Video Interaction Project in Brazil

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

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.

Study Overview

• Status: Completed
• Conditions: Parenting
• Intervention / Treatment: Other: Video Interaction Project (VIP) 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression in Caregivers	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."	Baseline Visit, Visit 4 (7 months)
Change in Stress in Caregivers	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.	Baseline Visit, Visit 4 (7 months)
Child Development (CS)	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.	Baseline Visit, Visit 4 (7 months)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20-00057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No