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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

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

Study Summary

This trial will test an intervention to help new mothers who are addicted to opioids be more responsive to their babies. The intervention is delivered through videos that the mothers watch and then discuss with a coach.

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.Check my eligibility

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.See study design

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 below

Select...

I am an adult mother with a child who is 3 years old or younger.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of OregonLead Sponsor

80 Previous Clinical Trials

46,726 Total Patients Enrolled

1 Trials studying Substance Abuse

13,498 Patients Enrolled for Substance Abuse

Philip A Fisher, Ph.D.Principal InvestigatorUniversity of Oregon

Media Library

Filming Interactions to Nurture Development (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04749771 — N/A

Substance Abuse Research Study Groups: Filming Interactions to Nurture Development (FIND), The Healthy Toddler Program (HTP)

Substance Abuse Clinical Trial 2023: Filming Interactions to Nurture Development Highlights & Side Effects. Trial Name: NCT04749771 — N/A

Filming Interactions to Nurture Development (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04749771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this trial for prospective participants?

"Affirmative, clinicaltrials.gov data indicate that this medical experiment is in search of participants. It was posted on June 4th 2021 and updated most recently on June 27th 2022. 180 patients are expected to be admitted across a single site for the trial's duration."

Answered by AI

What is the participant capacity of this clinical trial?

"Affirmative, according to clinicaltrials.gov the trial is actively searching for participants. It was first published on June 4th 2021 and has been updated most recently on June 27th 2022. The research necessitates 180 individuals from a single site."

Answered by AI

What aims is this research endeavor aiming to achieve?

"This clinical trial seeks to use the SDQ-Infant questionnaire to evaluate emotional and behavioural issues in children. Secondary objectives include assessing infantile unpredictability through The Questionnaire of Unpredictability in Childhood (QUIC), Mobile Messaging for Responsive Caregiving (MMRC) rate, and a fidelity criteria rubric which assesses intervention efficacy over a span of 3-4 months post baseline and 6 months after endpoint."

Answered by AI