A Unique, Co-Designed Family-Based Therapy
21. juli 2026 oppdatert av: Ohio State University
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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sandy Solove
- Telefonnummer: 614-247-8366
- E-post: solove.3@osu.edu
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43210
- Rekruttering
- The Ohio State University
-
Ta kontakt med:
- Sandy Solove
- Telefonnummer: 614-247-8366
- E-post: solove.3@osu.edu
-
Hovedetterforsker:
- Aaron Murnan, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Adapted MDFT + TAU
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.
|
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.
|
|
Aktiv komparator: Treatment As Uusual
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention Feasibility
Tidsramme: 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.
|
up to 3 months post-intervention
|
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Client Satisfaction Questionnaire 8
Tidsramme: 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.
|
up to 3 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Family Assessment Device (FAD-12)
Tidsramme: 1) Baseline and 2) up to 3 months post-intervention
|
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.
|
1) Baseline and 2) up to 3 months post-intervention
|
|
Family Environment Scale
Tidsramme: 1) Baseline and 2) up to 3 months post-intervention
|
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.
|
1) Baseline and 2) up to 3 months post-intervention
|
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Perceived Social Support - Family Assessment (PSS-FA)
Tidsramme: 1) Baseline and 2) up to 3 months post-intervention.
|
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.
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1) Baseline and 2) up to 3 months post-intervention.
|
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Addiction Severity Index (ASI)
Tidsramme: 1) Baseline and 2) up to 3 months post intervention.
|
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.
|
1) Baseline and 2) up to 3 months post intervention.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Beck Depression Inventory (BDI)
Tidsramme: 1) Baseline and 2) up to 3 months post-intervention.
|
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.
|
1) Baseline and 2) up to 3 months post-intervention.
|
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Beck Anxiety Inventory (BAI)
Tidsramme: 1) Baseline and 2) up to 3 months post-intervention.
|
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.
|
1) Baseline and 2) up to 3 months post-intervention.
|
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Specialty Treatment Court Program Engagement
Tidsramme: Up to 3 months post-intervention.
|
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.
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Up to 3 months post-intervention.
|
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Substance Use Stigma Mechanism Scale (SU-SMS)
Tidsramme: 1) Baseline and 2) up to 3 months post-intervention.
|
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.
|
1) Baseline and 2) up to 3 months post-intervention.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Aaron W Murnan, PhD, Ohio State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. juni 2026
Primær fullføring (Antatt)
28. april 2028
Studiet fullført (Antatt)
28. april 2028
Datoer for studieregistrering
Først innsendt
1. mai 2026
Først innsendt som oppfylte QC-kriteriene
8. mai 2026
Først lagt ut (Faktiske)
14. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20251206
- K23DA058053 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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Nei
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Nei
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