Parenting Support for Child Development and Mental Health

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the Video Interaction Project (VIP) can enhance child development and mental health in Flint, Michigan, following the Flint Water Crisis. It supports parents in engaging in activities like pretend play and shared reading with their infants during pediatric visits. Families with infants receiving care at Hurley Children's Clinic who are three months old or younger may be eligible to join. The trial seeks ways to better support young children's development in communities facing significant challenges. As an unphased trial, it offers families the opportunity to contribute to innovative solutions for child development in challenging environments.

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 prior data suggests that the Video Interaction Project is safe for enhancing child development and mental health?

Research shows that the Video Interaction Project (VIP) supports child development and parenting. Studies have found that VIP uses video feedback during regular doctor visits to encourage positive parenting activities like reading and playing, which are important for a child's growth.

Regarding safety, VIP is generally safe because it involves non-invasive interactions between parents and children. Past experiences with VIP indicate no physical risks, as it is based on educational and supportive activities. No reports of harmful effects have emerged from participating in this program. Overall, the focus remains on enhancing positive parenting without introducing risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Video Interaction Project (VIP) because it offers a fresh approach to supporting child development and mental health. Unlike traditional treatments that might involve medication or therapy sessions, VIP is a family-centered program integrated into routine pediatric well-child visits. It uniquely focuses on promoting positive parenting practices, such as pretend play, shared reading, and daily routines, which can enhance the parent-child relationship and foster healthy development. This strengths-based intervention empowers parents to actively participate in their child's growth, potentially leading to more lasting and impactful outcomes.

What evidence suggests that the Video Interaction Project is effective for enhancing child development and mental health?

Research shows that the Video Interaction Project (VIP), which participants in this trial may receive, effectively supports children's development and mental health. Studies have found that children in VIP are more likely to develop normally, and their parents experience less stress. The program enhances parent-child interactions by encouraging activities like pretend play and reading together during doctor visits. By promoting positive parenting, VIP reduces parental stress and improves children's outcomes. Early results also suggest that implementing this program remotely can enhance children's mental health, making it adaptable to various settings. ^{2 6 7 8 9}

Who Is on the Research Team?

Alan Mendelsohn, MD

Principal Investigator

New York Langone Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3083927/

Use of Videotaped Interactions During Pediatric Well-Child ... Results. VIP was associated with lower levels of parenting stress. VIP children were more likely to have normal cognitive development and less likely to have ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4847426/

Impacts of the Video Interaction Project on Parenting Stress Results indicated that VIP, a preventive intervention targeting parent-child interactions, is associated with decreased parenting stress.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163638324000870

Effects of a video-feedback intervention on parenting ... This single-cohort, multicentric study aims to evaluate the efficacy of early video-feedback intervention (VFI) in improving maternal parenting behaviors.

4. researchprotocols.org researchprotocols.org/2024/1/e54619/

Remotely Delivered Video Interaction Guidance for ... Remote family interventions could be an effective ... Video interaction guidance (VIG) has shown promise for improving child mental health.

5. preventionservices.acf.hhs.gov preventionservices.acf.hhs.gov/programs/913/show

Video Interaction Project The Video Interaction Project (VIP) aims to use regularly scheduled pediatrician visits for children ages 0–5 to support child development, school readiness ...

6. 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.

7. publications.aap.org publications.aap.org/pediatrics/article/148/2/e2021052582/179805/Preventing-Childhood-Toxic-Stress-Partnering-With

Preventing Childhood Toxic Stress: Partnering With ... Enhancing parent talk, reading, and play in primary care: sustained impacts of the video interaction project . J Pediatr . 2018. ;. 199. : 49.

8. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-025-02494-6

The use of video feedback to promote developmentally ... This study tests a video-feedback intervention (VFI) with parents of young children at risk of ASD.

9. researchgate.net researchgate.net/publication/6272334_Use_of_Videotaped_Interactions_During_Pediatric_Well-Child_Care_Impact_at_33_Months_on_Parenting_and_on_Child_Development

Impact at 33 Months on Parenting and on Child Development We performed a randomized, controlled trial to assess the impact of the Video Interaction Project (VIP), a program based in pediatric ...