A Unique, Co-Designed Family-Based Therapy

NCT07587359 | Not Yet Recruiting DMC

• 2 other identifiers: 20251206K23DA058053
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.Will the inclusion of the adapted MDFT intervention be feasible among the target population?
2. 2.Will participant dyads assigned to the adapted intervention perceive the intervention as acceptable and beneficial?

Conditions

Opioid Abuse (Disorder)

Keywords

opioid use; sex trafficking; sex trade involvement; family intervention; specialty treatment court program

Outcome Measures

Primary Outcomes (2)

• Intervention Feasibility

  Feasibility will be assessed using rates of intervention engagement/utilization, among participating dyads. Intervention engagement will be measured by the number of sessions attended by participants assigned to the adapted MDFT intervention. Number of sessions utilized will range from 0-20, a higher number of sessions utilized will reflect better treatment engagement. Participants who receive 4 or more sessions will be considered to have engaged in the intervention.

  up to 3 months post-intervention

• Client Satisfaction Questionnaire 8

  The CSQ-8 consists of 8 questions that assess intervention recipient's satisfaction with the intervention they received. The questions are scored on 4-point Likert scales, range of scores is 1-32 with higher scores reflecting higher satisfaction with the intervention.

  up to 3 months post-intervention

Secondary Outcomes (4)

• Family Assessment Device (FAD-12)

  1) Baseline and 2) up to 3 months post-intervention

• Family Environment Scale

  1) Baseline and 2) up to 3 months post-intervention

• Perceived Social Support - Family Assessment (PSS-FA)

  1) Baseline and 2) up to 3 months post-intervention.

• Addiction Severity Index (ASI)

  1) Baseline and 2) up to 3 months post intervention.

Other Outcomes (4)

• Beck Depression Inventory (BDI)

  1) Baseline and 2) up to 3 months post-intervention.

• Beck Anxiety Inventory (BAI)

  1) Baseline and 2) up to 3 months post-intervention.

• Specialty Treatment Court Program Engagement

  Up to 3 months post-intervention.

Study Arms (2)

Adapted MDFT + TAU

EXPERIMENTAL

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.

Behavioral: Adapted Multi-Dimensional Family Therapy; Behavioral: Specialty Treatment Court Program Services

Treatment As Uusual

ACTIVE COMPARATOR

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.

Behavioral: Specialty Treatment Court Program Services

Interventions

Adapted Multi-Dimensional Family Therapy BEHAVIORAL

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 damaged relationships, build trust, and ultimately develop new strategies of supporting one another's needs with emphasis on supporting women's reductions in substance use. Interventionists work with family dyads to address problems underlying familial stress, conflict, and low support as they arise. Successful strategies to navigate these challenges in session are then translated to outside of sessions to promote self-sustaining changes within families.

Adapted MDFT + TAU

Specialty Treatment Court Program Services BEHAVIORAL

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.

Adapted MDFT + TAU; Treatment As Uusual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Willing to participate in a hypothetical family intervention

You may not qualify if:

• Under age 18
• Non-English speaking
• Under age 18
• Non-English Speaking

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Aaron W Murnan, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy Solove

CONTACT

614-247-8366; solove.3@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): April 28, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)