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临床试验/NCT07772128
NCT07772128尚未招募不适用

Evaluating the Feasibility and Effects of PULS: A Cognitive Behavioral Treatment for Youth Involved in Criminal Groups in Swedish Institutional Care

Karolinska Institutet0 个研究点目标入组 224 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
224
主要终点
Strengths and Difficulties Questionnaire

研究概览

简要总结

Background Youth involved in criminal groups represent a growing, high-risk population within Swedish institutional care, with elevated rates of recidivism and poor long-term outcomes. Cognitive behavioral programs show promise in reducing reoffending, but evaluation research in institutional youth care, especially randomized controlled trials, remains scarce. PULS, a cognitive behavioral treatment targeting prosocial behavior, criminal attitudes, and recidivism, is implemented across the institutional youth care institutions in Sweden (SiS) but has not been scientifically evaluated.

Aim This project evaluates the feasibility and effects of PULS among youth aged 16-21 in SiS institutional care, with a focus on youth involved in criminal groups, and examines mechanisms maintaining antisocial behavior.

Methods Four studies are conducted: a within-group feasibility study (N≈50) assessing implementation and preliminary effects; a qualitative interview study (N≈30) exploring youth and therapist perceptions; a multicenter randomized controlled trial (target N=224) comparing PULS plus treatment as usual to treatment as usual alone, evaluating effects on behavioral problems, prosocial behavior, and recidivism up to 24-month follow-up; and a diagnostic study assessing psychiatric comorbidity and its association with outcomes. Data are collected via standardized instruments, diagnostic interviews, and national registers, analyzed primarily using Linear Mixed Models and time-to-event analyses.

Significance This project provides the first scientific evaluation of PULS and is one of the few randomized trials in Swedish institutional youth care, informing future intervention development for youth involved in criminal groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • placed at SiS with documented criminality as a basis for placement in institutional care

排除标准

  • extensive cognitive impairment that prevents the youth from benefiting from treatment and/or medical or psychiatric conditions that require emergency care.

研究组 & 干预措施

PULS

Experimental

Cognitive Behavioral Treatment for Youth Involved in Criminal Groups

干预措施: PULS (Behavioral)

TAU

Active Comparator

Treatment as Usual

干预措施: TAU (Behavioral)

结局指标

主要结局

Strengths and Difficulties Questionnaire

时间窗: Week 0 (baseline) Week 30 (post-intervention) Week 42 (3-month follow-up) Week 54 (6-month follow-up)

The instrument measures, among other things, behavioral problems, emotional and social problems and prosocial behavior in a self-assessment version and a teacher version.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sven Alfonsson

PhD

Karolinska Institutet

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