Clinical Trial: Multisystemic Therapy-Emerging Adults Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness Trial of Treatment to Reduce Serious Antisocial Behavior in Emerging Adults With Mental Illness

Brief Summary: This study's purpose is to test the effectiveness of a promising intervention for emerging adults (EAs) with mental illness (MI) and serious antisocial behavior in achieving the ultimate outcome of reduced antisocial behavior, and proximal intermediate outcomes. Multisystemic Therapy-Emerging Adults (MST-EA) is an adaptation of MST, a well-established, effective intervention for antisocial behavior in adolescents.

Detailed Summary: Serious antisocial behavior, including criminal offending, is extremely costly to society. Rates of such behavior are highest during emerging adulthood. Antisocial behavior is especially high among emerging adults (EAs) with mental illness (MI); findings suggest the majority of EAs with MI will be arrested by age 25, most with multiple arrests, and for serious charges. Thus, there is a clear public health need for effective treatments to reduce serious antisocial behavior in EAs with MI. Astonishingly, there are no established interventions with evidence of efficacy to reduce serious antisocial behavior among EAs, with or without MI. Effective antisocial behavior interventions in adolescents address the comprehensive causes of that behavior. Similarly, this team has developed and completed research on a well-defined age-tailored intervention for EAs with MI and serious antisocial behavior that addresses the correlates of EA antisocial behavior, and provides MI treatment. The intervention is an adaptation of the well-established effective juvenile antisocial behavior intervention, Multisystemic Therapy (MST). MST-EA is a single source that targets the EA correlates of antisocial behavior, including gainful activity (school, work, housing, and positive relationships) and reduced substance use, in part by targeting the proximal mechanism of poor self-regulation. MST-EA also addresses these correlates through reducing MI symptoms. The investigative team has already established the safety, feasibility, and preliminary efficacy of this type of intervention in a successfully completed community-based open trial (R34MH081374-01, PI: Davis). The proposed study will rigorously evaluate the effectiveness of MST-EA for reducing serious antisocial behavior. Specifically, 240 EAs with MI and 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 1
Sponsor: University of Massachusetts, Worcester

Current Primary Outcome: 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 Baseline in offending, measured in the number of offenses in the Self-Report Offending Scale, during the 16 months post-baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 to16 months ]
    Self-efficacy measured using the General Self-Efficacy Scale (Self Report).
  • Changes from Baseline scores compared to 16 months post-Baseline Goal directness (measured at 0,2,4,6,8,12 and 16 months). [ Time Frame: Baseline to16 months ]
    Goal directness measured using Wills Self Control Measures (Self Report and Collateral).
  • 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 to16 months ]
    Responsibility taking measured using sub-scale of the Behavioral Indicators of Conscientiousness (Self Report and Collateral).
  • Changes from Baseline scores compared to 16 months post-Baseline Symptoms (measured at 0,2,4,6,8,12 and 16 months). [ Time Frame: Baseline to16 months ]
    The number and severity of symptoms measured using the Brief Symptom Inventory (Self Report and Collateral).
  • 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 to16 months ]
    The number of hospitalizations, Emergency Room visits and treatment usage for psychiatric reasons (Self-Report and Archival records).
  • Changes from Baseline scores compared to 16 months post-Baseline Drug Screens (measured at 0,2,4,6,8,12 and 16 months). [ Time Frame: Baseline to16 months ]
    The number of positive drug screens from toxicology testing for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, opiates, benzodiazepines, and cocaine.
  • 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 to16 months ]
    Frequency of substance use and substance related problems reported on the Global Appraisal of Individual Needs (Self Report and Collateral).
  • Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers (measured at 0,2,4,6,8,12 and 16 months). [ Time Frame: Baseline to16 months ]
    Antisocial Peer Involvement measured using the Peer Delinquency Scale (Self Report and Collateral).
  • 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 to16 months ]
    Social Conflict and social functioning measured in the Interpersonal Competence Scale (Self Report and Collateral)
  • 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 to16 months ]
    Housing stability as reported by participant, collateral and archival.
  • Changes from Baseline scores compared to 16 months post-Baseline Relationships (measured at 0,2,4,6,8,12 and 16 months). [ Time Frame: Baseline to16 months ]
    Network of Relationships Inventory (Self Report and Collateral)
  • Changes from Baseline scores compared to 16 months post-Baseline School and Work(measured at 0,2,4,6,8,12 and 16 months). [ Time Frame: Baseline to16 months ]
    Days in school or work measured as reported by participant, collateral and archival.


Original Secondary Outcome: Same as current

Information By: University of Massachusetts, Worcester

Dates:
Date Received: July 26, 2016
Date Started: September 2016
Date Completion: March 2020
Last Updated: December 7, 2016
Last Verified: December 2016