Multisystemic Therapy-Emerging Adults Trial

NCT ID: NCT02922335

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Antisocial Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Multisystemic Therapy for Emerging Adults

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Multisystemic Therapy for Transition-Age Youth (MST-TAY) E-TAU

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Oregon Social Learning Center

OTHER

Sponsor Role collaborator

Connecticut Department of Children and Families

UNKNOWN

Sponsor Role collaborator

North American Family Institute

UNKNOWN

Sponsor Role collaborator

Court Support Services Division

UNKNOWN

Sponsor Role collaborator

Youth Villages

OTHER

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Maryann Davis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maryann Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Ashli Sheidow, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Social Learning Center

Locations

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North American Family Institute

Hamden, Connecticut, United States

Site Status

North American Family Institute

Hartford, Connecticut, United States

Site Status

North American Family Institute

New Haven, Connecticut, United States

Site Status

Youth Villages

Johnson City, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28458504 (View on PubMed)

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.

Reference Type RESULT
PMID: 25023764 (View on PubMed)

Other Identifiers

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1R01MH108793-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H0009053

Identifier Type: -

Identifier Source: org_study_id

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