Video Coaching for Opioid-Using Mothers

Overseen By Philip A Fisher, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Disqualifiers: Metal implants, Pregnancy, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new parenting program called Filming Interactions to Nurture Development (FIND). It aims to help mothers in treatment for opioid addiction enhance their parenting skills through video coaching. The trial will also compare FIND to the Healthy Toddler Program, which focuses on child development without video coaching. Mothers undergoing treatment for substance use who have their young child with them at least two days a week might be a good fit for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative parenting support methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this video coaching intervention is safe for opioid-using mothers?

Research has shown that the Filming Interactions to Nurture Development (FIND) program is safe. FIND uses video coaching to assist parents by highlighting clips of their positive interactions with their children. Studies have tested FIND with mothers dealing with opioid use, and it has been well-received without serious safety issues. As FIND is not a drug or medical treatment, it presents no physical side effects. Instead, it focuses on enhancing parenting skills, making it a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Video Coaching for Opioid-Using Mothers trial because it explores innovative methods to support child development through the Filming Interactions to Nurture Development (FIND) intervention. Unlike traditional parenting support programs that might rely on verbal advice or written materials, FIND uses video coaching to provide personalized feedback. This approach allows caregivers to see their interactions with their children in action, focusing on positive, developmentally supportive behaviors. The Healthy Toddler Program (HTP), the active control, offers standard coaching without video, giving researchers a clear comparison to assess the potential benefits of visual feedback. By directly engaging caregivers in this way, the trial aims to enhance parenting strategies and improve developmental outcomes for children in these challenging family contexts.

What evidence suggests that this trial's treatments could be effective for opioid-using mothers?

Studies have shown that the Filming Interactions to Nurture Development (FIND) program, an intervention in this trial, can enhance parenting skills among mothers in opioid treatment. FIND employs video coaching to highlight positive interactions between caregiver and child, thereby strengthening supportive parenting behaviors. Research indicates that mothers participating in FIND engaged more effectively in nurturing activities with their children. This method supports child development and strengthens the parent-child bond, crucial for families facing opioid misuse. Although more data is needed to fully confirm its effectiveness, early results are promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Philip A Fisher, Ph.D.

Principal Investigator

University of Oregon

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have custody of my child for at least half of each week.

Must be in or have been referred for treatment due to maternal opioid use

Exclusion Criteria

I am or might be pregnant.

You are left-handed.

You weigh more than 550 pounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FIND or HTP intervention over 10 weekly sessions

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in parenting skills and child development outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Filming Interactions to Nurture Development
• The Healthy Toddler Program

Trial Overview

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.

How Is the Trial Designed?

Group I: Filming Interactions to Nurture Development (FIND) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

Published Research Related to This Trial

A family-centered, technology-delivered intervention was developed to support pregnant individuals with opioid use disorder (OUD) during their transition to postpartum, focusing on recovery strategies, infant care, and child welfare preparation.

Feedback from both patients and a multidisciplinary expert panel was crucial in refining the intervention, ensuring it met the needs of the target population and enhancing its usability for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project BETTER: A Family-Centered, Technology-Delivered Intervention for Pregnant People with Opioid Use Disorder. Parlier-Ahmad, AB., Eglovitch, M., Martin, S., et al.[2023]

A study involving 42 mothers with a history of opioid use disorder (OUD) revealed that their perinatal experiences significantly influence the risk of relapse within the first year postpartum.

Identified themes such as mother-infant attachment, mental health, and support systems highlight critical areas where healthcare providers can offer targeted support to reduce relapse risk during the postpartum period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking Perinatal Experiences with Opioid Use Disorder: Relapse Risk Implications. Rankin, L., Mendoza, NS., Grisham, L.[2023]

Patients with opioid use disorder (OUD) who received care in a multidisciplinary prenatal clinic were significantly more likely to exclusively breastfeed at discharge compared to matched controls without OUD, with an adjusted relative risk of 1.28.

There were no significant differences in postpartum visit compliance or effective long-term contraception use between OUD patients and controls, indicating that multidisciplinary care does not negatively impact these important postpartum outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Multidisciplinary Opioid Use Disorder Prenatal Clinic on Breastfeeding Rates and Postpartum Care. Hensel, D., Helou, NE., Zhang, F., et al.[2022]

A qualitative study involving 31 parents with opioid use disorder and 13 pediatric clinicians revealed that most parents (68%) are open to participating in group well child care (WCC) at their OUD treatment center, indicating a potential for increased engagement in care.

The study identified key barriers to implementing group WCC, such as concerns about privacy and complexity, as well as facilitators like peer support and clinician expertise, which can help shape future implementation strategies for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Well Child Care for Mothers with Opioid Use Disorder: Framework for Implementation. Goyal, N., Gannon, M., Sood, E., et al.[2023]

Mothers in recovery from opioid use disorders often face emotional barriers such as fear, guilt, and shame, which hinder their enrollment in early intervention services for their opioid-exposed infants.

Perceived stigma and the need for personal connections with service providers are significant factors influencing mothers' decisions to engage with early intervention, suggesting that a supportive, strengths-based approach could improve participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in Early Intervention Services Among Mothers in Recovery From Opioid Use Disorders. Peacock-Chambers, E., Feinberg, E., Senn-McNally, M., et al.[2022]

Pregnant and postpartum women with opioid use disorder (OUD) who are early in their recovery are at a higher risk for continued opioid and other drug misuse, as shown by a study of 29 participants that highlighted significant differences in substance use behaviors between high-risk and low-risk groups.

High-risk participants, who were less engaged in treatment, reported higher opioid cravings and were more likely to test positive for non-opioid drugs, indicating a critical need for targeted interventions to support this vulnerable population during the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Identified Stage in Recovery and Substance-Use Behaviors among Pregnant and Postpartum Women and People with Opioid Use Disorder. Szlyk, HS., Constantino-Pettit, A., Li, X., et al.[2023]

The COACHH program emphasizes the importance of building trusting relationships with pregnant and postpartum women with opioid use disorder (OUD) to enhance patient engagement and effectively address their complex needs.

A diverse care team is essential for providing specialized, time-intensive support, but challenges such as low referral rates and difficulties in measuring outcomes highlight the need for tailored care approaches for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinating Outpatient Care for Pregnant and Postpartum Women with Opioid Use Disorder: Implications from the COACHH Program. Hodgins, FE., Lang, JM., Malseptic, GG., et al.[2020]

A pilot study involving 28 pregnant and postpartum individuals receiving medication for opioid use disorder (OUD) showed that a technology-delivered educational intervention (Project BETTER) was feasible, with 61% agreeing to participate and 70% completing the modules.

Participants reported high acceptability of the intervention, feeling more comfortable and less stigmatized learning through the technology compared to traditional provider-led education, indicating potential benefits for enhancing prenatal education in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project BETTER: Preliminary Feasibility and Acceptability of a Technology-Delivered Educational Program for Pregnant and Postpartum People with Opioid Use Disorder. Martin, S., Parlier-Ahmad, AB., Eglovitch, M., et al.[2022]

Citations

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taskforce.org

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New Data Project on Treatment for Opioid Use Disorder ...

A new Task Force for Global Health project is building a surveillance system that aims to improve health outcomes of babies and their mothers ...