Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts

NCT ID: NCT05830643

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Paraphilias and Paraphilic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group (social skills focused psychotherapy) and control group (adult interest focused psychotherapy)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Social skills group psychotherapy

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.

Group Type EXPERIMENTAL

Social skills group psychotherapy

Intervention Type 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.

Adult interest group psychotherapy

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.

Group Type ACTIVE_COMPARATOR

Adult interest group psychotherapy

Intervention Type 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.

Interventions

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Social skills group psychotherapy

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.

Intervention Type BEHAVIORAL

Adult interest group psychotherapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral Therapy (CBT) Good Lives Model (GLM) Cognitive Behavioral Therapy (CBT) Good Lives Model (GLM)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Royal Ottawa Mental Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Bradford, MD

Role: PRINCIPAL_INVESTIGATOR

The Royal Ottawa Health Care Group (ROHCG)

Dave Holmes, PhD

Role: PRINCIPAL_INVESTIGATOR

The Royal Ottawa Health Care Group (ROHCG)

Emily Tippins, MSc

Role: STUDY_DIRECTOR

The Royal Ottawa Health Care Group (ROHCG)

Locations

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The Royal Ottawa Health Care Group (ROHCG)

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2022022

Identifier Type: -

Identifier Source: org_study_id

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