Video Interaction Project in Brazil

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05198739
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
22.9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Video Interaction Project (VIP) program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility Study of the Pilot Implementation of the Video Interaction Project in Brazil
Actual Study Start Date :
Feb 2, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Video Interaction Project (VIP) Group

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in the Percentage of Acceptance of the Video Interaction Project [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.

  2. Change in Parenting practices in Cognitive stimulation [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)

  3. Changes in Parent-child interactions during reading [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)

  4. Change in Parent Reading Belief of their children [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.

Secondary Outcome Measures

  1. Change in Depression in Caregivers [Baseline Visit, Visit 4 (7 months)]

    The Edinburgh Postnatal Depression Scale (EPDS) is a questionnaire originally developed to assist in identifying possible symptoms of depression in the postnatal period.It is a 10-item questionnaire where women are asked to answer each question in terms of the past seven days. A score is calculated by adding the individual items for each question, the a score of 10 or above is commonly considered "possible depression."

  2. Change in Stress in Caregivers [Baseline Visit, Visit 4 (7 months)]

    The Perceived Stress Scale (PSS-10) is a 10-item questionnaire used to assess stress levels in young people and adults aged 12 and above. Respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. (Never = 0, Almost never = 1, Sometimes = 2, Fairly often = 3, Very often = 4).The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.

  3. Child Development (CS) [Baseline Visit, Visit 4 (7 months)]

    Development of the Dimensional Inventory of Child Development Assessment (IDADI) assess child development of children from zero to 72 months of age through parental reports covering Cognitive, Motor (Gross and Fine), Communication and Language (Receptive and Expressive), Socioemotional and Adaptive Behavior domains. A three-point Likert scale was established where: yes (2-points); sometimes (1-point) ; and no (0-point) to indicate if the skill was mastered.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1NYU Langone HealthNew YorkNew YorkUnited States10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Alan Mendelsohn, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05198739
Other Study ID Numbers:
  • 20-00057
First Posted:
Jan 20, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 8, 2022