ClinicalTrials.gg
Not yet recruitingNCT07772128PULS on SiSUpdated Aug 19, 2026

Evaluating the Feasibility and Effects of PULS

An interventional study of PULS and TAU in Anti Social Behavior, sponsored by Karolinska Institutet. Not yet recruiting. Open to participants aged 16 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
16 Years to 21 Years
Sex
All
01

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.

02

Conditions studied

  • Anti Social Behavior
03

In context

Antisocial Personality Disorder

67 studies on the registry are indexed under Antisocial Personality Disorder; 10 are open to participants now.

This study's planned enrollment of 224 is above the median of 140 across 43 interventional studies indexed under Antisocial Personality Disorder.

Browse Antisocial Personality Disorder studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • extensive cognitive impairment that prevents the youth from benefiting from treatment and/or medical or psychiatric conditions that require emergency care.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (estimated)

Study arms

  • Experimental
    PULS

    Cognitive Behavioral Treatment for Youth Involved in Criminal Groups

    Behavioral: PULS

  • Active comparator
    TAU

    Treatment as Usual

    Behavioral: TAU

Interventions

  • BehavioralPULS

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

  • BehavioralTAU

    Treatment as usual at the institution.

06

What researchers measure

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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.

Of 25 interventional studies with no phase under Antisocial Personality Disorder, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 35 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Aug 19, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Dec 30, 2029
CompletionEst.
Dec 30, 2029
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07772128
Collaborators
The Swedish Research Council
Responsible party
Sven Alfonsson (PhD, Karolinska Institutet) — Principal investigator
First posted
Aug 19, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 30, 2029 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Aug 19, 2026

Study contacts

Sven Alfonsson, PhD
Contact
sven.alfonsson@ki.se
+46730415125

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion