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NCT07587359NARecruiting

A Unique, Co-Designed Family-Based Therapy

Ohio State University

Start Date

6/14/2026

Completion Date

4/28/2028

Summary

The goal of this pilot trial is to evaluate the feasibility and acceptability of an adapted MDFT intervention with women who report prior OUD and sex trade involvement participating in specialty court treatment programs. The main question\[s\] the trial aims to answer are: 1. Will the inclusion of the adapted MDFT intervention be feasible among the target population? 2. Will participant dyads assigned to the adapted intervention perceive the intervention as acceptable and beneficial? Participants will be randomly assigned to receive either: 1) the adapted MDFT + TAU; or 2) TAU. Participants will complete baseline and post-intervention assessments.

Detailed Description

Given well-documented risks associated with the sex trade and opioid use, as well as a lack of interventions prospectively designed to address challenges experienced by this population, the current study represents a critical next step towards promoting the health and well-being of women who use opioids and engage in the sex trade. The current study aims to evaluate the feasibility and acceptability of co-designed, adapted family intervention offered as an adjunct to specialty treatment court programming (offered through the criminal justice system) using a pilot RCT design. Family dyads (n=60 dyads; 120 individuals) comprised of one specialty treatment court participant and one family member selected by the treatment participant will be recruited to participate in a randomized controlled trial. Participant dyads will be randomly assigned to one of two treatment arms: 1) co-designed, adapted family intervention + specialty treatment court programming or 2) specialty treatment court programming only. The primary outcomes for this pilot trial are the feasibility and acceptability of the co-designed, adapted family intervention. Preliminary efficacy for outcomes of interest will also be explored; however the current study is not powered to detect effects given the small sample size. The current study moves the field forward by pilot testing an evidence-based family intervention that has been adapted through co-design methodologies to be highly responsive to the unique needs of specialty treatment court participants.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria for Specialty Treatment Court Participants: * 18 years of age or older * Identify as a woman * meet or have met DSM5 criteria for an Opioid Use Disorder (OUD) * report current or prior sex trade involvement * attending a specialty treatment court / treatment diversion program * Identify one family member able to participate Inclusion Criteria for Family Participants * 18 years of age or older * Willing to participate in a hypothetical family intervention Exclusion Criteria for Specialty Treatment Court Participants: * Under age 18 * Non-English speaking Exclusion Criteria for Family Participants: * Under age 18 * Non-English Speaking

Interventions

BEHAVIORAL

Adapted Multi-Dimensional Family Therapy

BEHAVIORAL

Specialty Treatment Court Program Services

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Conditions

Opioid Abuse (Disorder)

Locations

The Ohio State University

Columbus, Ohio 43210

United States