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Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse

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ClinicalTrials.gov Identifier: NCT03035877
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Ashli Sheidow, Oregon Social Learning Center

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE August 28, 2017
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • 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. ]
    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.
  • 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- and collateral reports).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • 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. ]
    Self-efficacy as measured using the Self-Efficacy Scale (self- and collateral reports).
  • 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. ]
    Goal directedness measured using the Wills Self Control Measure (self- and collateral reports).
  • 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. ]
    Responsibility taking measured using the Behavioral Indicators of Conscientiousness (self- and collateral reports).
  • 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. ]
    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).
  • 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.
  • 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- and collateral reports).
  • 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. ]
    Antisocial peer involvement measured using the Peer Delinquency Scale (self- and collateral reports).
  • 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- and collateral reports).
  • 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. ]
    Housing stability as measured using the Time Line Follow Back (self- and collateral reports) and from archival records.
  • 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. ]
    Relational closeness and relational discord as measured by the Network of Relationship Inventory (self- and collateral reports).
  • 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- and collateral reports) and from archival records.
  • 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. ]
    The severity and number of mental health symptoms as measured using the Brief Symptom Inventory and the Posttraumatic Stress Disorder Checklist (self- and collateral reports).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse
Official Title  ICMJE Treatment of Justice-Involved Emerging Adults With Substance Use Disorders
Brief Summary This study's purpose is to examine the effectiveness of a promising intervention for emerging adults (EAs) with alcohol and other drug (AOD) abuse and justice involvement in achieving the ultimate outcome of reduced criminal activity. The study will also examine that effect on intermediate outcomes as follows: 1) reduced AOD use; 2) greater gainful activity (increased educational success, employment and housing stability; decreased antisocial peer involvement and relationship conflict); 3) and greater improvement in self-regulation (self-efficacy, goal directedness and responsibility taking). The intervention to be tested is Multisystemic Therapy-Emerging Adults (MST-EA). MST-EA is an adaptation of MST, a well-established, effective intervention for antisocial behavior in adolescents.
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 17-21) 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 collateral reports and 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Antisocial Behavior
Intervention  ICMJE
  • Behavioral: 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 Name: MST-EA
  • Behavioral: Enhanced Treatment as Usual
    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 Name: E-TAU
Study Arms  ICMJE
  • Experimental: Multisystemic Therapy-Emerging Adults
    This group will receive Multisystemic Therapy-Emerging Adults.
    Intervention: Behavioral: Multisystemic Therapy-Emerging Adults
  • 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.
    Intervention: Behavioral: Enhanced Treatment as Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 17 to 21 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashli J Sheidow, Ph.D. 541-485-2711 AshliS@oslc.org
Contact: Maryann Davis, Ph.D. 508-856-8718 Maryann.Davis@umassmed.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035877
Other Study ID Numbers  ICMJE 1R01DA041425-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ashli Sheidow, Oregon Social Learning Center
Study Sponsor  ICMJE Oregon Social Learning Center
Collaborators  ICMJE University of Massachusetts, Worcester
Investigators  ICMJE Not Provided
PRS Account Oregon Social Learning Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP