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Clinical Trials/NCT05198739
NCT05198739
Completed
N/A

Feasibility Study of the Pilot Implementation of the Video Interaction Project in Brazil

NYU Langone Health1 site in 1 country32 target enrollmentFebruary 5, 2022
ConditionsParenting

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
NYU Langone Health
Enrollment
32
Locations
1
Primary Endpoint
Change in Parenting practices in Cognitive stimulation
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

This international study will be conducted in Southern Brazil. After translation and cultural adaptation of VIP materials (Aim 1), a qualitative investigation of VIP implementation feasibility (Aim 2) will be conducted using semi-structured interviews and observation of engagement for approximately 50 caregiver-child dyads with children 0-5 years who will participate in 3 VIP sessions. To explore changes in parenting and child outcomes (Aim 3), dyads enrolled in the study (for Aim 2) will complete assessments pre- and post-participation in 3 VIP sessions.

Registry
clinicaltrials.gov
Start Date
February 5, 2022
End Date
March 3, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Parenting practices in Cognitive stimulation

Time Frame: Baseline Visit, Visit 4 (7 months)

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)

Changes in Parent-child interactions during reading

Time Frame: Baseline Visit, Visit 4 (7 months)

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)

Change in Parent Reading Belief of their children

Time Frame: Baseline Visit, Visit 4 (7 months)

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.

Change in the Percentage of Acceptance of the Video Interaction Project

Time Frame: Baseline Visit, Visit 4 (7 months)

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.

Secondary Outcomes

  • Change in Depression in Caregivers(Baseline Visit, Visit 4 (7 months))
  • Child Development (CS)(Baseline Visit, Visit 4 (7 months))
  • Change in Stress in Caregivers(Baseline Visit, Visit 4 (7 months))

Study Sites (1)

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