Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts

NCT05830643 | Enrolling By Invitation

• 1 other identifier: 2022022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraphilias and Paraphilic Disorders

Keywords

Paraphilias; Pedophilia; Phallometry; Group psychotherapy; Social skills; Sexual arousal; Consent

Outcome Measures

Primary Outcomes (1)

• Penile Plethysmography/Phallometric Testing (PPG)

  Objective measure of sexual arousal. Phallometry involves the physiological measurement of penile tumescence (i.e., erection) in response to various stimuli, such as audio descriptions of child and adult sexual interactions or pictures of nude or semi-clothed children and adults.

  Approximately 2.5 hours to complete, depending on the length of time needed to return to baseline levels of arousal

Secondary Outcomes (4)

• Social Skills Inventory (SSI)

  Approximately 10 minutes

• Revised Sexual Consent Scale (SCS-R)

  Approximately 10-20 minutes

• Sexual Symptom Assessment Scale (S-SAS)

  Approximately 5-10 minutes

• Fantasy Checklist

  Approximately 10-20 minutes

Other Outcomes (1)

• Sociodemographic questionnaire

  Approximately 30 minutes

Study Arms (2)

Social skills group psychotherapy

EXPERIMENTAL

Originally designed to meet the needs of patients with ASD or ASPD, this group is now popular with patients who want to work on issues involving their relationships with their probation or parole officers or in establishing health romantic relationships.

Behavioral: Social skills group psychotherapy

Adult interest group psychotherapy

ACTIVE COMPARATOR

The adult interest group has dual aims to (1) stop illegal sex acts and (2) enhance noncriminal sexual interests. The group focuses on respect for informed, voluntary, revocable, consent by examining various cognitive distortions that group members may endorse.

Behavioral: Adult interest group psychotherapy

Interventions

Social skills group psychotherapy BEHAVIORAL

Groups are 1.5-hours and facilitated by a psychiatrist and social worker. The groups follow Cognitive Behavioral Therapy (CBT) and the Good Lives Model (GLM). Groups involve a check-in to receive advice from group members and then revolve around 1-2 topics. The facilitators are responsible for asking probing questions about the topic to facilitate group discussion and learning. CBT treatment involves efforts to change thinking patterns which might include: Learning to recognize one's distortions in thinking that are creating problems, and then to re-evaluate them. Gaining a better understanding of the behavior and motivation of others. Using problem-solving skills to cope with difficult situations. GLM conceptualized healthy sexuality as the natural outcome of success in achieving life goals. Some patients have difficulty changing their self-identity from that of "sex offender" to that of "former sex-offender". The GLM principles are helpful in achieving this aim.

Also known as: Cognitive Behavioral Therapy (CBT), Good Lives Model (GLM)

Social skills group psychotherapy

Adult interest group psychotherapy BEHAVIORAL

Groups are 1.5-hours and facilitated by a psychiatrist and social worker. The groups follow Cognitive Behavioral Therapy (CBT) and the Good Lives Model (GLM). Groups involve a check-in to receive advice from group members and then revolve around 1-2 topics. The facilitators are responsible for asking probing questions about the topic to facilitate group discussion and learning. CBT treatment involves efforts to change thinking patterns which might include: Learning to recognize one's distortions in thinking that are creating problems, and then to re-evaluate them. Gaining a better understanding of the behavior and motivation of others. Using problem-solving skills to cope with difficult situations. GLM conceptualized healthy sexuality as the natural outcome of success in achieving life goals. Some patients have difficulty changing their self-identity from that of "sex offender" to that of "former sex-offender". The GLM principles are helpful in achieving this aim.

Also known as: Cognitive Behavioral Therapy (CBT), Good Lives Model (GLM)

Adult interest group psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Considering that a requirement for phallometric testing (which is the primary outcome tool used in the proposed study) is for the participant to have a penis, biological women will be excluded from this study. This does not include biological men who present their gender identity as female. While there is a test of objective sexual arousal designed for biological women (i.e., vaginal photoplethysmography, VPP), this method of measurement will not be used in the following study due to issues of validity with this measurement tool, as well as the difficulty in comparing the two methods of measurement. We recognize that women and adolescents of both genders also commit sex offences, however, in this study we plan to focus on the segment of the population at most risk of offending, adult males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

The Royal Ottawa Health Care Group (ROHCG)

Ottawa, Ontario, K1Z7K4, Canada

Location

MeSH Terms

Conditions

Paraphilic Disorders; Pedophilia; Social Skills

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John Bradford, MD

  The Royal Ottawa Health Care Group (ROHCG)

  PRINCIPAL INVESTIGATOR

• Dave Holmes, PhD

  The Royal Ottawa Health Care Group (ROHCG)

  PRINCIPAL INVESTIGATOR

• Emily Tippins, MSc

  The Royal Ottawa Health Care Group (ROHCG)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A Prospective Randomized Open, Blinded End-point (PROBE) design will occur. The end-points are evaluated by a blinded end-point clinical coordinator therefore there should be no different between the two types of trials in this regard.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group (social skills focused psychotherapy) and control group (adult interest focused psychotherapy)

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: February 6, 2023
• Primary Completion: January 30, 2025
• Study Completion: March 31, 2026
• Last Updated: May 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting February 2024.

Locations

CA (1)