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NCT07772128
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Evaluating the Feasibility and Effects of PULS

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

16 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2027-01-01

Completion Date

2029-12-30

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

BEHAVIORAL

PULS

A cognitive behavioral treatment targeting prosocial behavior, criminal attitudes, and recidivism.

BEHAVIORAL

TAU

Treatment as usual at the institution.