Feasibility, Acceptability and Preliminary Treatment Effects of Adolescent Community Reinforcement Approach, A-CRA, for Youth in Compulsory Institutional Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Treatment completion.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: TAU (Behavioral)
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.
干预措施: TAU (Behavioral)
结局指标
主要结局
Treatment completion.
时间窗: Immediately after completion.
Percentage of treatment completers defined as participants who underwent all planned A-CRA modules.
Attrition
时间窗: During treatment and at follow up 6 months.
Attrition defined as participants discontinuing treatment and assessments.
Inclusion rate.
时间窗: 0 weeks.
Proportion of youth accepting to participate after being informed about randomization and offered treatment.
次要结局
- Alcohol Use Disorders Identification Test(0 weeks, 14 weeks and at follow up 6 months after treatment.)
- Emotion regulation(0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Acceptability of treatment(Post treatment.)
- Goal directed behavior, engagement in goal behaviors and obstacles to prosocial and healthy behavioral patterns(0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Length of treatment sessions(Registered after every session)
- Depression, anxiety and stress(0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Level of Service/Case Management Inventory(0 weeks, 14 weeks and at follow up 6 months after treatment.)
- Treatment period(0 weeks to treatment completion.)
- Ongoing alcohol/drug cravings(0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Psychological flexibility(0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Negative effects of treatment(7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Completed treatment sessions(Registered weekly)
- Pro-social behavior(0 weeks, 7 weeks, 14 weeks and at follow up 6 months after treatment.)
- Drug Use Disorders Identification Test(0 weeks, 14 weeks and at follow up 6 months after treatment.)
研究者
Tobias Lundgren
Associate Professor
Karolinska Institutet