Condition category
Mental and Behavioural Disorders
Date applied
18/06/2019
Date assigned
20/06/2019
Last edited
20/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Systematic literature reviews find only weak support for the recidivism-reducing effects of current psychological interventions for young people who commit sexual offences (YSOs). Hence, we evaluate a new, sexual abuse-specific, individualized Cognitive Behavioural Therapy (CBT) intervention, STOP, for YSOs to improve treatment effectiveness.
STOP draws on the limited existing evidence and psychological treatment modalities such as Dialectical Behaviour Therapy (DBT), Multi-systemic Therapy (MST), Motivational Interviewing (MI) and the risk, need and responsivity principles (RNR) for effective work with offender populations.
STOP aims to reduce future sexual offending through a) active reduction of those research-based, malleable recidivism risk factors that each individual YSO present and b) design of an individual stop plan against relapse to follow also after treatment termination. A supplementary support plan, c) informs the offender's network on how to strengthen skills, reduce problem behaviour and monitor that the plan is followed.

Who can participate?
13 - 21-year-old males who have been convicted of a sexual offence and are resident in one of the participating youth homes.

What does the study involve?
YSOs participate in the individualized psychological STOP intervention; newly implemented and currently provided as part of standard YSO care within SiS. The study involves no additional intervention but five extra self-report and teacher report questionnaires and an additional assessment of potential treatment-related changes in risk.

What are the possible benefits and risks of participating?
Benefits from study participation (beyond STOP treatment as such) are limited but may include improved treatment quality due to additional study-related therapist supervision and the possibility to systematically contribute opinions to improve young offender treatment. No potential risks have been identified.

Where is the study run from?
Karolinska institutet, Sweden

When is the study starting and how long is it expected to run for?
August 2019 to June 2022

Who is funding the study?
Statens institutionsstyrelse (Swedish National Board of Institutional Care R&D)

Who is the main contact?
1. Miss Mia Jörgensen (public)
Mia.Jorgensen@stat-inst.se
2. Dr Dan Wetterborg (public)
dan.wetterborg@ki.se
3. Dr Niklas Långström (scientific)
niklas.langstrom@ki.se

Trial website

Contact information

Type

Public

Primary contact

Miss Mia Jörgensen

ORCID ID

Contact details

SiS ungdomshem Bärby
Funbo-Broby 53
Uppsala
75597
Sweden
+46 (0)10 453 22 00
Mia.Jorgensen@stat-inst.se

Type

Public

Additional contact

Dr Dan Wetterborg

ORCID ID

Contact details

Division of Psychology
Department of Clinical Neuroscience
Karolinska institutet
Stockholm
171 77
Sweden
+46 (0)76 915 44 29
dan.wetterborg@ki.se

Type

Scientific

Additional contact

Dr Niklas Långström

ORCID ID

Contact details

Department of Medical Epidemiology and Biostatistics
Karolinska institutet
Stockholm
171 77
Sweden
+46 (0)704254133
niklas.langstrom@ki.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

STOP1

Study information

Scientific title

An individualized, emotion dysregulation-oriented, recidivism risk-reducing CBT intervention for institutionalized young sexual offenders: Multi-center feasibility study with pre-postdesign

Acronym

STOP

Study hypothesis

The STOP intervention reduces sexual recidivism risk in YSOs by lowering intermediate dynamic risk factors.
STOP participants have reduced criminal recidivism 3 years post-treatment compared to comparison YSOs that did not receive STOP.

Ethics approval

08/05/2019, Etikprövningsmyndigheten (Swedish Ethical Review Authority, Ethics Examination Authority
Box 2110, 750 02, Uppsala, Sweden; +46(0)10-4750800; registrator@etikprovning.se), ref: 2019-02375

Study design

Interventional multi-centre study with pre-post comparison

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request participant information/informed consent sheets (in Swedish)

Condition

Sexually abusive or offending behavior committed by adolescents

Intervention

STOP is a new, sexual abuse-specific, individualized Cognitive Behavioral Therapy (CBT) intervention aimed to reduce recidivism in adolescent sexual offenders.

STOP draws on the limited existing evidence for this offender population and modern theory and practice of established psychological treatments. These include Dialectical Behaviour Therapy (DBT), Multi-systemic Therapy (MST), and Motivational Interviewing (MI).
STOP also follows the risk, need and responsivity principles (RNR, according to Andrews & Bonta) found to improve the outcome of treatment with antisocial individuals; adolescents and sexual offenders.

Central to STOP theory is that poor emotional regulation skills contribute substantially to several of the dynamic risk factors implicated in (young) sexual offender recidivism (and assessed with risk evaluation instruments like ERASOR).
STOP aims to reduce future sexual offending through a) active reduction of those research-based, malleable recidivism risk factors that each individual YSO present and b) design of an individual stop plan against relapse to follow also after treatment termination.
A supplementary support plan, c) informs the offender's network on how to strengthen skills, reduce problem behavior and monitor that the plan is followed.

