ParentingNCT05198739
Video Interaction Project in Brazil
A study testing Video Interaction Project (VIP) program in people with Parenting, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Video Interaction Project (VIP) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Caregiver is under 18 years old; and
- Child has a neurodevelopmental disability or known or suspected genetic syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting
- Being tested
- Video Interaction Project (VIP) program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Interaction Project (VIP) programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Video Interaction Project (VIP) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Baseline Visit, Visit 4 (7 months)
Secondary outcomes (3)
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."
Measured: 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.
Measured: 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.
Measured: Baseline Visit, Visit 4 (7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start5 Feb 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
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
- NCT05198739
- Sponsor's protocol ID
- 20-00057
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Pilot Implementation of the Video Interaction Project in Brazil
- ClinicalTrials.gov ID
- NCT05198739
- Acronym / sponsor ID
- 20-00057
- Conditions
- Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 20 Jan 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video Interaction Project (VIP) Group | Experimental | Other: Video Interaction Project (VIP) programParent-Child dyads will participate in a Video Interaction Project to encourage parenting practices/relationships and child development by promoting positive parenting practices. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Caregiver is under 18 years old; and
- Child has a neurodevelopmental disability or known or suspected genetic syndrome
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 |
|---|---|---|
| Video Interaction Project (VIP) programVideo 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. | Other | Video Interaction Project (VIP) Group |
Primary outcome
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.
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.
3 secondary outcomes
Change in Depression in Caregivers
Time frame: Baseline Visit, Visit 4 (7 months)
Change in Stress in Caregivers
Time frame: Baseline Visit, Visit 4 (7 months)
Child Development (CS)
Time frame: Baseline Visit, Visit 4 (7 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
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 Video Interaction Project (VIP) program in people with Parenting, 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 4 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: finished, as of the sponsor's last update on 5 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Percentage of Acceptance of the Video Interaction Project (time frame: Baseline Visit, Visit 4 (7 months)). The study lists 4 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 5 Dec 2023.