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

Primary Purpose

Substance Use Disorders, Criminal Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
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 (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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as usual, TAU

TAU + A-CRA

Arm Description

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, 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.

Outcomes

Primary Outcome Measures

Attrition
Attrition defined as participants discontinuing treatment and assessments.
Inclusion rate.
Proportion of youth accepting to participate after being informed about randomization and offered treatment.
Treatment completion.
Percentage of treatment completers defined as participants who underwent all planned A-CRA modules.

Secondary Outcome Measures

Completed treatment sessions
Proportion of treatment sessions completed in TAU + A-CRA compared to TAU.
Length of treatment sessions
Average length of treatment sessions in TAU + A-CRA compared to TAU.
Treatment period
Defined as number of weeks from treatment initiation to treatment completion.
Acceptability of treatment
Acceptability is measured using a 7-point Likert-scale, ranging from 1 (not at all helpful) to 7 (very helpful).
Depression, anxiety and stress
Depression Anxiety Stress Scale-21 (DASS-21; Antony, Bieling, Cox, Enns, & Swinson, 1998), a self-assessment scale with three subscales.
Pro-social behavior
Prosocial Tendencies Measure (PTM; Carlo & Randall, 2002), a self-assessment scale measuring pro-social behavior in six domains, such as altruistic, emotional, public and private behavior.
Ongoing alcohol/drug cravings
VAS Single Item Craving Question (Reid, Flammino, Starosta, Palamar, & Franck, 2006), a self-assessment VAS-scale ranging from 0 (no craving) to 100 (maximum craving).
Emotion regulation
Difficulties in Emotion Regulation Scale-16 (DERS-16; Bjureberg et al., 2016), a self-assessment scale measuring problems with emotion regulation in five domains, ability to control impulses in when distressed, non-acceptance of negative emotions, goal orientation when distressed, limited access to emotion regulation strategies perceived as effective and emotional clarity. Consists of 16 items, answers on a Likert-scale ranging from 1 (almost never) to 5 (almost always).
Goal directed behavior, engagement in goal behaviors and obstacles to prosocial and healthy behavioral patterns
Bull's-Eye Values Survey (BEVS; Lundgren et al., 2012). Therapist guided. The scale ranges from 0-7 and is illustrated with a physical metaphor of a dartboard.
Psychological flexibility
Avoidance and Fusion Questionnaire Short Version (AFQ-Y8; Livheim et al.,2016) a self-assessment scale measuring psychological flexibility in adolescents. Consists of 8 items.
Negative effects of treatment
Negative Effects Questionnaire (NEQ; Rozental, Kottorp, Boettcher, Andersson, & Carlbring, 2016) NEQ-20 investigate participants' negative effects of psychological treatments. Total range is 0-80, with higher values representing a worse outcome.
Level of Service/Case Management Inventory
Level of Service/Case Management Inventory (LS/CMI; Andrews, Bonta, & Wormith, 2000) is a clinician administered instrument to evaluate the risks and needs in youthful offenders and is often used to guide case management. Involves antisocial and pro-criminal attitudes.
Alcohol Use Disorders Identification Test
13. Alcohol Use Disorders Identification Test (AUDIT; Saunders et al., 1993) a self-assessment scale screening for hazardous drinking and alcohol abuse disorder.
Drug Use Disorders Identification Test
14. Drug Use Disorders Identification Test (DUDIT; Berman, Bergman, Palmstierna, & Schlyter, 2005) a self-assessment scale measuring the use and disorder of drugs.

Full Information

First Posted
September 14, 2021
Last Updated
October 3, 2023
Sponsor
Karolinska Institutet
Collaborators
National Board of Institutional Care, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05081934
Brief Title
Feasibility, Acceptability and Preliminary Treatment Effects of A-CRA for Youth in Compulsory Institutional Care
Official Title
Feasibility, Acceptability and Preliminary Treatment Effects of Adolescent Community Reinforcement Approach, A-CRA, for Youth in Compulsory Institutional Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
November 12, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
National Board of Institutional Care, Sweden

4. Oversight

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

5. Study Description

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.

