Opioid Abuse (Disorder)NCT07587359
A Unique, Co-Designed Family-Based Therapy
A study testing Adapted Multi-Dimensional Family Therapy and Specialty Treatment Court Program Services in people with Opioid Abuse (Disorder), run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Abuse (Disorder)
- What is being tested?
- Adapted Multi-Dimensional Family Therapy and Specialty Treatment Court Program Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2026to 28 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under age 18
- Non-English Speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Sandy Solove, 614-247-8366, solove.3@osu.edu
Aaron Murnan, PhD
About this study
Official title: A Unique, Co-Designed Family-Based Therapy for Women With Opioid Use Disorder and Justice-Involvement
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:
- Will the inclusion of the adapted MDFT intervention be feasible among the target population?
- 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.
Read the 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.
- Conditions
- Opioid Abuse (Disorder)
- Being tested
- Adapted Multi-Dimensional Family Therapy, Specialty Treatment Court Program Services
- Keywords
- opioid use, sex trafficking, sex trade involvement, family intervention, specialty treatment court program
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Multi-Dimensional Family TherapyBehavioural
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.
Specialty Treatment Court Program ServicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Specialty Treatment Court Program Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 3 months post-intervention
Secondary outcomes (4)
Family Assessment Device (FAD-12)
The Family Assessment Device will be administered to all participants and will yield data on various domains of family functioning across the family system. The FAD-12, is a 12 self-report item measure that yields psychometrically validated subscale scores for: Involvement; responsiveness; behavioral control; communication; problem solving; and roles, which generates a psychometrically supported composite score for family functioning. Questions are scored on a Likert Scale (1-4) with lower scores reflecting better family functioning and better outcomes. Range of scores is 12-48.
Measured: 1) Baseline and 2) up to 3 months post-intervention
Family Environment Scale
The Family Environment Scale will yield scores for family conflict, cohesion, expressiveness, and quality of family relationships. It will be administered to all participants as part of the pre and post-intervention assessment battery. This measure uses True/False questions about participant's family environment to generate psychometrically validated scores for family conflict, cohesion, and quality of family relationships. Raw total scores range from 0-90. Results are interpreted by comparing individual raw scores to established normative reference ranges, typically expressed as standard T-scores with a mean of 50 and a standard deviation of 10. Scores above or below 1 standard deviation from the mean suggest significant deviation in family dimensions. Therefore higher scores suggest worse family environments and worse outcomes.
Measured: 1) Baseline and 2) up to 3 months post-intervention
Perceived Social Support - Family Assessment (PSS-FA)
The Perceived Social Support - Family Assessment (PSS-FA) will be administered to assess family support at each time point. The PSS-FA includes 20 self-report items (Yes[1]/No[0]) that yield a psychometrically validated subscale score for Family Support (range: 0-20), with higher scores reflecting higher levels of perceived support and better outcomes.
Measured: 1) Baseline and 2) up to 3 months post-intervention.
Addiction Severity Index (ASI)
Addiction Severity Index will be used to assess substance use among participants at both timepoints. ASI is a clinical/research instrument. Participants will be asked to answer questions related to the last 30 days including: days in treatment and days using various substances. Increased number of days (0-30) of reported substance use will reflect worse substance use.
Measured: 1) Baseline and 2) up to 3 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start14 Jun 2026
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse (Disorder)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Aaron W Murnan, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587359
- Sponsor's protocol ID
- 20251206
- Other IDs
- K23DA058053
- Status last verified
- Jul 2026
- First submitted
- 1 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unique, Co-Designed Family-Based Therapy for Women With Opioid Use Disorder and Justice-Involvement
- ClinicalTrials.gov ID
- NCT07587359
- Acronym / sponsor ID
- 20251206
- Conditions
- Opioid Abuse (Disorder)
- Keywords
- opioid use, sex trafficking, sex trade involvement, family intervention, specialty treatment court program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Jun 2026 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will the inclusion of the adapted MDFT intervention be feasible among the target population?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted MDFT + TAU | Experimental | Behavioral: Adapted Multi-Dimensional Family Therapy, Behavioral: Specialty Treatment Court Program ServicesParticipant 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. |
| Treatment As Uusual | Active comparator | Behavioral: Specialty Treatment Court Program ServicesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Willing to participate in a hypothetical family intervention
- Under age 18
- Non-English speaking
Key exclusion criteria (2 listed)
- Under age 18
- Non-English Speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Multi-Dimensional Family TherapyThe 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. | Behavioural | Adapted MDFT + TAU |
| Specialty Treatment Court Program ServicesSpecialty 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. | Behavioural | Adapted MDFT + TAU, Treatment As Uusual |
Primary outcome
Intervention Feasibility
Time frame: up to 3 months post-intervention
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.
Client Satisfaction Questionnaire 8
Time frame: up to 3 months post-intervention
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes
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Cannabis and Opioid Use Disorder, Study 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron W Murnan, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Multi-Dimensional Family Therapy and Specialty Treatment Court Program Services in people with Opioid Abuse (Disorder), run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy Solove (614-247-8366, solove.3@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: up to 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.