NCT07489079

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Provider Self-Efficacy

    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

    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

    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 Outcomes (5)

  • Provider Job Stress

    Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)

  • Caregiver-Child Interaction Quality: Adult Behavior

    Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)

  • Caregiver-Child Interaction Quality: Child Behavior

    Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)

  • Classroom Quality

    Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)

  • Provider-Rated Acceptability, Appropriateness, and Feasibility of Intervention

    Post-Intervention Session (Day 1 up to Day 30, approximately)

Study Arms (1)

FCC Providers + Assistants

EXPERIMENTAL

Family child care providers and their assistants.

Behavioral: PlayReadVIP

Interventions

PlayReadVIPBEHAVIORAL

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.

FCC Providers + Assistants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Less than 18 years old
  • Does not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Alan Mendelsohn, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations