A Unique, Co-Designed Family-Based Therapy
Purpose
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.
Condition
- Opioid Abuse (Disorder)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Adapted MDFT + TAU |
Participant dyads in this arm will receive up to 20 sessions of the adapted Multi-Dimensional Family Therapy (MDFT) intervention in addition to services received as part of their treatment as usual (TAU) received as part of their specialty treatment court program. |
|
|
Active Comparator Treatment As Uusual |
This arm receives the normal services offered through the specialty court treatment program they are currently enrolled in. This typically includes individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Ohio State University
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.