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

NCT ID: NCT05081934

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2023-12-31

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.

Detailed Description

The primary objective of this study is to evaluate the feasibility, acceptability and preliminary effects of the empirically supported treatment A-CRA when adjusted to, and delivered in, the institutional care of SiS. Furthermore, to increase pro-social behavior/attitudes and psychological flexibility, to improve mental health and to decrease criminal behavior and substance abuse in youth suffering from substance use disorder and/or disruptive behaviors. This study consists of a qualitative and a quantitative part 1) semi-structured interviews with adolescents and therapists involved in treatment to explore experiences 2) a pilot study to evaluate acceptability, feasibility and preliminary effects of A-CRA. Treatment type and dose (number of sessions received and length of sessions) are registered to enable future analyzes. Acceptability (perceived helpfulness and comprehensibility) is measured using a 7-point Likert-scale, ranging from 1 (not at all helpful) to 7 (very helpful).

Adolescents are randomized to either standard care alone or standard care with the addition of A-CRA. 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. Randomization takes place at the individual level with even allocation to the groups. Quantitative measurements take place before, during and after treatment as well as follow up once a month for six months. Potential adverse events will be collected after treatment completion using open questions.

Conditions

Substance Use Disorders; Criminal Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as usual, TAU

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.

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

A-CRA

Intervention Type: 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

Intervention Type: 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.

Interventions

A-CRA

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.

Intervention Type: BEHAVIORAL

TAU

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Board of Institutional Care, Sweden

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Tobias Lundgren

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Lundgren, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

2021-02258

Identifier Type: -

Identifier Source: org_study_id