Clinical trial NCT05830643: Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts
Official title: Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts: A Randomized Control Trial on Individuals With Problematic Sexual Interests in Children
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Paraphilias and Paraphilic Disorders
Keywords: Paraphilias
Pedophilia
Phallometry
Group psychotherapy
Social skills
Sexual arousal
Consent
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (social skills focused psychotherapy) and control group (adult interest focused psychotherapy)
Primary purpose: TREATMENT

Brief summary: A challenge to Canadian society is the establishment of effective evidence-based interventions to prevent non-consensual sex acts. The Sexual Behaviours Clinic (SBC), located in Ottawa, Ontario, Canada, is an innovative and effective program devoted to the management of adults with persistent problematic sexual interests and behaviours (paraphilias). The primary aim of this project is to test the hypothesis that the SBC's success is due in part to its focus on consent and the enhancement of lawful and fulfilling social relationships (social skills). The study participants will include 60 voluntary male participants who have undergone an intake assessment with the SBC and show signs of paraphilic interests in children (based on the standard SBC intake questionnaire) who will be randomized into a social skills group or a control group focused on adult interests. Participants will attend these groups weekly for 3-months (12-weeks). Outcome measures will include pre-and-post social skills, sexual consent, sexual fantasy, and sexual urges surveys, pre-and-post phallometric testing (to test for objective sexual arousal), qualitative interviews of the study participants, their friends, and family members, and records of recidivism (self-report). Groups will be inclusive of individuals from varying ethnicities, backgrounds, sexual orientations, and intellectual and developmental levels.

Detailed description: 60 voluntary participants who have undergone an intake assessment with the SBC and show signs of paraphilic interests in children will be randomized into a control group or a social skills group. These groups have been running for \~15 years and the methods have been published (e.g., Fedoroff, 2020). A trained social worker and psychiatrist will facilitate the groups. Those in the control group will participate in a weekly group on adult interests for 3 months (12-weeks) and will receive the necessary psychological and/or pharmacological treatments needed for their condition. The intervention group will participate in a weekly group on consensual social skills for 3 months (12-weeks) and will receive the necessary psychological and/or pharmacological treatments needed for their condition. The groups will be compared in terms of any psychological or pharmacological treatments offered and received. It should be noted that the SBC has never offered treatment for homosexuality and does not propose to do so in this study.

Socio-demographic information of participants will be collected from a self-report measure completed at the participant's initial assessment, which is reviewed by the clinical coordinator. This questionnaire has been used in other studies completed within the SBC in the past. Participants will undergo phallometric testing to test for objective sexual arousal pre-and-post intervention. The clinical coordinator conducting the phallometric testing will be blinded to what group the participants are in. All participants will also complete baseline-standardized questionnaires including the Social Skills Inventory (SSI; Riggio, 1992), the revised Sexual Consent Scale (Humphreys \& Brousseau, 2010), the Sexual Symptom Assessment Scale (SASS; Raymond et al., 2007), and the Fantasy Checklist (Bradford \& Curry, 1991). They will complete the same questionnaires after attending the groups weekly for 3 months. In addition, after 3 months of Social Skills Therapy, a random group of 10 participants from the Social Skills group who have an identified significant other will be invited to participate in a semi-structured interview by a trained research assistant according to established qualitative methodology to investigate the efficacy of social skills therapy. Interviews will last 60-90 minutes, and a limited set of qualitative probes will revolve around the three broad themes explored during the quantitative portion of the study, namely, social skills, consent, and sexual interest. Boyatzis' (1998) principles of thematic analysis for data management and analysis will be used to analyze the overarching themes of the program. Whenever possible, analysis will be performed after each interview to inform the subsequent one, and to search for data saturation-defined as the time when no new information emerged from the interviews. Social skills and consent rubrics will structure the data analysis and coding process. An inductive process will be followed to add a quantitative understanding of the phenomenon under study.

Eligibility criteria: Inclusion Criteria:

* Male (sex at birth)
* 18 years of age or older
* Understand English
* Been assessed for a question of sexual interest in children

Exclusion Criteria:

* Cannot understand and/or read English
* Under the age of 18
* Does not have a penis
* Current or past history of psychoses
* In custody at the time of SBC assessment
* Participant shows no sexual interest in children
* Participant has already undergone group psychotherapy at the Sexual Behaviours Clinic

Primary outcomes:
measure: Penile Plethysmography/Phallometric Testing (PPG)
timeFrame: Approximately 2.5 hours to complete, depending on the length of time needed to return to baseline levels of arousal
Secondary outcomes:
measure: Social Skills Inventory (SSI)
timeFrame: Approximately 10 minutes
measure: Revised Sexual Consent Scale (SCS-R)
timeFrame: Approximately 10-20 minutes
measure: Sexual Symptom Assessment Scale (S-SAS)
timeFrame: Approximately 5-10 minutes
measure: Fantasy Checklist
timeFrame: Approximately 10-20 minutes
Other outcomes:
measure: Sociodemographic questionnaire
timeFrame: Approximately 30 minutes
Locations:
city: Ottawa
country: Canada
facility: The Royal Ottawa Health Care Group (ROHCG)
state: Ontario
Study officials:
affiliation: The Royal Ottawa Health Care Group (ROHCG)
name: John Bradford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Ottawa Health Care Group (ROHCG)
name: Dave Holmes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Ottawa Health Care Group (ROHCG)
name: Emily Tippins, MSc
role: STUDY_DIRECTOR
References: