Parenting Support for Child Development and Mental Health

Recruiting at 1 trial location

Overseen By Caitlin Canfield, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Low birth weight, Non-singleton birth, Genetic syndrome, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months to 4 years

486 Participants Needed

Trial Summary

What is the purpose of this trial?

Public health disasters have disproportionate impacts on low income communities, through pathways that add to those of poverty and associated stressors, and act over extended periods. Very young children are highly vulnerable to long-term impacts on development and mental health in the context of parenting challenges following disasters, yet frequently receive the least attention and resources. This study will test the role of universal parenting support in enhancing young children's development and mental health in Flint, Michigan following the Flint Water Crisis.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Video Interaction Project (VIP) for child development and mental health?

Research shows that the Video Interaction Project (VIP) can improve early child development and responsive parenting, especially in families with children at risk of developmental delays. Studies have found that VIP has a moderate impact on cognitive and language development in children whose mothers have some high school education, and it enhances positive parenting and child outcomes in various settings. ^{1 2 3 4 5}

Is the Video Interaction Project (VIP) safe for use in parenting support programs?

The Video Interaction Project (VIP) and similar programs like VIPP-SD have been tested in multiple studies with parents and children, showing positive effects on parenting and child development without any reported safety concerns. ^{1 3 4 6 7}

How is the Video Interaction Project (VIP) treatment different from other treatments for child development and mental health?

The Video Interaction Project (VIP) is unique because it uses real-time video feedback of parent-child interactions to enhance responsive parenting, which is not a common approach in other treatments. This method focuses on improving early relational health by directly showing parents how their interactions with their child can be more effective, making it distinct from traditional therapies that may not use video feedback. ^{1 3 6 8 9}

Research Team

Alan Mendelsohn, MD

Principal Investigator

New York Langone Medical Center

Eligibility Criteria

This trial is for infants under three months old receiving care at Hurley Children's Clinic in Flint, Michigan. Caregivers must have a working phone and plan to stay in the area for at least 3 years. Infants with very low birth weight, multiple births, or significant medical conditions are excluded.

Inclusion Criteria

Infant is receiving pediatric care at Hurley Children's Clinic

My baby is 3 months old or younger.

My caregiver can be reached by phone.

Exclusion Criteria

My guardian does not have a condition that makes communication difficult.

Parent/legal guardian has previously participated in VIP intervention with another child

Not planning to stay in Flint area for at least 3 years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive strengths-based parenting support through the Video Interaction Project (VIP) during pediatric well-child visits to enhance parenting practices and child development.

6 months to 4 years

Follow-up

Participants are monitored for child development and parenting practices through various assessments and surveys.

6 months to 4 years

Treatment Details

Interventions

• Video Interaction Project

Trial Overview The study tests how universal parenting support can help young children's development and mental health after the Flint Water Crisis. It involves caregivers interacting with their infants through a program called Video Interaction Project.

Participant Groups

Group I: Video Interaction Project Experimental Treatment 1 Intervention

VIP is a strengths-based, family-centered intervention that uses pediatric well-child visits to enhance parenting practices/relationships and child development by promoting positive parenting practices such as pretend play, shared reading, and daily routines.

Group II: Control Active Control 1 Intervention

Care as usual

Video Interaction Project is already approved in United States for the following indications:

Approved in United States as Video Interaction Project for:

• Supporting child development and school readiness in children aged 0-5

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The study implemented Video Intervention Therapy (VIT) to enhance Parental Reflective Functioning (PRF) in caregivers of children hospitalized for severe psychiatric issues, showing that the intervention was feasible and well-accepted by participants and therapists.

With a compliance rate of 85% in the VIT group and positive indications for improving both parental and child mental health outcomes, this pilot study supports the need for a larger randomized control trial to further evaluate VIT's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. Leyton, F., Olhaberry, M., Morán, J., et al.[2021]

The Video Interaction Project (VIP) showed a moderate positive impact on cognitive and language development in Latino children at risk of developmental delay, particularly for those whose mothers had between seventh and 11th grade education, with effect sizes of approximately 0.75 SD for cognitive development and 0.5 SD for expressive language.

However, the program had little to no impact on children whose mothers had sixth grade or lower education, indicating that maternal education level plays a significant role in the effectiveness of the VIP intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. Mendelsohn, AL., Dreyer, BP., Flynn, V., et al.[2021]

The Video Interaction Project (VIP) significantly improved parenting practices and reduced parenting stress among 99 Latino children at risk of developmental delays, indicating its effectiveness in promoting early child development.

Children who participated in VIP were more likely to achieve normal cognitive development and less likely to experience developmental delays compared to those in the control group, highlighting the program's positive impact on at-risk preschoolers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of videotaped interactions during pediatric well-child care: impact at 33 months on parenting and on child development. Mendelsohn, AL., Valdez, PT., Flynn, V., et al.[2021]

References

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

Supporting responsive parenting in real-world implementation: minimal effective dose of the Video Interaction Project. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. [2021]

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

Working with Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD): A case study. [2021]

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

Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Video feedback compared to treatment as usual in families with parent-child interactions problems: a randomized controlled trial. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pairing attachment theory and social learning theory in video-feedback intervention to promote positive parenting. [2022]

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

Use of videotaped interactions during pediatric well-child care: impact at 33 months on parenting and on child development. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The efficacy of VIPP-V parenting training for parents of young children with a visual or visual-and-intellectual disability: a randomized controlled trial. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The effectiveness of VIPP-V parenting training for parents of young children with a visual or visual-and-intellectual disability: study protocol of a multicenter randomized controlled trial. [2019]