Feasibility, Acceptability and Preliminary Treatment Effects of A-CRA for Youth in Compulsory Institutional Care

NCT05081934 | Completed

• 1 other identifier: 2021-02258
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Substance abuse and criminal behavior are increasing among adolescents in Sweden. The Swedish National Board of Institutional Care, SiS, provides institutional care on basis of the Swedish laws Care of Young Persons (Special Provisions) Act, LVU, Care of Substance Abusers (Special Provisions) Act, LVM, Secure Youth Care Act, LSU. Treatment is provided at locked youth residential homes. The Adolescent Community Reinforcement Approach, A-CRA, an empirically supported substance use treatment, promotes long-term abstinence, increases social stability and decreases depression and other co-morbid psychiatric problems. However, A-CRA has mostly been delivered and evaluated within outpatient care. It is unclear whether A-CRA is as effective when delivered in compulsory care where many adolescents with severe substance use disorder and criminal behavior receive treatment. This study is the first part of a larger project with the overall objective to evaluate and adjust A-CRA to the compulsory care provided at National Board of Institutional Care (Statens institutionsstyrelse, SiS) for justice-involved youth. The aim of this first part is to examine feasibility, acceptability and preliminary effects of A-CRA when provided in institutional care (SiS). Furthermore, to explore experiences of undergoing and delivering A-CRA in the institutional setting. Data collected from this study will be used for improvement of a coming full scale randomized controlled trial planned for 2022. Expected results are that A-CRA is feasible in the institutional environment, that A-CRA is perceived as helpful and acceptable by therapists and adolescents, that planned procedures are feasible and data collection and recruitment works satisfactorily.

Conditions

Substance Use Disorders; Criminal Behavior

Outcome Measures

Primary Outcomes (3)

• Attrition

  Attrition defined as participants discontinuing treatment and assessments.

  During treatment and at follow up 6 months.

• Inclusion rate.

  Proportion of youth accepting to participate after being informed about randomization and offered treatment.

  0 weeks.

• Treatment completion.

  Percentage of treatment completers defined as participants who underwent all planned A-CRA modules.

  Immediately after completion.

Secondary Outcomes (14)

• Completed treatment sessions

  Registered weekly

• Length of treatment sessions

  Registered after every session

• Treatment period

  0 weeks to treatment completion.

• Acceptability of treatment

  Post treatment.

• Depression, anxiety and stress

  0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.

Study Arms (2)

Treatment as usual, TAU

ACTIVE COMPARATOR

TAU: Interventions and treatments usually offered and delivered in institutional care. For example, Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Further specification of TAU will be made in collaboration with the institutions included in the trial.

Behavioral: TAU

TAU + A-CRA

EXPERIMENTAL

Behavioral: A-CRA, a 12-14 weekly sessions long behavioral treatment for youth (ages 12-25) suffering from substance use disorder and co-occurring problems, i.e. criminal behavior. The aim is to increase constructive behavior that reduces the need of substances and creates a context where it is rewarding to stay sober. Individual functional analyses, goals and needs guides treatment planning and interventions. TAU: interventions and treatments usually offered and delivered in institutional care. For example, Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. Further specification of TAU will be made in collaboration with the institutions included in the trial.

Behavioral: A-CRA; Behavioral: TAU

Interventions

A-CRA BEHAVIORAL

12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. The average time for a placement within SiS is for boys 5,9 months and for girls 4,5 months. To further adjust A-CRA to the closed institutional care, frequency of sessions may be increased to twice a week. This is to facilitate maintaining of focus in treatment and closely follow treatment progress. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are functional analysis of substance use behavior, functional analysis of prosocial behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, anger management and caregiver sessions. Procedures are combined and tailored to youth individual goals and needs.

TAU + A-CRA

TAU BEHAVIORAL

Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT. This will be further specified and registered in the initial phase of the study, in collaboration with SiS.

TAU + A-CRA; Treatment as usual, TAU

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16-21, placed in institutional care (SiS), with substance use disorder and criminal, violent or destructive behavior, willing and able to undergo A-CRA during their placement.
• Ability to read and understand informed consent.

You may not qualify if:

• Severe cognitive or psychiatric condition that obstructs ability to provide informed consent or to undergo assessment or interventions.
• Serious somatic condition requiring acute medical attention.

Sponsors & Collaborators

• Karolinska Institutet: lead
• National Board of Institutional Care, Sweden: collaborator

Study Sites (1)

Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.

Stockholm, Stockholm County, Sweden

Location

MeSH Terms

Conditions

Substance-Related Disorders; Criminal Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Tobias Lundgren, PhD

  Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 18, 2021
• Study Start: February 16, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)