Anti Social BehaviorPULS on SiSNCT07772128
Evaluating the Feasibility and Effects of PULS
A study testing PULS and TAU in people with Anti Social Behavior, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Anti Social Behavior
- What is being tested?
- PULS and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- placed at SiS with documented criminality as a basis for placement in institutional care
Who cannot join
- extensive cognitive impairment that prevents the youth from benefiting from treatment and/or medical or psychiatric conditions that require emergency care.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Feasibility and Effects of PULS: A Cognitive Behavioral Treatment for Youth Involved in Criminal Groups in Swedish Institutional Care
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.
Read more
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
- Being tested
- PULS, TAU
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PULSBehavioural
A cognitive behavioral treatment targeting prosocial behavior, criminal attitudes, and recidivism.
TAUBehavioural
Treatment as usual at the institution.
| Study group | Role | What they receive |
|---|---|---|
| PULS | Experimental | Cognitive Behavioral Treatment for Youth Involved in Criminal Groups Receives: Behavioral: PULS |
| TAU | Active comparator | Treatment as Usual Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 (baseline) Week 30 (post-intervention) Week 42 (3-month follow-up) Week 54 (6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti Social BehaviorStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Sven Alfonsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772128
- Sponsor's protocol ID
- 2025-04344
- Other IDs
- 2025
- Acronym
- PULS on SiS
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Effects of PULS: A Cognitive Behavioral Treatment for Youth Involved in Criminal Groups in Swedish Institutional Care
- ClinicalTrials.gov ID
- NCT07772128
- Acronym / sponsor ID
- PULS on SiS / 2025-04344
- Conditions
- Anti Social Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PULS | Experimental | Behavioral: PULSCognitive Behavioral Treatment for Youth Involved in Criminal Groups |
| TAU | Active comparator | Behavioral: TAUTreatment as Usual |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- placed at SiS with documented criminality as a basis for placement in institutional care
Key exclusion criteria (1 listed)
- extensive cognitive impairment that prevents the youth from benefiting from treatment and/or medical or psychiatric conditions that require emergency care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PULSA cognitive behavioral treatment targeting prosocial behavior, criminal attitudes, and recidivism. | Behavioural | PULS |
| TAUTreatment as usual at the institution. | Behavioural | TAU |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing PULS and TAU in people with Anti Social Behavior, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sven Alfonsson, PhD (+46730415125, sven.alfonsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.