CONSENT
BehavioralThe CONSENT program is a risk-, need- and responsivity (RNR) based CBT program primarily focused on reducing risk of sexual reoffending, that consists of 18-26 one-to-one sessions in correctional settings.
NCT Number: NCT06098521
The goal of this randomized controlled trial is to investigate the effects of cognitive behavioral therapy (CBT) on sexual recidivism risk in a Swedish sample of incarcerated men convicted of sexual offenses. The main question it aims to answer is: Does the CBT program CONSENT reduce the risk of recidivism in sexual offenses among males convicted of sexual offending? The CONSENT program, specifically targeting risk factors for sexual recidivism, will be compared with a waiting list. The evaluation will focus on potential change in dynamic risk factors for sexual recidivism. The study is part of the project Preventing Sexual Abuse: CBT Programs for Convicted Men and Women in a Correctional Setting.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Karolinska Institutet, Stockholm, Stockholm County, Sweden
The aim of this study is to evaluate the short-term effects of the CONSENT program. To improve participation and responsivity and minimize any unintentional side effects, men's experiences of CONSENT are also sought.
Firstly, clients' changes will be examined in two complementary ways: through professionals' assessments and through clients' assessments using questionnaires. Secondly, changes in risk will be examined at two time points (after the program and at the 4-month follow-up), and the willingness to change in order to obtain additional complementary measures of the intended change process.
The primary research question and hypothesis, based on professionals' assessment (assessment not made by the same person conducting the program), is as follows:
The following secondary research questions complement the primary question:
Participants will also report any negative side effects and serious adverse events resulting from participating in CONSENT, as well as describe positive and negative experiences related to their participation. Please note that research questions 5 and 6 apply only to individuals convicted of sexual offenses against children and/or who indicate a sexual interest in children in the LASSIE instrument measuring paraphilic interests.
The trial will be conducted within the Swedish Prison and Probation Service at prisons specialized in individuals convicted of sexual offending.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The study population is a subgroup of the study population in another study within the same project. Eligibility criteria for that study:
Inclusion criteria
Exclusion criteria
Additional eligibility criteria for the current trial:
Inclusion criteria
Exclusion criteria
The CONSENT program is a risk-, need- and responsivity (RNR) based CBT program primarily focused on reducing risk of sexual reoffending, that consists of 18-26 one-to-one sessions in correctional settings.
Time frame: 1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).
A risk/need measurement based on the SOTIPS assessment, limited to a summation measure (0-33 points; higher scores indicate higher risk) based on the following items: Sexual Offense Responsibility, Sexual Attitudes, Sexual Risk Management, Criminal Rule-Breaking Behavior, Criminal Rule-Breaking Attitudes, Stage of Change, Cooperation with Treatment, Emotional Management, Problem Solving, Impulsivity, and Social Influence.
Time frame: 1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).
Measured with the Social Problem Solving Inventory-Revised (SPSI-R) (25-125 points, higher scores indicate more difficulties).
Time frame: 1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).
Measured with the Emotion Regulation Scale-Brief version (DERS-16)(16-80 points; higher scores indicate more difficulties).
Time frame: 1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).
Measured with The Change Questionnaire (TCQ)(0-30 points, higher scores indicate more motivation).
Time frame: 1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).
Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more urges). This outcome is only for the subgroup that is convicted of a child sexual offence or self-report a sexual interest in children.
Time frame: 1) Pre-measurement at baseline. 2) Post-measurement after waiting list / CONSENT (16±2 weeks). 3) Post-measurement after CONSENT/Follow-up (16±2 weeks).
Measured with a version of the Sexual Child Molestation Risk Assessment (SChiMRA) (visual analogue scale 0-10, higher points indicate higher risk). Each of the three items are reported separately. This outcome is only for the subgroup that is convicted of a child sexual offence or self-report a sexual interest in children.
Contact information is provided by the study sponsor or research team.
Johanna Lätth, MSc Psych
CONTACT
Louise Starfelt Sutton, Ph.D.
CONTACT
Karolinska Institutet
Other
Project CONSENT: a Randomized Controlled Trial to Evaluate Cognitive Behavioral Therapy for the Prevention of Sexual Recidivism
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