Caregiver-Child InteractionNCT07489079
PlayReadVIP in Family Child Care
A study testing PlayReadVIP in people with Caregiver-Child Interaction and Child Learning, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver-Child Interaction, Child Learning
- What is being tested?
- PlayReadVIP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years old
- Does not speak English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: 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.
- Conditions
- Caregiver-Child Interaction, Child Learning
- Being tested
- PlayReadVIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlayReadVIPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FCC Providers + Assistants | Experimental | Family child care providers and their assistants. Receives: Behavioral: PlayReadVIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
Secondary outcomes (5)
Provider Job Stress
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.
Measured: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
Caregiver-Child Interaction Quality: Adult Behavior
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.
Measured: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
Caregiver-Child Interaction Quality: Child Behavior
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.
Measured: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
Classroom Quality
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.
Measured: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)
Provider-Rated Acceptability, Appropriateness, and Feasibility of Intervention
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.
Measured: Post-Intervention Session (Day 1 up to Day 30, approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start27 May 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver-Child InteractionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Mendelsohn, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489079
- Sponsor's protocol ID
- 25-00532
- Status last verified
- May 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the PlayReadVIP Intervention to the Family Child Care (FCC) Environment
- ClinicalTrials.gov ID
- NCT07489079
- Acronym / sponsor ID
- 25-00532
- Conditions
- Caregiver-Child Interaction, Child Learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FCC Providers + Assistants | Experimental | Behavioral: PlayReadVIPFamily child care providers and their assistants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Less than 18 years old
- Does not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlayReadVIPPlayReadVIP (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. | Behavioural | FCC Providers + Assistants |
Primary outcome
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.
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.
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.
5 secondary outcomes
Provider Job Stress
Time frame: 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)
Caregiver-Child Interaction Quality: Child Behavior
Time frame: 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)
Provider-Rated Acceptability, Appropriateness, and Feasibility of Intervention
Time frame: Post-Intervention Session (Day 1 up to Day 30, approximately)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Mendelsohn, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlayReadVIP in people with Caregiver-Child Interaction and Child Learning, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Mazzuchelli (917-890-1073, Denise.Mazzuchelli@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Self-Efficacy (time frame: Pre-Intervention (Baseline), Post-Intervention Session (Day 1 up to Day 30, approximately)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.