NCT05198739

Brief Summary

Early exposure to poverty is associated with adverse impacts on long-term educational achievement. Support of positive parenting is a key strategy to prevent emergence of socioeconomic disparities in child development. This study will assess the feasibility of the pilot implementation of an evidence-based parenting program designed to prevent disparities in child development, the Video Interaction Project (VIP), in Brazil, as an exemplar low- and middle-income country (LMIC), and explore changes in parenting and child outcomes after participation in the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 10, 2021

Last Update Submit

December 4, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in the Percentage of Acceptance of the Video Interaction Project

    Semi-structured interviews (approximately 40-60 min) conducted. Caregivers will share their opinions about activities, provided materials, barriers/facilitators to participation and use of intervention strategies in the home. Interviews will be audio recorded, transcribed, and translated from Brazilian Portuguese to English. Guides for the semi structured interviews have been developed based on previous studies and theoretical frameworks.

    Baseline Visit, Visit 4 (7 months)

  • Change in Parenting practices in Cognitive stimulation

    StimQ - Infant survey will be used to evaluates reading, teaching, responsivity with the caregivers through a video call. The survey consist of 4 subscales, which are summed together for a total score (StimQ2-I range 0-42)

    Baseline Visit, Visit 4 (7 months)

  • Changes in Parent-child interactions during reading

    Adult-Child Interactive Reading Inventory (ACIRI) assesses both adult and child behaviors in three categories that research has identified as critical: Enhancing Attention to Text, Promoting Interactive Reading and Supporting Comprehension, and Using Literacy Strategies. An observational measure where caregivers and children are observed and given an score (3 = most of the time, 2 =some of the time , 1 = infrequently, 0= not at all)

    Baseline Visit, Visit 4 (7 months)

  • Change in Parent Reading Belief of their children

    The Parent Reading Belief Inventory (PRBI) is a self-reporting instrument that assess parents' beliefs about the frequency, quality, and importance of their child's literacy activities. The 42-item instrument provides seven subscales: positive affect, verbal participation, resources, teaching efficacy, knowledge base, environmental input, and reading instruction.

    Baseline Visit, Visit 4 (7 months)

Secondary Outcomes (3)

  • Change in Depression in Caregivers

    Baseline Visit, Visit 4 (7 months)

  • Change in Stress in Caregivers

    Baseline Visit, Visit 4 (7 months)

  • Child Development (CS)

    Baseline Visit, Visit 4 (7 months)

Study Arms (1)

Video Interaction Project (VIP) Group

EXPERIMENTAL

Parent-Child dyads will participate in a Video Interaction Project to encourage parenting practices/relationships and child development by promoting positive parenting practices.

Other: Video Interaction Project (VIP) program

Interventions

Video Interaction Project (VIP) is a strengths-based, family-centered intervention designed to enhance parenting practices/relationships and child development by promoting positive parenting practices such as pretend play, shared reading, and daily routines. In VIP's core component, a VIP coach video-records the parent / child for 3-5 minutes playing/reading with a provided toy and/or book, then reviews the video with the parent to facilitate self-reflection on the interaction and identifies and reinforces strengths. In the US, VIP is delivered in the context of pediatric primary care visits, with a COVID-19 remote adaptation (see Section 6 for details). Research staff will delivery VIP through video calls with subjects in Brazil.

Video Interaction Project (VIP) Group

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver-child dyads with at least one child age 0 to 5 years;
  • Caregiver can be contacted (has a working phone); and
  • Caregiver is 18 years old or older.
  • Child is 1 day to 5 years old

You may not qualify if:

  • Caregiver is under 18 years old; and
  • Child has a neurodevelopmental disability or known or suspected genetic syndrome

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

Study Design

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

Study Record Dates

First Submitted

December 10, 2021

First Posted

January 20, 2022

Study Start

February 5, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Alan.Mendelsohn@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations