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The Effectiveness of A-CRA in Compulsory Institutional Care for Youth (A-CRA at SiS)

Primary Purpose

Substance Use Disorders, Criminal Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Adolescent Community Reinforcement Approach, A-CRA
TAU
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

16 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 16-21 Placed in institutional care Suffers from SUD and socially disruptive behaviour Ability to read and understand informed consent and interventions Exclusion Criteria: Severe cognitive or psychiatric condition preventing the ability to provide informed consent or undergo assessment or interventions Serious somatic condition requiring acute medical attention

Sites / Locations

  • Statens institutionsstyrelse, SiS, JohannisbergRecruiting
  • Statens institutionsstyrelse, SiS, LjungbackenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAU + A-CRA

TAU

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Social, emotional and behavioural problems
Measured using the Strengths and Difficulties Questionnaire

Secondary Outcome Measures

Self reported substance use
Self-reported substance use, five questions
Use of alcohol
AUDIT - Alcohol Use Disorders Identification Test (Saunders et al, 1993)
Use of illegal drugs
Drug Use Disorders Identification Test (DUDIT; Berman, Bergman, Palmstierna, & Schlyter, 2005)
Number of days until the first relapse
Self-reported substance use, five questions
Aggressive behavior
Measured using the Bröset Violent Checklist (Koskela, 2012)
Goal directed behavior and values
Bull's-Eye Values Survey (BEVS; Lundgren et al., 2012)
Psychological flexibility
Avoidance and Fusion Questionnaire Short Version (AFQ-Y8; Livheim et al.,2016)

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT06094972
Brief Title
The Effectiveness of A-CRA in Compulsory Institutional Care for Youth
Acronym
A-CRA at SiS
Official Title
The Effectiveness of A-CRA in Compulsory Institutional Care for Youth - an Independent Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Substance abuse and criminality among youth in Sweden are urgent problems. More knowledge on effective interventions is crucial to help vulnerable youth at risk of developing an array of severe problems affecting both themselves, their relatives and society (Grahn, Lundgren Chassler & Padyab, 2015). Effective help for substance abuse increases chances to abandon criminality and build up a constructive life (Henderson et al, 2016, Chermack et al, 2010). Youth with severe substance abuse and psychosocial problems, such as criminal and socially disruptive behavior, often receive treatment in compulsory institutional care. The responsible party for delivering care in this domain is The Swedish National Board of Institutional Care, (Statens institutionsstyrelse, SiS). 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 delivered in lockable institutions, situated in different locations around the country. However, the institutional setting differs from standard outpatient care where most substance use treatments have been designed for. For example, the locked ward and security routines pose challenges when fostering pro-social and constructive behavior (Gevers, Poelen, Scholte, Otten & Koordeman, 2020). Every activity must be thoroughly planned to lower risks of violence or escaping and routines, such as visitations, can lower the ability and motivation to engage in positive activities outside the institution (Brauers, Kroneman, Otten, Lindauer & Popma, 2016). The Swedish Agency for Health Technology Assessment and Assessment of Social Services, SBU, concluded in a systematic review (2016) that the scientific support for several of the treatment programs conducted at SiS are inadequate. Consequently, that more research on treatment in institutional care is needed, especially high-quality studies with a study design adjusted to the specific conditions prevailing there. An empirically supported substance use treatment developed for youth ages twelve to twenty five is the Adolescent Community Reinforcement Approach, A-CRA. A-CRA promotes long-term abstinence, increase social stability and decrease depression and other co-morbid psychiatric problems according to a large number of studies since the nineteen seventies (Azrin, Sisson, Meyers, & Godley, 1982; Dennis et al., 2004; Hunt & Azrin, 1973; Godley et al., 2014; Godley et al., 2001; Godley, Smith, Passetti, & Subramaniam, 2014). A-CRA is recommended in national guidelines for the treatment of substance use disorder in adolescents (Socialstyrelsen, 2017). Treatment consists of eighteen procedures that aim to reduce problematic behaviors and increase constructive behaviors. Example of procedures are happiness scale and treatment goals, functional analysis of substance use behavior, increasing prosocial activities, drink/drug refusal, relapse prevention, communication skills, caregiver sessions, job seeking skills and anger management (Godley, Smith, Myers & Godley, 2016). Procedures are combined and tailored to youth individual goals and needs (Godley et al., 2016). A-CRA has also proven helpful for justice-involved youth with substance use disorder under probation (Henderson et al. 2016) and for homeless youth (Slesnick et al., 2007). However, as many other psychological treatments, 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. The overall objective of this research project is to scientifically evaluate the effectiveness of A-CRA in compulsory institutional care for youth with substance use disorder and criminal behavior. In addition, to explore mechanisms of change, what mediates substance abuse and criminal behavior. Youth are randomized to either treatment as usual or treatment as usual with the addition of A-CRA. Treatment as usual 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. Randomization takes place at site 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. Qualitative data will be collected by interviewing participants at 3 month follow-up. Potential adverse events will be collected after treatment completion using open questions and registered when reported by staff in the research group or at KI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Criminal Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + A-CRA
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Adolescent Community Reinforcement Approach, A-CRA
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social, emotional and behavioural problems
Description
Measured using the Strengths and Difficulties Questionnaire
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, and 12 months after treatment completion
Secondary Outcome Measure Information:
Title
Self reported substance use
Description
Self-reported substance use, five questions
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Title
Use of alcohol
Description
AUDIT - Alcohol Use Disorders Identification Test (Saunders et al, 1993)
Time Frame
0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completio
Title
Use of illegal drugs
Description
Drug Use Disorders Identification Test (DUDIT; Berman, Bergman, Palmstierna, & Schlyter, 2005)
Time Frame
0 weeks, 14 weeks and at follow-up 1, 6 and 12 months after treatment completion
Title
Number of days until the first relapse
Description
Self-reported substance use, five questions
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6 and 12 months after treatment completion
Title
Aggressive behavior
Description
Measured using the Bröset Violent Checklist (Koskela, 2012)
Time Frame
0 weeks, 7 weeks and 14 weeks and at follow-up 1 month after treatment completion
Title
Goal directed behavior and values
Description
Bull's-Eye Values Survey (BEVS; Lundgren et al., 2012)
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment
Title
Psychological flexibility
Description
Avoidance and Fusion Questionnaire Short Version (AFQ-Y8; Livheim et al.,2016)
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow-up 1, 3, 6, 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 16-21 Placed in institutional care Suffers from SUD and socially disruptive behaviour Ability to read and understand informed consent and interventions Exclusion Criteria: Severe cognitive or psychiatric condition preventing the ability to provide informed consent or undergo assessment or interventions Serious somatic condition requiring acute medical attention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Lundgren, PhD
Phone
070-612 45 55
Email
tobias.lundgren@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Alfonsson, PhD
Phone
0730415125
Email
sven.alfonsson@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Lundgren, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Statens institutionsstyrelse, SiS, Johannisberg
City
Kalix
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Granström
Facility Name
Statens institutionsstyrelse, SiS, Ljungbacken
City
Uddevalla
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Lidström, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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