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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FCC Providers + Assistants
Family child care providers and their assistants.
Behavioral: PlayReadVIP
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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