The Effectiveness of A-CRA in Compulsory Institutional Care for Youth

NCT06094972 | Recruiting

• 1 other identifier: 2022-06079-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

Youth with substance use disorder (SUD) and socially disruptive behaviour (such as criminality) who are placed in compulsory institutional care are at high risk of continuing a destructive lifestyle into adulthood. There is a pressing need for effective treatment for this group, yet studies are scarce. The empirically supported SUD treatment Adolescent Community Reinforcement Approach, A-CRA, promotes long-term abstinence, increases social stability and decreases co-morbid psychiatric problems for youth ages 12-25. A-CRA is proven to be one of the most effective SUD treatments for youth but has only been evaluated in outpatient care. Given A-CRA's promising results for youth in vulnerable living situations, it is a reasonable treatment to adjust and evaluate in compulsory care. The main objectives are to evaluate the effectiveness of A-CRA, the short- and long-term effects on social-, emotional- and problem behavior and substance use, for youth placed in compulsory institutional care.

Conditions

Substance Use Disorders; Criminal Behavior

Outcome Measures

Primary Outcomes (1)

• Social, emotional and behavioural problems

  Measured using the Strengths and Difficulties Questionnaire

  0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, and 12 months after treatment completion

Secondary Outcomes (7)

• Self reported substance use

  0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment

• Use of alcohol

  0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completio

• Use of illegal drugs

  0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completion

• Number of days until the first relapse

  0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6 and 12 months after treatment completion

• Aggressive behavior

  0 weeks, 7 weeks and 14 weeks and at follow-up 1 month after treatment completion

Study Arms (2)

TAU + A-CRA

EXPERIMENTAL

TAU: Interventions and treatments usually offered and delivered in institutional care. See below for examples. 12-14 weekly sessions of A-CRA, a behavioral treatment for youth suffering from substance use disorder and co-occurring problems. Treatment consists of 18 procedures that aim to reduce problematic behaviors and increase constructive behaviors. Examples 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 meet youth individual goals and needs.

Behavioral: Adolescent Community Reinforcement Approach, A-CRA

TAU

ACTIVE COMPARATOR

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.

Behavioral: TAU

Interventions

Adolescent Community Reinforcement Approach, A-CRA BEHAVIORAL

A-CRA consists of eighteen treatment modules/procedures that is delivered in weekly sessions over 12-14 weeks. The overarching goal is to decrease substance use behaviours and other related, problematic behaviours such as acting out when experiencing anger, and to increase prosocial and sober behaviours, relationships and activities. The procedures are: 1) Introduction to A-CRA/treatment agreement, 2) Happiness scale and treatment goals, 3) Homework, 4) Systematic encouragement, 5) Functional analysis of substance use behaviour, 6) Functional analysis of prosocial/sober behaviour, 7) Increasing prosocial activities, 8) Drink/drug refusal, 9) Relapse prevention, 10) Sobriety sampling, 11) Communication skills, 12) Problem-solving, 13) Caregiver sessions, 14) Relationship skills, 15) Couple relationship skills, 16) Job-seeking skills, 17) Anger management, 18) Medication adherence and monitoring. Youths' individual goals and problems guide treatment planning.

TAU + A-CRA

TAU BEHAVIORAL

Standard care is defined as the interventions and treatments adolescents are usually offered and undergo in institutional care in Sweden. These are Motivational Interviewing, MI, Cognitive Behavioral Therapy, CBT, Aggression Replacement Therapy, ART or Acceptance and Commitment Therapy, ACT and PULS, a program for reducing violence and criminal behavior. Also, individually tailored interventions will be included, such as counselling or other psychological interventions. TAU will be thoroughly registered during the study since the sites in the trial differs slightly in what they offer.

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
• Suffers from SUD and socially disruptive behaviour
• Ability to read and understand informed consent and interventions

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (4)

Sundbo

Fagersta, Västmanland County, Sweden

RECRUITING

Fagersta

Lindome, Västra Götaland County, Sweden

RECRUITING

Statens institutionsstyrelse, SiS, Johannisberg

Kalix, Sweden

RECRUITING

Statens institutionsstyrelse, SiS, Ljungbacken

Uddevalla, Sweden

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Criminal Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Tobias Lundgren, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Lundgren, PhD

CONTACT

070-612 45 55; tobias.lundgren@ki.se

Sven Alfonsson, PhD

CONTACT

0730415125; sven.alfonsson@ki.se

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: PhD, Associate Professor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: September 15, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)