Clinical trial NCT05081934: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Criminal Behavior
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: National Board of Institutional Care, Sweden
First posted: 2021-10-18
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Attrition
timeFrame: During treatment and at follow up 6 months.
measure: Inclusion rate.
timeFrame: 0 weeks.
measure: Treatment completion.
timeFrame: Immediately after completion.
Secondary outcomes:
measure: Completed treatment sessions
timeFrame: Registered weekly
measure: Length of treatment sessions
timeFrame: Registered after every session
measure: Treatment period
timeFrame: 0 weeks to treatment completion.
measure: Acceptability of treatment
timeFrame: Post treatment.
measure: Depression, anxiety and stress
timeFrame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Pro-social behavior
timeFrame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Ongoing alcohol/drug cravings
timeFrame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Emotion regulation
timeFrame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Goal directed behavior, engagement in goal behaviors and obstacles to prosocial and healthy behavioral patterns
timeFrame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Psychological flexibility
timeFrame: 0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Negative effects of treatment
timeFrame: 7 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Level of Service/Case Management Inventory
timeFrame: 0 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Alcohol Use Disorders Identification Test
timeFrame: 0 weeks, 14 weeks and at follow up 6 months after treatment.
measure: Drug Use Disorders Identification Test
timeFrame: 0 weeks, 14 weeks and at follow up 6 months after treatment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.
state: Stockholm County
Study officials:
affiliation: Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
name: Tobias Lundgren, PhD
role: PRINCIPAL_INVESTIGATOR
References: