A Unique, Co-Designed Family-Based Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adapted Multi-Dimensional Family Therapy, Specialty Treatment Court Program Services.
- Who it may be relevant to
- Registry conditions: Opioid Abuse (Disorder). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Unique, Co-Designed Family-Based Therapy for Women With Opioid Use Disorder and Justice-Involvement
Overview
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.
Interventions
- Behavioral Adapted Multi-Dimensional Family Therapy
The adapted MDFT will be delivered during a 12 week period (max of 20 sessions). The adapted MDFT seeks to support reductions in opioid use by targeting improvements in family factors (e.g. family conflict/stress, support, functioning, and familial substance use) that relate closely to substance use and treatment outcomes. Participant dyads come together to navigate and problem-solve family-level challenges. In session, participants will learn new ways to communicate, receive support to mend dam - Behavioral Specialty Treatment Court Program Services
Specialty Treatment Court services include individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs.
Primary outcome measures
- Intervention Feasibility [Time frame: up to 3 months post-intervention]
- Client Satisfaction Questionnaire 8 [Time frame: up to 3 months post-intervention]
Secondary outcome measures (4)
- Family Assessment Device (FAD-12) [Time frame: 1) Baseline and 2) up to 3 months post-intervention]
- Family Environment Scale [Time frame: 1) Baseline and 2) up to 3 months post-intervention]
- Perceived Social Support - Family Assessment (PSS-FA) [Time frame: 1) Baseline and 2) up to 3 months post-intervention.]
- Addiction Severity Index (ASI) [Time frame: 1) Baseline and 2) up to 3 months post intervention.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Ohio State University — Columbus
Identifiers
NCT: NCT07587359 · 20251206 · K23DA058053