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NCT Number: NCT07772128

Evaluating the Feasibility and Effects of PULS

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.

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Key information

Age range

16 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PULS

Behavioral

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

TAU

Behavioral

Treatment as usual at the institution.

Primary outcomes

  1. Strengths and Difficulties Questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sven Alfonsson, PhD

CONTACT

[email protected]

+46730415125

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

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

Acronym: PULS on SiS

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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