Clinical trial NCT03035877: Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse
Official title: Treatment of Justice-Involved Emerging Adults With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antisocial Behavior
Keywords: Antisocial Behavior
Alcohol Abuse
Drug Abuse
Young Adults
Lead sponsor: Oregon Social Learning Center
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Connecticut Department of Children and Families
name: North American Family Institute
name: Court Support Services Division
name: Youth Villages
name: Chestnut Health Systems
First posted: 2017-01-30
Enrollment: 183
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 examine the effectiveness of a promising intervention for emerging adults (EAs) with alcohol and other drug (AOD) abuse and justice involvement in achieving the ultimate outcome of reduced criminal activity. The study will also examine that effect on intermediate outcomes as follows: 1) reduced AOD use; 2) greater gainful activity (increased educational success, employment and housing stability; decreased antisocial peer involvement and relationship conflict); 3) and greater improvement in self-regulation (self-efficacy, goal directedness and responsibility taking). The intervention to be tested is Multisystemic Therapy-Emerging Adults (MST-EA). MST-EA is an adaptation of MST, a well-established, effective intervention for antisocial behavior in adolescents.

Detailed description: Prevalence of alcohol and other drug (AOD) abuse and criminal activity is highest during emerging adulthood compared to any other developmental period, and causes extraordinary costs to society. Emerging Adults (EAs; ages 17-26) with AOD abuse have greater incarceration rates than EAs without AOD abuse, and AOD-abusing offenders have significantly more recidivism, severe offending, and incarceration than other offenders. Such serious behavior interferes with successful transition into adulthood in areas such as school completion, employment and housing. Thus, there is a strong public health need for effective treatment to reduce AOD abuse and justice involvement in EAs. Surprisingly, there are no interventions with established efficacy to reduce criminal activity among EAs, with or without AOD abuse. Among younger adolescents, the comprehensive causes of antisocial behavior are addressed by effective interventions (e.g., Multisystemic Therapy \[MST\]; Treatment Foster Care Oregon \[TFCO\]), and the present investigative team has developed and evaluated a well-defined age-tailored intervention for EAs with criminal behavior. The developed intervention is an adaptation of MST and integrates a skills coaching component from TFCO, both well-established effective juvenile justice interventions. Initial MST-EA research focused on justice-involved young adults who had mental health problems, a high-risk subpopulation of offenders, but AOD abuse quickly became a primary problem the MST-EA team treated. As a single-source intervention, MST-EA targets the EA correlates of criminal activity and AOD abuse, including gainful EA activities (positive relationships, school, work, and housing) and reduced AOD abuse-in part by targeting the proximal mechanism of poor self-regulation. In a successfully completed community-based open trial, the safety, feasibility, and preliminary efficacy of the intervention were established.

The proposed study will evaluate the effectiveness of MST-EA for reducing justice involvement and AOD abuse. EAs (n = 240) with AOD abuse and justice involvement (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 official records. Aims will be to evaluate the effect over time of MST-EA for reducing AOD abuse and criminal activity, as well as to evaluate the effect of MST-EA on the key proximal target of treatment (self-regulation) and intermediate outcomes of treatment (gainful activities). A final aim of the study will be to investigate if the direct effect of treatment on criminal activity is mediated by its effect on self-regulation, AOD abuse, and gainful activities. In this specific age group, there is a complete absence of AOD abuse and recidivism reduction treatments with demonstrated effectiveness. The ultimate effect of the proposed research would be decreased AOD abuse and justice involvement in a high-risk population, as well as improved outcomes that have significant societal impact (e.g., reduced homelessness and unemployment).

Eligibility criteria: Inclusion Criteria:

* Age 16 to 26 years
* Recent arrest or release from jail/prison/detention (within the past 18 months but excluding arrest for parole/probation violations)
* Presence of alcohol or drug (AOD) abuse disorder and recent AOD use (within the past 90 days)
* Able to reside in a stable community setting (not currently homeless, not currently in-patient; can include individuals ready for discharge to the community)

Exclusion Criteria:

* Actively psychotic, suicidal, or homicidal
* Pervasive Development Disorders (PDD) or mental retardation
* Sex offending as the primary offense type

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.
measure: Changes from Baseline scores compared to 16 months post-Baseline Offending Behaviors (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 months.
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 to 16 months.
measure: Changes from Baseline scores compared to 16 months post-Baseline Goal Directedness (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 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 to 16 months.
measure: Changes from Baseline scores compared to 16 months post-Baseline Urine Drug/Alcohol Screens (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 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 to 16 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 to 16 months.
measure: Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 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 to 16 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 to 16 months.
measure: Changes from Baseline scores compared to 16 months post-Baseline Relationship Closeness and Discord (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 months.
measure: Changes from Baseline scores compared to 16 months post-Baseline School/Employment Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 months.
measure: Changes from Baseline scores compared to 16 months post-Baseline Mental Health Symptoms (measured at 0, 2, 4, 6, 8, 12 and 16 months).
timeFrame: Baseline to 16 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: Chestnut Health Systems
name: Ashli J Sheidow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcestor
name: Maryann Davis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: