Clinical trial NCT02922335: Multisystemic Therapy-Emerging Adults Trial
Official title: Effectiveness Trial of Treatment to Reduce Serious Antisocial Behavior in Emerging Adults With Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antisocial Behavior
Keywords: Antisocial Behavior
Mental Illness
Emerging Adulthood
Criminal Behavior
Serious Mental Illness
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Oregon Social Learning Center
name: Connecticut Department of Children and Families
name: North American Family Institute
name: Court Support Services Division
name: Youth Villages
First posted: 2016-10-04
Enrollment: 193
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 populations 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in number and severity of criminal charges in official records in the 16 months pre-baseline compared with the 16 months post-baseline.
timeFrame: 16 months pre-baseline compared with 16 months post-baseline
Secondary outcomes:
measure: Changes from Baseline scores compared to 16 months post-Baseline Self-efficacy (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Goal directness (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Responsibility taking (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Symptoms (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Treatment Usage (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Drug Screens (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: 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).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Interpersonal Competence (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Housing stability (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline Relationships (measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
measure: Changes from Baseline scores compared to 16 months post-Baseline School and Work(measured at 0,2,4,6,8,12 and 16 months).
timeFrame: Baseline to16 months
Other outcomes:
Locations:
city: Hamden
country: United States
facility: North American Family Institute
state: Connecticut
city: Hartford
country: United States
facility: North American Family Institute
state: Connecticut
city: New Haven
country: United States
facility: North American Family Institute
state: Connecticut
city: Johnson City
country: United States
facility: Youth Villages
state: Tennessee
Study officials:
affiliation: University of Massachusetts, Worcester
name: Maryann Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Social Learning Center
name: Ashli Sheidow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheidow AJ, McCart MR, Davis M. Multisystemic Therapy for Emerging Adults With Serious Mental Illness and Justice Involvement. Cogn Behav Pract. 2016 Aug;23(3):356-367. doi: 10.1016/j.cbpra.2015.09.003.
citation: Davis M, Sheidow AJ, McCart MR. Reducing recidivism and symptoms in emerging adults with serious mental health conditions and justice system involvement. J Behav Health Serv Res. 2015 Apr;42(2):172-90. doi: 10.1007/s11414-014-9425-8.