STOP is a multi-modal intervention with four treatment tracks; skills, individual therapy, network and everyday environment.
The skills track takes place individually/in groups, and provides YSOs with social learning-theory-based and sexuality-specific information and a selection of skills to practice.
The individual treatment track includes chain analysis of the sexual problem behavior of each individual YSO and establishes the stop plan.
The network track is directed towards key individuals in the youth’s network; herein the support plan is created and anchored.
Within the everyday environment track, an assigned treatment assistant works systematically with motivational efforts and to strengthen and generalize skills from the stop plan.

Overall, STOP is carried out during 17-26 weeks and comprises three tracks with 6-10 *skills sessions* of 90 min each, 10-15 *individual sessions* of 90 min each, and 6-7.5 hrs of *network work*.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Pre-post changes in expert-completed Estimate of Risk of Adolescent Sexual Offense Recidivism (ERASOR) 2.0-based, pre-specified summary scores of intermediate sexuality-specific and other dynamic risk factors for criminal recidivism, respectively. Assessments are conducted by trained and supervised evaluators (other than the therapist) and cover the past month at baseline and at follow-up the past month immediately before the completion of the intervention.
2. Register-based sexual and (non-sexual) violent criminal recidivism rates (suspicions according to the National Crime Register) for 3 years following completed treatment.

Secondary outcome measures

1a. Pre-midtherapy-post changes in self-reported emotional instability problems according to the Difficulties in Emotion Regulation Scale (DERS-16).
1b. Pre-midtherapy-post changes in teacher-rated impulse control difficulties according to the Swanson, Nolan and Pelham scales (SNAP-IV).
2. Register-based psychiatric diagnoses and psychotropic medication use, 3 years following completed treatment (according to the Swedish National Board of Health and Welfare's a) National patient register, and b) National register of prescribed and dispensed medications, respectively).
3. STOP participants are compared to two comparison groups of male, individually matched (birth year, criminal and psychiatric history) young offenders also convicted to residential treatment within the National Board of Institutional Care
I) YSOs for whom, due to logistical reasons (but not treatment refusal), STOP was not provided.
II) Young offenders convicted of non-sexual, violent index offences, not eligible for specialized sexual offending-specific treatment.

Overall trial start date

15/01/2018

Overall trial end date

31/12/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 13-21 years of age
2. Male
3. Placed in one of 4 locked institutions held by the Swedish National Board of Institutional Care (Statens institutionsstyrelse, SiS)
4. Suspected or convicted of one or more index sexual offences
5. ERASOR-rated moderate to high risk for sexual recidivism
6. Remaining time in custody four months or more
7. Sufficient understanding of Swedish / English or (in some cases) communication with an interpreter

Participant type

Other

Age group

Mixed

Gender

Male

Target number of participants

30

Participant exclusion criteria

1. Intellectual impairment (Total IQ < 70)
2. Any psychiatric disorder currently characterized by marked instability. This includes, but is not limited to, ongoing manic episode, a psychotic condition or a markedly elevated suicide risk.

Recruitment start date

01/07/2019

Recruitment end date

30/06/2022

Locations

Countries of recruitment

Sweden

Trial participating centre

SiS Bärby ungdomshem (youth home)
Funbo-Broby 53
Uppsala
755 97
Sweden

Trial participating centre

SiS Hässleholm ungdomshem (youth home)
Norregatan 20
Hässleholm
281 51
Sweden

Trial participating centre

SiS Johannisberg ungdomshem (youth home)
Johannisbergsvägen 25, Box 20
Kalix
952 21
Sweden

Trial participating centre

SiS Råby ungdomshem (youth home)
Box 24036
Lund
224 21
Sweden

Trial participating centre

SiS Fagared ungdomshem (youth home)
Box 4
Lindome
437 21
Sweden

Sponsor information

Organisation

Karolinska institutet

Sponsor details

Department of Medical Epidemiology and Biostatistics
Stockholm
171 77
Sweden
0704254133
niklas.langstrom@ki.se

Sponsor type

University/education

Website

https://ki.se/en

Funders

Funder type

Government

Funder name

Statens institutionsstyrelse (Swedish National Board of Institutional Care R&D)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Two scientific reports in English submitted for publication to peer-reviewed international journals.
Implementation and feasability outcomes in 2022
Pre-post intervention results, somewhat later, in the autumn of 2022
A summary lay report in plain Swedish, early 2023

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/06/2019: Trial’s existence confirmed by Etikprövningsmyndigheten (Swedish Ethical Review Authority)