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Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse

Primary Purpose

Antisocial Behavior

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multisystemic Therapy-Emerging Adults
Enhanced Treatment as Usual
Sponsored by
Oregon Social Learning Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antisocial Behavior focused on measuring Antisocial Behavior, Alcohol Abuse, Drug Abuse, Young Adults

Eligibility Criteria

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

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

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

This group will receive Multisystemic Therapy-Emerging Adults.

This group will have access to an enhanced version of services typically delivered to young adults who have a substance use disorder and have been in trouble with the law.

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 16 months pre-Baseline in offending as measured by the number and severity of criminal charges in official records compared to 16 months post-Baseline.
Changes from Baseline scores compared to 16 months post-Baseline Offending Behaviors (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Offending behaviors as measured using the Self-Report Offending Scale (self-reports).

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 as measured using the Self-Efficacy Scale (self-reports).
Changes from Baseline scores compared to 16 months post-Baseline Goal Directedness (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Goal directedness measured using the Wills Self Control Measure (self-reports).
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 the Behavioral Indicators of Conscientiousness (self-reports).
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).
The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, phencyclidine (PCP), opiates, benzodiazepines, cocaine, and specific metabolites of alcohol (Ethyl glucuronide, Ethyl sulfate).
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 other treatments for alcohol or drug use as measured using the Time Line Follow Back (self-report) and from archival records.
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 as measured by the Global Appraisal of Individual Needs (self-reports).
Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Antisocial peer involvement measured using the Peer Delinquency Scale (self-reports).
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 as measured using the Interpersonal Competence Scale (self-reports).
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 measured using the Time Line Follow Back (self-reports) and from archival records.
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).
Relational closeness and relational discord as measured by the Network of Relationship Inventory (self-reports).
Changes from Baseline scores compared to 16 months post-Baseline School/Employment Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Days in school or work (gainful activities) as measured using the Time Line Follow Back (self-reports) and from archival records.
Changes from Baseline scores compared to 16 months post-Baseline Mental Health Symptoms (measured at 0, 2, 4, 6, 8, 12 and 16 months).
The severity and number of mental health symptoms as measured using the Brief Symptom Inventory and the Posttraumatic Stress Disorder Checklist (self-reports).

Full Information

First Posted
January 26, 2017
Last Updated
June 14, 2023
Sponsor
Oregon Social Learning Center
Collaborators
University of Massachusetts, Worcester, 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
NCT03035877
Brief Title
Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse
Official Title
Treatment of Justice-Involved Emerging Adults With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Social Learning Center
Collaborators
University of Massachusetts, Worcester, 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial Behavior
Keywords
Antisocial Behavior, Alcohol Abuse, Drug Abuse, Young Adults

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Multisystemic Therapy-Emerging Adults
Arm Type
Experimental
Arm Description
This group will receive Multisystemic Therapy-Emerging Adults.
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
This group will have access to an enhanced version of services typically delivered to young adults who have a substance use disorder and have been in trouble with the law.
Intervention Type
Behavioral
Intervention Name(s)
Multisystemic Therapy-Emerging Adults
Other Intervention Name(s)
MST-EA
Intervention Description
MST-EA is a home- and community-based treatment for emerging adults (ages 17-21) that aims to address antisocial behavior and problems caused by substance use disorders. The model also addresses co-occurring mental health problems when present. Therapists work directly with the young adult and his/her social network. 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
With Enhanced Treatment as Usual (E-TAU), emerging adults will get the treatments that they usually receive when they have a substance use disorder and have been in trouble with the law. In addition, 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.
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 16 months pre-Baseline in offending as measured by the number and severity of criminal charges in official records compared to 16 months post-Baseline.
Time Frame
16 months pre-Baseline compared with 16 months post-Baseline.
Title
Changes from Baseline scores compared to 16 months post-Baseline Offending Behaviors (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Description
Offending behaviors as measured using the Self-Report Offending Scale (self-reports).
Time Frame
Baseline to 16 months.
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 as measured using the Self-Efficacy Scale (self-reports).
Time Frame
Baseline to 16 months.
Title
Changes from Baseline scores compared to 16 months post-Baseline Goal Directedness (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Description
Goal directedness measured using the Wills Self Control Measure (self-reports).
Time Frame
Baseline to 16 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 the Behavioral Indicators of Conscientiousness (self-reports).
Time Frame
Baseline to 16 months.
Title
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).
Description
The number of positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, methamphetamines, phencyclidine (PCP), opiates, benzodiazepines, cocaine, and specific metabolites of alcohol (Ethyl glucuronide, Ethyl sulfate).
Time Frame
Baseline to 16 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 other treatments for alcohol or drug use as measured using the Time Line Follow Back (self-report) and from archival records.
Time Frame
Baseline to 16 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 as measured by the Global Appraisal of Individual Needs (self-reports).
Time Frame
Baseline to 16 months.
Title
Changes from Baseline scores compared to 16 months post-Baseline Antisocial Peers Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Description
Antisocial peer involvement measured using the Peer Delinquency Scale (self-reports).
Time Frame
Baseline to 16 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 as measured using the Interpersonal Competence Scale (self-reports).
Time Frame
Baseline to 16 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 measured using the Time Line Follow Back (self-reports) and from archival records.
Time Frame
Baseline to 16 months.
Title
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).
Description
Relational closeness and relational discord as measured by the Network of Relationship Inventory (self-reports).
Time Frame
Baseline to 16 months.
Title
Changes from Baseline scores compared to 16 months post-Baseline School/Employment Involvement (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Description
Days in school or work (gainful activities) as measured using the Time Line Follow Back (self-reports) and from archival records.
Time Frame
Baseline to 16 months.
Title
Changes from Baseline scores compared to 16 months post-Baseline Mental Health Symptoms (measured at 0, 2, 4, 6, 8, 12 and 16 months).
Description
The severity and number of mental health symptoms as measured using the Brief Symptom Inventory and the Posttraumatic Stress Disorder Checklist (self-reports).
Time Frame
Baseline to 16 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashli J Sheidow, Ph.D.
Organizational Affiliation
Oregon Social Learning Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maryann Davis, Ph.D.
Organizational Affiliation
University of Massachusetts, Worcestor
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
No

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Multisystemic Therapy-Emerging Adults (MST-EA) for Substance Abuse

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