- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489079
PlayReadVIP in Family Child Care
May 28, 2026 updated by: NYU Langone Health
Adaptation of the PlayReadVIP Intervention to the Family Child Care (FCC) Environment
This study uses a mixed-methods, single-group pretest-posttest design to evaluate (1) implementation outcomes (acceptability, adoption, fidelity) and (2) preliminary changes associated with delivery of the adapted PlayReadVIP intervention in Family Care Center (FCC) settings.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Denise Mazzuchelli
- Phone Number: 917-890-1073
- Email: Denise.Mazzuchelli@nyulangone.org
Study Contact Backup
- Name: Jade Turbides
- Phone Number: 917-890-1073
- Email: Jade.turbides@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age or older
- Family childcare provider or assistant in MARC Network who cares for children who are 0-5 years of age
- English or Spanish-speaking
Exclusion Criteria:
- Less than 18 years old
- Does not speak English or Spanish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FCC Providers + Assistants
Family child care providers and their assistants.
|
PlayReadVIP (formerly the Video Interaction Project) is an intervention that uses a strengths-based reflective-practice model to coach parents on positive parenting interactions with their children during book reading and play.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Provider Self-Efficacy
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
Provider self-efficacy is measured using the Beliefs About Parent Support for Early Literacy Scale (BPSES).
The BPSES consists of items assessing providers' confidence in managing children's behavior and supporting children's development.
Items are rated on a 5-point Likert scale ranging from Strongly disagree to Strongly agree.
The total score is calculated by summing all five items, and ranges from 5 to 25, with higher scores indicating greater provider self-efficacy.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
|
Provider Perceptions of Children's Literacy Practices
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
The Provider Perception survey was developed by the NYULH PlayReadVIP research team and includes frequency-based items assessing how often children in the provider's care engage in literacy-related behaviors, social interaction, communication, sustained attention during reading, and challenging behaviors.
Each item is rated on a 10-point Likert scale from 0-9.
The total score is the sum of responses and ranges from 0-72, with higher scores indicating greater frequency of the specified behaviors.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
|
Cognitive Stimulation in the Caregiving Environment
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
The StimQ-2 is a standardized, validated caregiver-report measure designed to assess the quality and frequency of cognitive stimulation activities provided to children in early childcare settings.
The instrument includes 5-point Likert scale from 0-5 across multiple domains, including shared reading practices, caregiver teaching activities, verbal responsiveness, and availability of developmentally appropriate learning materials.
The highest total StimQ Score is 39 and the lowest is 0. Higher scores indicate greater provision of cognitive stimulation within the caregiving environment.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Provider Job Stress
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
The Child Care Worker Job Stress Inventory (CCW-JSI) is a survey that includes items drawn from three domains: job demands, job resources, and job control.
Items are rated on a 5-point frequency scale ranging from 1-5; the total score is calculated as the sum of item responses and ranges from 51 to 255; higher scores indicate greater provider-reported job stress.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
|
Caregiver-Child Interaction Quality: Adult Behavior
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
Adult Child Interactive Reading Inventory (ACIRI) is an observational measure that assesses adult behaviors across multiple domains, including enhancing children's attention to text, promoting interactive reading and supporting comprehension, and use of literacy-supporting strategies.
Each item is rated on a scale from 0-3; the total score is the average of all responses and ranges from 0-3, with higher scores indicating greater caregiver-child interactions.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
|
Caregiver-Child Interaction Quality: Child Behavior
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
Adult Child Interactive Reading Inventory (ACIRI) is an observational measure that assesses adult behaviors across multiple domains, including enhancing children's attention to text, promoting interactive reading and supporting comprehension, and use of literacy-supporting strategies.
Each item is rated on a scale from 0-3; the total score is the average of all responses and ranges from 0-3, with higher scores indicating greater caregiver-child interactions.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
|
Classroom Quality
Time Frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
The Climate of Healthy Interactions for Learning and Development (CHILD) is a standardized observational measure that includes structured observation of classroom practices across nine domains, including transitions, directions and rules, social and emotional learning, adult awareness, adult affect, adult cooperation, adult-child interactions, individualized and developmentally appropriate practices, and child behaviors.
The measure consists of 28 easily observable items, scored on a 5-point anchored Likert scale ranging from -2 (very undermining) to +2 (very promoting).
The score range is then -2 to +2, with higher score indicating more promoting behavior.
|
Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
|
|
Provider-Rated Acceptability, Appropriateness, and Feasibility of Intervention
Time Frame: Post-Intervention Session (Day 1 up to Day 30, approximately)
|
After completing all the intervention sessions (up to 3), the provider completes a Provider/Assistant Feedback survey developed by the NYULH PlayReadVIP research team, assessing the acceptability of the intervention.
Each item is rated on a 10-point Likert scale from 0-9.
The total score ranges from 0-99; higher scores indicate greater overall acceptability of the intervention.
|
Post-Intervention Session (Day 1 up to Day 30, approximately)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan Mendelsohn, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
March 17, 2026
First Submitted That Met QC Criteria
March 17, 2026
First Posted (Actual)
March 23, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 25-00532
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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