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Behavioral Intervention
Video Coaching for Opioid-Using Mothers
N/A
Recruiting
Led By Philip A Fisher, Ph.D.
Research Sponsored by University of Oregon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be an adult (18 years or older) mother with a child between the ages of 0-36 months
Be younger than 65 years old
Must not have
Women who are or think they may be pregnant
History of neurological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a video coaching program called FIND to help women using opioids improve their parenting skills. The program targets mothers with young children and uses video feedback to enhance caregiving, which may also support the mothers' recovery and well-being.
Who is the study for?
This trial is for adult mothers (18+) who are in or have been referred to treatment for opioid misuse and have custody of their child, aged 0-36 months, at least half the time each week. It's not suitable for those with claustrophobia, neurological disorders, a weight over 550 lbs, left-handedness, pregnancy or potential pregnancy, or any metal implants/electronic medical devices.
What is being tested?
The study is testing a video coaching program called Filming Interactions to Nurture Development (FIND), designed to improve parenting among mothers dealing with opioid addiction. The Healthy Toddler Program is also part of the intervention being evaluated.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience emotional discomfort or stress related to discussing personal issues during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult mother with a child who is 3 years old or younger.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am or might be pregnant.
Select...
I have a history of neurological disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of emotional or behavioral problems in children as assessed by the SDQ-Infant questionnaire
Assessment of parent's warmth and hostility towards their child through the use of the Iowa Family Interaction Rating Scales
Assessment of the caregivers motivation via measurement on the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) scale
+10 moreSecondary study objectives
Assessment of mental health domains across psychiatric conditions via the use of the PhenX Broad Psychopathology questionnaire
Assessment of unpredictability and fragmentation of early-life environments in infants and children through the use of the Questionnaire of Unpredictability in Childhood (QUIC)
Demographic information
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Filming Interactions to Nurture Development (FIND)Experimental Treatment1 Intervention
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 II: The Healthy Toddler Program (HTP)Active Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for substance abuse include Cognitive Behavioral Therapy (CBT), Behavioral Couples Therapy (BCT), and various forms of motivational interviewing and counseling. These treatments work by modifying biased cognitions and behaviors related to substance use, improving interpersonal relationships that support recovery, and enhancing intrinsic motivation to change.
Video coaching interventions like FIND, which target responsive parenting, can be particularly effective by providing visual and practical examples of positive behaviors, thereby improving parenting skills and reducing stressors that may contribute to substance use. Understanding these mechanisms is crucial for substance abuse patients as it helps tailor interventions to their specific needs, improving the likelihood of successful outcomes.
Understanding eHealth Cognitive Behavioral Therapy Targeting Substance Use: Realist Review.A Process Evaluation of a Substance Use Brief Intervention for Adolescents in a Psychiatric Inpatient Program.Brief video intervention to teach firefighters the neurobiological basis of high risk alcohol use: A pilot study.
Understanding eHealth Cognitive Behavioral Therapy Targeting Substance Use: Realist Review.A Process Evaluation of a Substance Use Brief Intervention for Adolescents in a Psychiatric Inpatient Program.Brief video intervention to teach firefighters the neurobiological basis of high risk alcohol use: A pilot study.
Find a Location
Who is running the clinical trial?
University of OregonLead Sponsor
85 Previous Clinical Trials
44,058 Total Patients Enrolled
Philip A Fisher, Ph.D.Principal InvestigatorUniversity of Oregon
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am or might be pregnant.I am an adult mother with a child who is 3 years old or younger.You are left-handed.You weigh more than 550 pounds.I have custody of my child for at least half of each week.I have a history of neurological disorders.You experience fear or anxiety when in enclosed spaces.You have metal implants, fragments, pacemakers, or other electronic medical implants in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Filming Interactions to Nurture Development (FIND)
- Group 2: The Healthy Toddler Program (HTP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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