Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts

May 3, 2024 updated by: The Royal Ottawa Mental Health Centre

Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts: A Randomized Control Trial on Individuals With Problematic Sexual Interests in Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z7K4
        • The Royal Ottawa Health Care Group (ROHCG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.

Other Names:
  • Cognitive Behavioral Therapy (CBT)
  • Good Lives Model (GLM)
Active Comparator: 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.
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.

Other Names:
  • Cognitive Behavioral Therapy (CBT)
  • Good Lives Model (GLM)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Penile Plethysmography/Phallometric Testing (PPG)
Time Frame: Approximately 2.5 hours to complete, depending on the length of time needed to return to baseline levels of arousal
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social Skills Inventory (SSI)
Time Frame: Approximately 10 minutes
The brief Social Skills Inventory (SSI), also known as the Self-Description Inventory, is a 30-item Likert questionnaire that assesses 6 basic social skills that underlie social competence. It evaluates verbal (social) and non-verbal (emotional) communication skills and identifies strengths and weaknesses. As such, the SSI acts as a reliable and valid abilities measure of Emotional Intelligence.
Approximately 10 minutes
Revised Sexual Consent Scale (SCS-R)
Time Frame: Approximately 10-20 minutes
The Sexual Consent Scale-Revised (SCS-R) measures an individual's beliefs, attitudes, and behaviors with respect to how sexual consent should be and is negotiated between sexual partners. The SCS-R is a 39-item, Likert-type measure assessing both attitudes and behaviors with respect to sexual consent.
Approximately 10-20 minutes
Sexual Symptom Assessment Scale (S-SAS)
Time Frame: Approximately 5-10 minutes
In order to measure the severity of symptoms of Compulsive Sexual Behavior (CSB) the Sexual Symptom Assessment Scale (S-SAS) was developed. The S-SAS is a 12-item, self-rated scale, with each item scored 0-8; higher scores indicate more severe symptoms.
Approximately 5-10 minutes
Fantasy Checklist
Time Frame: Approximately 10-20 minutes
The fantasy checklist measures individual sexual fantasy using a 39-item, Likert scale with each item scored 0-6. Eight main factors corresponding to clearly identifiable fantasy themes have been identified (see Bradford, Curry, & Pawlak, 1996).
Approximately 10-20 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic questionnaire
Time Frame: Approximately 30 minutes
Socio-demographic information of participants will be collected from a self-report measure completed at the participant's initial assessment (Sexual Behaviours Clinic intake questionnaire).
Approximately 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Royal Ottawa Mental Health Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Bradford, MD, The Royal Ottawa Health Care Group (ROHCG)
  • Principal Investigator: Dave Holmes, PhD, The Royal Ottawa Health Care Group (ROHCG)
  • Study Director: Emily Tippins, MSc, The Royal Ottawa Health Care Group (ROHCG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All applicable data will be shared on Mendeley Data once completed. Mendeley Data is a secure online repository for research data, permitting archiving of any file type and assigning a permanent and unique digital object identifier (DOI) so that the files can be easily referenced.

IPD Sharing Time Frame

Starting February 2024.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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