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Evaluating the Feasibility and Effects of PULS

NCT07772128 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Anti Social Behavior

Interventions

BEHAVIORAL

PULS

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

BEHAVIORAL

TAU

Treatment as usual at the institution.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-12-30
Completion
2029-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772128 on ClinicalTrials.gov