^{1 4 5 6 7}

What is the purpose of this trial?

This study aims to investigate the effectiveness and implementation outcomes for the integration of two evidence-based practices and interventions (EBPIs) within pediatric primary care settings: HealthySteps (HS), which provides parenting support, and PlayReadVIP, which promotes relational health through video coaching. Families will be randomized to receive either the integrated HS + PlayReadVIP model or traditional HS, and investigators will examine impacts on parenting, parent-child relationships, and child development, as well as feasibility, acceptability, and appropriateness of the integrated intervention.

Research Team

Caitlin Caitlin

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Healthy Steps for Young Children program in pediatric residency training: impact on primary care outcomes. [2022]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Self-Reported Health Outcomes of Children and Youth with 10 Chronic Diseases. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Healthy Steps: resident's perceptions. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Healthy Steps: a systematic review of a preventive practice-based model of pediatric care. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Reshaping primary care: the Healthy Steps Initiative. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Early effects of the healthy steps for young children program. [2019]