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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Children of mothers with substance use disorder (SUD) constitute a growing and highly vulnerable population. Evidence-based parenting interventions have the potential to both support parents' recovery and mental health by helping them cope with stress of parenthood and promote the optimal development of their children by supporting responsive parenting. The Supporting Our Families through Addiction and Recovery (SOFAR) pediatric medical home for families and children impacted by SUDs, with integrated behavioral health (IBH), provides an opportune setting for addressing the needs of mothers and children impacted by SUDs. While many families are thriving in the program, there is a strong unmet need for evidence-based parent-training interventions, particularly during the preschool period. This study aims to evaluate the implementation of a brief, parent child interaction therapy (PCIT)-based intervention, entitled Threat, harm, risk, investigation, vulnerability and engagement (THRIVE), that will be offered in the SOFAR Clinic at Boston Medical Center. THRIVE is a safe, 6-session telehealth intervention that has been tested in pediatric and community-based settings. The evidence-based suggests that THRIVE is associated with significant improvements in child behaviors and parenting stress. The investigators hypothesize that offering THRIVE through the SOFAR pediatric primary care program will be feasible and acceptable, improving access to and engagement in evidence-based parenting interventions among mothers with substance use disorder who receive parenting support through our integrated behavioral health model. In addition to studying the implementation of this evidence-based intervention, this study will allow the researchers to test data collection procedures (pre and post-interventions assessments) to inform a future clinical trial.

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.

Is the parenting intervention for substance use disorder safe for participants?

The research articles provided do not contain specific safety data for the parenting intervention for substance use disorder, nor do they mention THRIVE, Lynparza, or Olaparib in relation to safety. ^{1 2 3 4 5}

Research Team

Mei L Elansary, MD, MD

Principal Investigator

Boston Medical Center, Pediatrics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse childhood experiences among females in substance use treatment and their children: A pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Pilot randomized trial of a technology-assisted parenting intervention. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Skill training versus 12-step facilitation for parents of substance-abusing teens. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for Attention-Deficit/Hyperactivity Disorder and Retention in Outpatient Substance Use Disorder Treatment: A Retrospective Cohort Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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