A Unique, Co-Designed Family-Based Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Under age 18

Non-English speaking

Under age 18

Non-English Speaking

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Adapted MDFT + TAUExperimental treatment 2 interventions
Group B: Treatment As UusualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 3 months post-intervention
2

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.

Time frame
up to 3 months post-intervention

Secondary outcomes

1

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.

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

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.

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

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.

Time frame
1) Baseline and 2) up to 3 months post-intervention.
4

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.

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

Other outcomes

1

Beck Depression Inventory (BDI)

Beck Depression Inventory will be used to assess depressive symptoms among women and their family supports at both timepoints. The BDI is a 21 question, self-report measure containing 21 Likert scale response questions (0-3), with higher scores reflecting worse depressive symptoms and outcomes. Range of scores is 0-63.

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

Beck Anxiety Inventory (BAI)

Beck Anxiety Inventory will be used to assess anxiety symptoms among women and their family supports at both timepoints. The BAI includes 21 self-report items measured on a Likert scale (0-3), with higher scores reflecting worse anxiety symptoms and outcomes. Range of scores is 0-63.

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

Specialty Treatment Court Program Engagement

Details related to substance use treatment services received, mental health services received, and continuation of specialty court treatment programming will be monitored. Engagement in specialty treatment court program will be assessed via lower rates of specialty court drop-out and higher service utilization. Specifically, participants who utilize more services and who do not drop out of the program will be considered to being engaging more in their existing specialty treatment court programming.

Time frame
Up to 3 months post-intervention.
4

Substance Use Stigma Mechanism Scale (SU-SMS)

The Substance Use Stigma Mechanism Scale (SU-SMS) will yield scores for perceived and experienced stigma related to substance use and substance use treatment. It will be administered to participants as post of the pre and post-intervention assessment battery. The measure uses 5-point Likert Scale questions to generate psychometrically validated scores for perceived stigma experienced. Scores range from 0-90 with higher scores reflecting more perceived stigma experienced.

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

Sponsors and contacts

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Ohio State University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator