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Behavioural Intervention

Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) intervention for Substance Use Disorder

N/A
Waitlist Available
Led By Mei Elansary, MD MPhil
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* English speaking
* ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since THRIVE is a non-medical, therapeutic intervention focusing on improving parenting skills via telehealth sessions, there are no direct medical side effects associated with drugs or procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the THRIVE intervention
Duration of THRIVE intervention sessions
Feasibility of the THRIVE intervention based on enrollment
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Threat, harm, risk, investigation, vulnerability and engagement (THRIVE) interventionExperimental Treatment1 Intervention
The THRIVE intervention will be offered by a trained therapist to participants (mother-child dyads) in the SOFAR Clinic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THRIVE
2017
N/A
~420

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
395 Previous Clinical Trials
875,702 Total Patients Enrolled
Washington University School of MedicineOTHER
1,970 Previous Clinical Trials
2,313,816 Total Patients Enrolled
Mei Elansary, MD MPhilPrincipal InvestigatorBoston Medical Center, Pediatrics
~33 spots leftby Dec 2025