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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual, TAU
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TAU + A-CRA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
A-CRA
Intervention Description
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
Intervention Name(s)
TAU
Intervention 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.
Primary Outcome Measure Information:
Title
Attrition
Description
Attrition defined as participants discontinuing treatment and assessments.
Time Frame
During treatment and at follow up 6 months.
Title
Inclusion rate.
Description
Proportion of youth accepting to participate after being informed about randomization and offered treatment.
Time Frame
0 weeks.
Title
Treatment completion.
Description
Percentage of treatment completers defined as participants who underwent all planned A-CRA modules.
Time Frame
Immediately after completion.
Secondary Outcome Measure Information:
Title
Completed treatment sessions
Description
Proportion of treatment sessions completed in TAU + A-CRA compared to TAU.
Time Frame
Registered weekly
Title
Length of treatment sessions
Description
Average length of treatment sessions in TAU + A-CRA compared to TAU.
Time Frame
Registered after every session
Title
Treatment period
Description
Defined as number of weeks from treatment initiation to treatment completion.
Time Frame
0 weeks to treatment completion.
Title
Acceptability of treatment
Description
Acceptability is measured using a 7-point Likert-scale, ranging from 1 (not at all helpful) to 7 (very helpful).
Time Frame
Post treatment.
Title
Depression, anxiety and stress
Description
Depression Anxiety Stress Scale-21 (DASS-21; Antony, Bieling, Cox, Enns, & Swinson, 1998), a self-assessment scale with three subscales.
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Pro-social behavior
Description
Prosocial Tendencies Measure (PTM; Carlo & Randall, 2002), a self-assessment scale measuring pro-social behavior in six domains, such as altruistic, emotional, public and private behavior.
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Ongoing alcohol/drug cravings
Description
VAS Single Item Craving Question (Reid, Flammino, Starosta, Palamar, & Franck, 2006), a self-assessment VAS-scale ranging from 0 (no craving) to 100 (maximum craving).
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Emotion regulation
Description
Difficulties in Emotion Regulation Scale-16 (DERS-16; Bjureberg et al., 2016), a self-assessment scale measuring problems with emotion regulation in five domains, ability to control impulses in when distressed, non-acceptance of negative emotions, goal orientation when distressed, limited access to emotion regulation strategies perceived as effective and emotional clarity. Consists of 16 items, answers on a Likert-scale ranging from 1 (almost never) to 5 (almost always).
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Goal directed behavior, engagement in goal behaviors and obstacles to prosocial and healthy behavioral patterns
Description
Bull's-Eye Values Survey (BEVS; Lundgren et al., 2012). Therapist guided. The scale ranges from 0-7 and is illustrated with a physical metaphor of a dartboard.
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Psychological flexibility
Description
Avoidance and Fusion Questionnaire Short Version (AFQ-Y8; Livheim et al.,2016) a self-assessment scale measuring psychological flexibility in adolescents. Consists of 8 items.
Time Frame
0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Negative effects of treatment
Description
Negative Effects Questionnaire (NEQ; Rozental, Kottorp, Boettcher, Andersson, & Carlbring, 2016) NEQ-20 investigate participants' negative effects of psychological treatments. Total range is 0-80, with higher values representing a worse outcome.
Time Frame
7 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Level of Service/Case Management Inventory
Description
Level of Service/Case Management Inventory (LS/CMI; Andrews, Bonta, & Wormith, 2000) is a clinician administered instrument to evaluate the risks and needs in youthful offenders and is often used to guide case management. Involves antisocial and pro-criminal attitudes.
Time Frame
0 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Alcohol Use Disorders Identification Test
Description
13. Alcohol Use Disorders Identification Test (AUDIT; Saunders et al., 1993) a self-assessment scale screening for hazardous drinking and alcohol abuse disorder.
Time Frame
0 weeks, 14 weeks and at follow up 6 months after treatment.
Title
Drug Use Disorders Identification Test
Description
14. Drug Use Disorders Identification Test (DUDIT; Berman, Bergman, Palmstierna, & Schlyter, 2005) a self-assessment scale measuring the use and disorder of drugs.
Time Frame
0 weeks, 14 weeks and at follow up 6 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 (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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Lundgren, PhD
Organizational Affiliation
Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.
City
Stockholm
State/Province
Stockholm County
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Lundgren, PhD
Email
tobias.lundgren@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No

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

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