Parenting Intervention for Substance Use Disorder

Overseen By Priyanka Srivastava, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Opioid use disorder medications

Disqualifiers: Complex medical problems, Severe cognitive limitation, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parenting support program called THRIVE, designed to help mothers recovering from substance use disorder improve their parenting skills and manage stress. The researchers aim to determine if this program can be effectively implemented in a Boston Medical Center clinic that supports families affected by substance use. THRIVE consists of six telehealth sessions and seeks to improve child behavior and reduce parenting stress. The trial seeks mothers actively engaged in substance use recovery who have children aged 3 to 6 receiving primary care at the same medical center. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for families in recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves mothers engaged in formal substance use disorder recovery supports, it seems likely that continuing these medications is allowed.

What prior data suggests that the THRIVE intervention is safe for families impacted by substance use disorder?

Research has shown that the THRIVE program, a parenting support initiative, is safe. Tested in both children's clinics and community settings, studies have found it significantly improves children's behavior and reduces parental stress. Importantly, no reports of harmful side effects have emerged from participation in this program. The main goal is to enhance communication between parents and children, benefiting the entire family. As a non-medical program delivered online, it generally avoids the risks associated with medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The THRIVE intervention is unique because it specifically targets the mother-child relationship in the context of substance use disorder. Unlike standard treatments that might focus solely on the individual, THRIVE involves both the mother and child, aiming to address the family dynamics and emotional bonds that can influence recovery. Researchers are excited about this approach because it offers a more holistic way to support recovery by fostering a supportive environment at home, which could lead to more sustainable long-term outcomes.

What evidence suggests that the THRIVE intervention is effective for improving child behaviors and parenting stress?

Research has shown that the THRIVE program, which participants in this trial will receive, can assist families dealing with substance use issues. In a study with 71 women undergoing treatment for substance use, THRIVE improved parenting and child behavior. Participants reported feeling less stressed and more confident as parents. This evidence suggests that THRIVE effectively helps mothers with substance use problems enhance their parenting skills and reduce stress, benefiting both them and their children. ^{3 6 7 8 9}

Who Is on the Research Team?

Mei L Elansary, MD, MD

Principal Investigator

Boston Medical Center, Pediatrics

Are You a Good Fit for This Trial?

This trial is for mothers with substance use disorder who have children affected by their condition. It's designed to help them cope with the stress of parenthood and improve child development through a program called SOFAR, which offers integrated behavioral health support.

Inclusion Criteria

I am a mother and I speak English.

I am a mother and I am 18 years old or older.

Mothers must be engaged in formal SUD recovery supports and fall into one of two enrollment groups: A) "high-risk" substance use disorder defined as having at least one episode of relapse within the past two years OR B) "low-risk" defined as having zero episodes of relapse within the past two years

Exclusion Criteria

Children must not have any complex medical problems (as assessed by their pediatrician) that significantly impact the child's ability to interact with the mother

Mothers must not have an index child with complex medical problems (e.g., autism spectrum disorder) that significantly impact the child's ability to interact with the parent (determined by the child's primary care pediatrician)

Mothers must not be concurrently participating in another parent training intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the THRIVE intervention, a 6-session telehealth program aimed at improving child behaviors and reducing parenting stress

6 weeks

6 telehealth sessions

Follow-up

Participants are monitored for feasibility, retention, and fidelity of the THRIVE intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE

Trial Overview

The intervention being tested is THRIVE, a brief telehealth parenting program based on parent-child interaction therapy. The study will evaluate its implementation in the SOFAR Clinic and aims to see if it can improve child behaviors and reduce parenting stress.

How Is the Trial Designed?

Group I: Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention Experimental Treatment 1 Intervention

The THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic.

THRIVE is already approved in European Union, United States, Canada, Switzerland for the following indications:

Approved in European Union as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Approved in Canada as Lynparza for:

• Ovarian cancer
• Breast cancer
• Pancreatic cancer
• Prostate cancer

Approved in Switzerland as Lynparza for:

• Ovarian cancer
• Breast cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Women with substance use disorder (SUD) had significantly higher adverse childhood experiences (ACEs) scores (mean 4.9) compared to women without SUD (mean 1.9), indicating a strong link between SUD and childhood trauma.

Children of mothers with SUD also exhibited higher ACE scores (mean 3.9) than children of non-SUD mothers (mean 1.3), suggesting that maternal ACEs are associated with increased risk of trauma in their children, highlighting the need for trauma-informed interventions for both mothers and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences among females in substance use treatment and their children: A pilot study. Smith, BT., Brumage, MR., Zullig, KJ., et al.[2022]

The Parent SMART intervention, which combines an online parenting program with coaching and networking, was found to be acceptable and feasible for engaging parents of adolescents in residential treatment for substance-related issues.

Preliminary results suggest that adolescents in short-term residential care whose parents participated in Parent SMART had fewer days of alcohol use and fewer school problems compared to those whose parents only received traditional treatment, indicating potential effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Pilot randomized trial of a technology-assisted parenting intervention. Becker, SJ., Helseth, SA., Janssen, T., et al.[2022]

In a study involving 85 distressed parents of substance-abusing adolescents, 12 weeks of coping skill training (CST) resulted in greater coping skillfulness compared to 12-step facilitation (TSF), with both interventions outperforming the delayed treatment control (DTC).

Both CST and TSF significantly reduced the number of problem days caused by the adolescent's substance use, and these benefits were maintained over a 12-month follow-up, indicating their effectiveness for supporting parents in this challenging situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skill training versus 12-step facilitation for parents of substance-abusing teens. McGillicuddy, NB., Rychtarik, RG., Papandonatos, GD.[2021]

A survey of 112 pregnant women in treatment for substance use disorders showed strong interest in naltrexone, an antagonist medication that could help stop heroin and alcohol use without causing neonatal withdrawal.

The results suggest that pregnant women are open to participating in clinical trials for naltrexone treatment, indicating a potential pathway for safer substance use disorder management during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of naltrexone by pregnant women enrolled in comprehensive drug addiction treatment: an initial survey. Jones, HE.[2022]

In a study of 203 outpatients with substance use disorder (SUD), those receiving pharmacotherapy for comorbid ADHD showed significantly better long-term retention in treatment compared to those who did not receive medication, with a notable reduction in attrition risk.

Individuals without ADHD medication had a 4.9-fold increased likelihood of dropping out within 90 days, highlighting the importance of ADHD treatment in supporting sustained engagement in SUD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Attention-Deficit/Hyperactivity Disorder and Retention in Outpatient Substance Use Disorder Treatment: A Retrospective Cohort Study. Kast, KA., Rao, V., Wilens, TE.[2021]

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