- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035877
Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse
Treatment of Justice-Involved Emerging Adults With Substance Use Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prevalence of alcohol and other drug (AOD) abuse and criminal activity is highest during emerging adulthood compared to any other developmental period, and causes extraordinary costs to society. Emerging Adults (EAs; ages 17-26) with AOD abuse have greater incarceration rates than EAs without AOD abuse, and AOD-abusing offenders have significantly more recidivism, severe offending, and incarceration than other offenders. Such serious behavior interferes with successful transition into adulthood in areas such as school completion, employment and housing. Thus, there is a strong public health need for effective treatment to reduce AOD abuse and justice involvement in EAs. Surprisingly, there are no interventions with established efficacy to reduce criminal activity among EAs, with or without AOD abuse. Among younger adolescents, the comprehensive causes of antisocial behavior are addressed by effective interventions (e.g., Multisystemic Therapy [MST]; Treatment Foster Care Oregon [TFCO]), and the present investigative team has developed and evaluated a well-defined age-tailored intervention for EAs with criminal behavior. The developed intervention is an adaptation of MST and integrates a skills coaching component from TFCO, both well-established effective juvenile justice interventions. Initial MST-EA research focused on justice-involved young adults who had mental health problems, a high-risk subpopulation of offenders, but AOD abuse quickly became a primary problem the MST-EA team treated. As a single-source intervention, MST-EA targets the EA correlates of criminal activity and AOD abuse, including gainful EA activities (positive relationships, school, work, and housing) and reduced AOD abuse-in part by targeting the proximal mechanism of poor self-regulation. In a successfully completed community-based open trial, the safety, feasibility, and preliminary efficacy of the intervention were established.
The proposed study will evaluate the effectiveness of MST-EA for reducing justice involvement and AOD abuse. EAs (n = 240) with AOD abuse and justice involvement (recent arrests or release from justice facilities) will be randomized to receive MST-EA or Enhanced Treatment as Usual (E-TAU). Assessments will be completed at months 0, 2, 4, 6, 8, 12, and 16, with confirmation of outcome data using official records. Aims will be to evaluate the effect over time of MST-EA for reducing AOD abuse and criminal activity, as well as to evaluate the effect of MST-EA on the key proximal target of treatment (self-regulation) and intermediate outcomes of treatment (gainful activities). A final aim of the study will be to investigate if the direct effect of treatment on criminal activity is mediated by its effect on self-regulation, AOD abuse, and gainful activities. In this specific age group, there is a complete absence of AOD abuse and recidivism reduction treatments with demonstrated effectiveness. The ultimate effect of the proposed research would be decreased AOD abuse and justice involvement in a high-risk population, as well as improved outcomes that have significant societal impact (e.g., reduced homelessness and unemployment).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Connecticut
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Hamden, Connecticut, United States, 06518
- North American Family Institute
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Hartford, Connecticut, United States, 06114
- North American Family Institute
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New Haven, Connecticut, United States, 06510
- North American Family Institute
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Tennessee
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Johnson City, Tennessee, United States, 37601
- Youth Villages
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 16 to 26 years
- Recent arrest or release from jail/prison/detention (within the past 18 months but excluding arrest for parole/probation violations)
- Presence of alcohol or drug (AOD) abuse disorder and recent AOD use (within the past 90 days)
- Able to reside in a stable community setting (not currently homeless, not currently in-patient; can include individuals ready for discharge to the community)
Exclusion Criteria:
- Actively psychotic, suicidal, or homicidal
- Pervasive Development Disorders (PDD) or mental retardation
- Sex offending as the primary offense type
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multisystemic Therapy-Emerging Adults
This group will receive Multisystemic Therapy-Emerging Adults.
|
MST-EA is a home- and community-based treatment for emerging adults (ages 17-21) that aims to address antisocial behavior and problems caused by substance use disorders.
The model also addresses co-occurring mental health problems when present.
Therapists work directly with the young adult and his/her social network.
This treatment also involves the use of coaches who help young people develop skills for young adulthood.
Other Names:
|
Active Comparator: Enhanced Treatment as Usual
This group will have access to an enhanced version of services typically delivered to young adults who have a substance use disorder and have been in trouble with the law.
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With Enhanced Treatment as Usual (E-TAU), emerging adults will get the treatments that they usually receive when they have a substance use disorder and have been in trouble with the law.
In addition, they will receive travel vouchers for attending services, a card with an individualized list of contacts when in crisis, and facilitation with identifying need of services and accessing those services.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number and severity of criminal charges in official records in the 16 months pre-Baseline compared with the 16 months post-Baseline.
Time Frame: 16 months pre-Baseline compared with 16 months post-Baseline.
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Changes from the 16 months pre-Baseline in offending as measured by the number and severity of criminal charges in official records compared to 16 months post-Baseline.
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16 months pre-Baseline compared with 16 months post-Baseline.
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Changes from Baseline scores compared to 16 months post-Baseline Offending Behaviors (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
|
Offending behaviors as measured using the Self-Report Offending Scale (self-reports).
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Baseline to 16 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from Baseline scores compared to 16 months post-Baseline Self-efficacy (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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Self-efficacy as measured using the Self-Efficacy Scale (self-reports).
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Goal Directedness (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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Goal directedness measured using the Wills Self Control Measure (self-reports).
|
Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Responsibility Taking (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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Responsibility taking measured using the Behavioral Indicators of Conscientiousness (self-reports).
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, phencyclidine (PCP), opiates, benzodiazepines, cocaine, and specific metabolites of alcohol (Ethyl glucuronide, Ethyl sulfate).
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Treatment Usage (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
|
The number of hospitalizations, emergency room visits and other treatments for alcohol or drug use as measured using the Time Line Follow Back (self-report) and from archival records.
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Substance Use and Problems (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
|
Frequency of substance use and substance-related problems as measured by the Global Appraisal of Individual Needs (self-reports).
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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Antisocial peer involvement measured using the Peer Delinquency Scale (self-reports).
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Interpersonal Competence (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
|
Social conflict and social functioning as measured using the Interpersonal Competence Scale (self-reports).
|
Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Housing Stability (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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Housing stability as measured using the Time Line Follow Back (self-reports) and from archival records.
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Relationship Closeness and Discord (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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Relational closeness and relational discord as measured by the Network of Relationship Inventory (self-reports).
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline School/Employment Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
|
Days in school or work (gainful activities) as measured using the Time Line Follow Back (self-reports) and from archival records.
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Baseline to 16 months.
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Changes from Baseline scores compared to 16 months post-Baseline Mental Health Symptoms (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Time Frame: Baseline to 16 months.
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The severity and number of mental health symptoms as measured using the Brief Symptom Inventory and the Posttraumatic Stress Disorder Checklist (self-reports).
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Baseline to 16 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maryann Davis, Ph.D., University of Massachusetts, Worcestor
- Principal Investigator: Ashli J Sheidow, Ph.D., Chestnut Health Systems
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA041425-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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