Paraphilias and Paraphilic DisordersNCT05830643
Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts
A study testing Social skills group psychotherapy and Adult interest group psychotherapy in people with Paraphilias and Paraphilic Disorders, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Paraphilias and Paraphilic Disorders
- What is being tested?
- Social skills group psychotherapy and Adult interest group psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male (sex at birth)
- 18 years of age or older
- Understand English
- Been assessed for a question of sexual interest in children
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Royal Ottawa Health Care Group (ROHCG)
Ottawa, Ontario, K1Z7K4
About this study
Official title: 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.
Read the 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.
- Conditions
- Paraphilias and Paraphilic Disorders
- Being tested
- Social skills group psychotherapy, Adult interest group psychotherapy
- Keywords
- Paraphilias, Pedophilia, Phallometry, Group psychotherapy, Social skills, Sexual arousal, Consent
- Medical subject headings
- Paraphilic Disorders, Pedophilia, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social skills group psychotherapyBehavioural
Also called Cognitive Behavioral Therapy (CBT), Good Lives Model (GLM)
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 psychotherapyBehavioural
Also called Cognitive Behavioral Therapy (CBT), Good Lives Model (GLM)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Adult interest group psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Approximately 10 minutes
Revised Sexual Consent Scale (SCS-R)
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.
Measured: Approximately 10-20 minutes
Sexual Symptom Assessment Scale (S-SAS)
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.
Measured: Approximately 5-10 minutes
Fantasy Checklist
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).
Measured: Approximately 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start6 Feb 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraphilias and Paraphilic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group (social skills focused psychotherapy) and control group (adult interest focused psychotherapy)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Bradford, MD, Principal investigator, The Royal Ottawa Health Care Group (ROHCG)Dave Holmes, PhD, Principal investigator, The Royal Ottawa Health Care Group (ROHCG)Emily Tippins, MSc, Study director, The Royal Ottawa Health Care Group (ROHCG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830643
- Sponsor's protocol ID
- 2022022
- Status last verified
- Nov 2023
- First submitted
- 14 Apr 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Consensual Social Skills to Prevent Non-consensual Sexual Acts: A Randomized Control Trial on Individuals With Problematic Sexual Interests in Children
- ClinicalTrials.gov ID
- NCT05830643
- Acronym / sponsor ID
- 2022022
- Conditions
- Paraphilias and Paraphilic Disorders
- Keywords
- Paraphilias, Pedophilia, Phallometry, Group psychotherapy, Social skills, Sexual arousal, Consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group (social skills focused psychotherapy) and control group (adult interest focused psychotherapy)
| Arm | Type | Receives |
|---|---|---|
| Social skills group psychotherapy | Experimental | Behavioral: Social skills group psychotherapyOriginally 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. |
| Adult interest group psychotherapy | Active comparator | Behavioral: Adult interest group psychotherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male (sex at birth)
- 18 years of age or older
- Understand English
- Been assessed for a question of sexual interest in children
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social skills group psychotherapyAlso: Cognitive Behavioral Therapy (CBT), Good Lives Model (GLM)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. | Behavioural | Social skills group psychotherapy |
| Adult interest group psychotherapyAlso: Cognitive Behavioral Therapy (CBT), Good Lives Model (GLM)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. | Behavioural | Adult interest group psychotherapy |
Primary outcome
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.
4 secondary outcomes
Social Skills Inventory (SSI)
Time frame: Approximately 10 minutes
Revised Sexual Consent Scale (SCS-R)
Time frame: Approximately 10-20 minutes
Sexual Symptom Assessment Scale (S-SAS)
Time frame: Approximately 5-10 minutes
Fantasy Checklist
Time frame: Approximately 10-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Pedophilia, Hebephilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Bradford, MD principal investigator
The Royal Ottawa Health Care Group (ROHCG)
Dave Holmes, PhD principal investigator
The Royal Ottawa Health Care Group (ROHCG)
Emily Tippins, MSc study director
The Royal Ottawa Health Care Group (ROHCG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social skills group psychotherapy and Adult interest group psychotherapy in people with Paraphilias and Paraphilic Disorders, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.