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Multisystemic Therapy-Emerging Adults Trial (MST-EA)

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ClinicalTrials.gov Identifier: NCT02922335
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Oregon Social Learning Center
Connecticut Department of Children and Families
North American Family Institute
Court Support Services Division
Information provided by (Responsible Party):
Maryann Davis, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE October 4, 2016
Last Update Posted Date October 7, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • 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 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 Trial
Official Title  ICMJE 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 Description 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 16, with confirmation of outcome data using collateral reports and system records. The first aim will be to evaluate the effect over time of MST-EA for improving the ultimate outcome of treatment: reduced serious antisocial behavior. The second aim is to evaluate the effect of MST-EA on (a) the key proximal target of treatment (self-regulation) and (b) the proposed intermediate outcomes of treatment (gainful activity, substance use, and MI problems). The final aim will be to determine whether MST-EA's effect on the ultimate outcome is the result of its effect on the proximal target and intermediate outcomes of treatment. There is a current absence of any antisocial behavior treatments with demonstrated efficacy in this age group. The ultimate effect of the proposed research would be decreased antisocial behavior and other public health-related behaviors (MI symptoms, substance use, homelessness, unemployment) among one of the highest-risk population of individuals with MI. With an emphasis on treatment mechanisms and the near absence of MI research focused on EAs, this innovative research has high potential to advance the field.
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 for Emerging Adults
    MST-EA is a home-based therapy in which therapists work closely with each young adult. Therapists often also work with the young person's family, as appropriate. MST-EA is designed to help young people work on their own behavior. This treatment also involves the use of coaches who help young people develop skills for young adulthood.
    Other Name: Multisystemic Therapy for Transition-Age Youth (MST-TAY)
  • Behavioral: Enhanced Treatment as Usual
    Standard services that a young person would receive if they have been in trouble with the law and also have a mental illness.
    Other Name: E-TAU
Study Arms  ICMJE
  • Experimental: Multisystemic Therapy - Emerging Adults
    Multisystemic Therapy for Emerging Adults (MST-EA) is designed to help emerging adults (ages 18-21) with mental illness who have been in trouble with the law. MST-EA is a treatment program specifically for emerging adults, to increase skills and capacities that can help them reduce their antisocial behavior and help reduce problems caused by mental health illness, and alcohol or drug use when present.
    Intervention: Behavioral: Multisystemic Therapy for Emerging Adults
  • Active Comparator: 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 mental illness and have been in trouble with the law. 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.
    Intervention: Behavioral: Enhanced Treatment as Usual
Publications *

*   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: September 29, 2016)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 16-26
  • recent arrest or release from jail/prison/detention (within the past 18 months but excluding arrests for probation/parole violations)
  • presence of mood, anxiety, and/or psychotic disorders
  • able to reside in a stable community setting (not currently homeless, not currently inpatient; can include individual ready for discharge to the community)
  • subject consent

Exclusion Criteria:

  • actively psychotic, suicidal, or homicidal
  • Pervasive Developmental Disorders (PDD) or mental retardation
  • sex offending as the primary antisocial behavior
  • adults unable to consent will also be excluded from this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 26 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maryann Davis, PhD 508-856-8718 maryann.davis@umassmed.edu
Contact: Ashli Sheidow, PhD 541-485-2711 AshliS@oslc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02922335
Other Study ID Numbers  ICMJE H0009053
1R01MH108793-01 ( 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: Yes
Responsible Party Maryann Davis, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Oregon Social Learning Center
  • Connecticut Department of Children and Families
  • North American Family Institute
  • Court Support Services Division
Investigators  ICMJE
Principal Investigator: Maryann Davis, PhD University of Massachusetts, Worcester
Principal Investigator: Ashli Sheidow, PhD Oregon Social Learning Center
PRS Account University of Massachusetts, Worcester
Verification Date October 2019

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