Evaluating the Feasibility and Effects of PULS

NCT07772128 | Not Yet Recruiting

• 1 other identifier: 2025-04344
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Strengths and Difficulties Questionnaire

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

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

Study Arms (2)

PULS

EXPERIMENTAL

Cognitive Behavioral Treatment for Youth Involved in Criminal Groups

Behavioral: PULS

TAU

ACTIVE COMPARATOR

Treatment as Usual

Behavioral: TAU

Interventions

PULS BEHAVIORAL

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

PULS

TAU BEHAVIORAL

Treatment as usual at the institution.

TAU

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

MeSH Terms

Conditions

Antisocial Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Central Study Contacts

Sven Alfonsson, PhD

CONTACT

+46730415125; sven.alfonsson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share