Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03035877
Other study ID # 1R01DA041425-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2017
Est. completion date April 13, 2023

Study information

Verified date May 2024
Source Oregon Social Learning Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date April 13, 2023
Est. primary completion date March 23, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 26 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multisystemic Therapy-Emerging Adults
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.
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 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.

Locations

Country Name City State
United States North American Family Institute Hamden Connecticut
United States North American Family Institute Hartford Connecticut
United States Youth Villages Johnson City Tennessee
United States North American Family Institute New Haven Connecticut

Sponsors (7)

Lead Sponsor Collaborator
Oregon Social Learning Center Chestnut Health Systems, Connecticut Department of Children and Families, Court Support Services Division, North American Family Institute, University of Massachusetts, Worcester, Youth Villages

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 16 months pre-Baseline compared with 16 months post-Baseline.
Primary 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). Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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. Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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. Baseline to 16 months.
Secondary 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). Baseline to 16 months.
Secondary 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. Baseline to 16 months.
Secondary 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). Baseline to 16 months.
See also
  Status Clinical Trial Phase
Completed NCT02922335 - Multisystemic Therapy-Emerging Adults Trial N/A
Recruiting NCT05606978 - The Effectiveness of Blended Forensic Ambulant Systemic Therapy N/A
Completed NCT00708695 - Age-17 Follow-up of Home Visiting Intervention
Completed NCT02427672 - The Effect of Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior N/A
Completed NCT03627312 - Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders Phase 2/Phase 3
Recruiting NCT04281966 - Testing the Efficacy of the Ability School Engagement Partnership Program (ASEP) N/A
Completed NCT02674516 - The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior N/A
Completed NCT02334098 - Omega-3 Supplementation and Behavior Problems Phase 2/Phase 3
Recruiting NCT06353204 - Effectiveness of the Justice Diversion Halt-intervention N/A
Completed NCT03036683 - Transcranial Direct Current Stimulation in Offenders N/A
Recruiting NCT06032520 - The Effectiveness of Forensic Outpatient Systemic Therapy: a Multiple Case Experimental Design