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Multisystemic Therapy-Emerging Adults Trial (MST-EA)

Primary Purpose

Antisocial Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multisystemic Therapy for Emerging Adults
Enhanced Treatment as Usual
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antisocial Behavior focused on measuring Antisocial Behavior, Mental Illness, Emerging Adulthood, Criminal Behavior, Serious Mental Illness

Eligibility Criteria

16 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North American Family Institute
  • North American Family Institute
  • North American Family Institute
  • Youth Villages

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multisystemic Therapy - Emerging Adults

Enhanced Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in number and severity of criminal charges in official records in the 16 months pre-baseline compared with the 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.

Secondary Outcome Measures

Changes from Baseline scores compared to 16 months post-Baseline Self-efficacy (measured at 0,2,4,6,8,12 and 16 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).
Goal directness measured using Wills Self Control Measures (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline Responsibility taking (measured at 0,2,4,6,8,12 and 16 months).
Responsibility taking measured using sub-scale of the Behavioral Indicators of Conscientiousness (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline Symptoms (measured at 0,2,4,6,8,12 and 16 months).
The number and severity of symptoms measured using the Brief Symptom Inventory (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline Treatment Usage (measured at 0,2,4,6,8,12 and 16 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).
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).
Frequency of substance use and substance-related problems reported on the Global Appraisal of Individual Needs (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers (measured at 0,2,4,6,8,12 and 16 months).
Antisocial Peer Involvement measured using the Peer Delinquency Scale (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline Interpersonal Competence (measured at 0,2,4,6,8,12 and 16 months).
Social Conflict and social functioning measured in the Interpersonal Competence Scale (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline Housing stability (measured at 0,2,4,6,8,12 and 16 months).
Housing stability as reported by participant and archival.
Changes from Baseline scores compared to 16 months post-Baseline Relationships (measured at 0,2,4,6,8,12 and 16 months).
Network of Relationships Inventory (Self Report).
Changes from Baseline scores compared to 16 months post-Baseline School and Work(measured at 0,2,4,6,8,12 and 16 months).
Days in school or work measured as reported by participant and archival.

Full Information

First Posted
July 26, 2016
Last Updated
May 18, 2023
Sponsor
University of Massachusetts, Worcester
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, Youth Villages
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1. Study Identification

Unique Protocol Identification Number
NCT02922335
Brief Title
Multisystemic Therapy-Emerging Adults Trial
Acronym
MST-EA
Official Title
Effectiveness Trial of Treatment to Reduce Serious Antisocial Behavior in Emerging Adults With Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
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, Youth Villages

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial Behavior
Keywords
Antisocial Behavior, Mental Illness, Emerging Adulthood, Criminal Behavior, Serious Mental Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multisystemic Therapy - Emerging Adults
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Multisystemic Therapy for Emerging Adults
Other Intervention Name(s)
Multisystemic Therapy for Transition-Age Youth (MST-TAY)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual
Other Intervention Name(s)
E-TAU
Intervention Description
Standard services that a young person would receive if they have been in trouble with the law and also have a mental illness.
Primary Outcome Measure Information:
Title
Change in number and severity of criminal charges in official records in the 16 months pre-baseline compared with the 16 months post-baseline.
Description
Changes from the Baseline in offending, measured in the number of offenses in the Self-Report Offending Scale, during the 16 months post-baseline.
Time Frame
16 months pre-baseline compared with 16 months post-baseline
Secondary Outcome Measure Information:
Title
Changes from Baseline scores compared to 16 months post-Baseline Self-efficacy (measured at 0,2,4,6,8,12 and 16 months).
Description
Self-efficacy measured using the General Self-Efficacy Scale (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Goal directness (measured at 0,2,4,6,8,12 and 16 months).
Description
Goal directness measured using Wills Self Control Measures (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Responsibility taking (measured at 0,2,4,6,8,12 and 16 months).
Description
Responsibility taking measured using sub-scale of the Behavioral Indicators of Conscientiousness (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Symptoms (measured at 0,2,4,6,8,12 and 16 months).
Description
The number and severity of symptoms measured using the Brief Symptom Inventory (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Treatment Usage (measured at 0,2,4,6,8,12 and 16 months).
Description
The number of hospitalizations, Emergency Room visits and treatment usage for psychiatric reasons (Self-Report and Archival records).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Drug Screens (measured at 0,2,4,6,8,12 and 16 months).
Description
The number of positive drug screens from toxicology testing for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, opiates, benzodiazepines, and cocaine.
Time Frame
Baseline to16 months
Title
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).
Description
Frequency of substance use and substance-related problems reported on the Global Appraisal of Individual Needs (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers (measured at 0,2,4,6,8,12 and 16 months).
Description
Antisocial Peer Involvement measured using the Peer Delinquency Scale (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Interpersonal Competence (measured at 0,2,4,6,8,12 and 16 months).
Description
Social Conflict and social functioning measured in the Interpersonal Competence Scale (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Housing stability (measured at 0,2,4,6,8,12 and 16 months).
Description
Housing stability as reported by participant and archival.
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline Relationships (measured at 0,2,4,6,8,12 and 16 months).
Description
Network of Relationships Inventory (Self Report).
Time Frame
Baseline to16 months
Title
Changes from Baseline scores compared to 16 months post-Baseline School and Work(measured at 0,2,4,6,8,12 and 16 months).
Description
Days in school or work measured as reported by participant and archival.
Time Frame
Baseline to16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryann Davis, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashli Sheidow, PhD
Organizational Affiliation
Oregon Social Learning Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North American Family Institute
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
North American Family Institute
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06114
Country
United States
Facility Name
North American Family Institute
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Youth Villages
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28458504
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.
Results Reference
background
PubMed Identifier
25023764
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. Erratum In: J Behav Health Serv Res. 2015 Apr;42(2):272.
Results Reference
result

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Multisystemic Therapy-Emerging Adults Trial

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