NCT02922335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

July 26, 2016

Last Update Submit

May 18, 2023

Conditions

Keywords

Antisocial BehaviorMental IllnessEmerging AdulthoodCriminal BehaviorSerious Mental Illness

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 months pre-baseline compared with 16 months post-baseline

Secondary Outcomes (12)

  • Changes from Baseline scores compared to 16 months post-Baseline Self-efficacy (measured at 0,2,4,6,8,12 and 16 months).

    Baseline to16 months

  • Changes from Baseline scores compared to 16 months post-Baseline Goal directness (measured at 0,2,4,6,8,12 and 16 months).

    Baseline to16 months

  • Changes from Baseline scores compared to 16 months post-Baseline Responsibility taking (measured at 0,2,4,6,8,12 and 16 months).

    Baseline to16 months

  • Changes from Baseline scores compared to 16 months post-Baseline Symptoms (measured at 0,2,4,6,8,12 and 16 months).

    Baseline to16 months

  • Changes from Baseline scores compared to 16 months post-Baseline Treatment Usage (measured at 0,2,4,6,8,12 and 16 months).

    Baseline to16 months

  • +7 more secondary outcomes

Study Arms (2)

Multisystemic Therapy - Emerging Adults

EXPERIMENTAL

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.

Behavioral: Multisystemic Therapy for Emerging Adults

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Treatment as Usual

Interventions

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.

Also known as: Multisystemic Therapy for Transition-Age Youth (MST-TAY)
Multisystemic Therapy - Emerging Adults

Standard services that a young person would receive if they have been in trouble with the law and also have a mental illness.

Also known as: E-TAU
Enhanced Treatment as Usual

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

North American Family Institute

Hamden, Connecticut, 06518, United States

Location

North American Family Institute

Hartford, Connecticut, 06114, United States

Location

North American Family Institute

New Haven, Connecticut, 06510, United States

Location

Youth Villages

Johnson City, Tennessee, 37601, United States

Location

Related Publications (2)

  • 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.

    PMID: 28458504BACKGROUND
  • 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.

MeSH Terms

Conditions

Antisocial Personality DisorderMental DisordersCriminal Behavior

Condition Hierarchy (Ancestors)

Personality DisordersBehavior

Study Officials

  • Maryann Davis, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR
  • Ashli Sheidow, PhD

    Oregon Social Learning Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2022

Study Completion

January 31, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Locations