A Scaleable Video Coaching Intervention for Opioid-using Mothers
NCT ID: NCT04749771
Last Updated: 2023-03-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
180 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-06-04
Study Completion Date
2025-05-31
Brief Summary
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This study will adapt and evaluate a novel, innovative, and highly scalable parenting intervention that employs video coaching to target responsive parenting, Filming Interactions to Nurture Development (FIND), among women who have been referred to or are in treatment for opioid misuse/addiction.
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Detailed Description
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The overall objective of this study is to conduct a randomized trial with a sample of opioid-using women who are in or have been referred for treatment through outpatient and inpatient services and have a child aged 0-36 months. We will use a longitudinal design with an active control condition to test the central hypothesis that associations between (a) increases in responsive caregiving and (b) subsequent caregiver opioid addiction recovery, psychological well-being, and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver executive functioning, reward responsiveness, and parent self-concept. The rationale for this work is that it simultaneously addresses the unmet needs of a large, significantly underserved population and allows for a rigorous test of our conceptual model, which specifies hypothesized underlying mechanisms and differential impact.
Conditions
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Child Behavior
Parent-Child Relations
Substance Use
Substance Abuse
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Two groups. Half of the participants will be randomized into the experimental condition (FIND) while the other half will be randomized into the active control condition (HTP)
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Research assistants collecting the data during lab visits will not know the condition of the participant and will therefore not be biased during data collection.
Study Groups
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Filming Interactions to Nurture Development (FIND)
FIND is a brief video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction. The coaching focuses on showing caregivers instances in which they are engaging in developmentally-supportive interactions during coaching sessions. FIND is delivered over 10 weekly sessions lasting 30-45 minutes. The process begins with an initial session in which the coach provides an overview, records 10-15 minutes of caregiver-child interaction, then introduces the concept of serve and return. The video is edited to show brief clips in which the caregiver is engaged in the first of five specific caregiver-based components of serve and return. The next week, the FIND coach reviews the edited clips in detail with the caregiver. Sessions continue, alternating between filming and coaching sessions until all five components have been covered sequentially.
Group Type
EXPERIMENTAL
Filming Interactions to Nurture Development
Intervention Type
BEHAVIORAL
FIND is a brief video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction collected in the home.
The Healthy Toddler Program (HTP)
HTP, the active control intervention, consists of weekly sessions alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction. This intervention will consist of 10 sessions each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will be able to discuss caregiving concerns. HTP materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.
Group Type
ACTIVE_COMPARATOR
The Healthy Toddler Program
Intervention Type
BEHAVIORAL
HTP, the active control intervention, consists of weekly sessions alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction.
Interventions
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Filming Interactions to Nurture Development
FIND is a brief video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction collected in the home.
Intervention Type
BEHAVIORAL
The Healthy Toddler Program
HTP, the active control intervention, consists of weekly sessions alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction.
Intervention Type
BEHAVIORAL
Other Intervention Names
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FIND
HTP
Eligibility Criteria
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Inclusion Criteria
* Must be an adult (18-50 years of age)
* Must be the biological parent of a child between the ages of 0-48 months of age
* Must have received, or be currently receiving, treatment for a substance use disorder for any DSM-5 class of substance use disorder except caffeine or tobacco. This includes alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics/anxiolytics, and stimulants.
* Must have their child at least two days each week at study entry
* Must be the biological parent of a child between the ages of 0-48 months of age
* Must have received, or be currently receiving, treatment for a substance use disorder for any DSM-5 class of substance use disorder except caffeine or tobacco. This includes alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics/anxiolytics, and stimulants.
* Must have their child at least two days each week at study entry
Exclusion Criteria
* Metal implants, metal fragments, pacemakers, or other electronic medical implants
* Claustrophobic
* Weigh \> 550 lbs
* Women who are or think they may be pregnant
* History of neurological disorders
* Left-handed
* Claustrophobic
* Weigh \> 550 lbs
* Women who are or think they may be pregnant
* History of neurological disorders
* Left-handed
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Oregon
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Philip A Fisher, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Oregon
Locations
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University of Oregon
Eugene, Oregon, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
256792
Identifier Type: -
Identifier Source: org_study_id
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