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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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 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.
The Ohio State University
Columbus, Ohio, United States
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
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
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
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
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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.