Comparing Healthier Me: Managing Risk and Stress with Talking for Change Group Psychotherapy for pedophilia
Official title: Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Talking for Change: A Patient Preference Randomized Controlled Trial
- 3 groups
- One site, in Toronto
- Recruiting
Interventions
- Behavioural therapy
Talking for Change Group Psychotherapy
Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse, including (1) atypical sexual interests and sexual self-regulation problems; (2) problems in relationships; (3) offense-supportive attitudes; and (4) general self-regulation deficits and related traits (e.g., impulsivity, emotion regulation deficits). Participants will complete 20 weekly, 120-minute sessions delivered via WebEx.
- Behavioural therapy
Healthier Me: Managing Risk and Stress in Everyday Life
The active therapeutic control is a non-directive supportive psychotherapy that targets general mental health concerns. It consists of psychoeducation about human sexuality and common mental health concerns, as well as instruction and practice in applied relaxation and stress management, and group discussions that will facilitate sharing and problem-solving current stressors. This active control intervention is equivalent in length to Talking for Change (TFC), consisting of 120-minute long occurring weekly over the course of 20 weeks.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +For the treatment armsArmOne of the groups in a study, each receiving something different.Read more →, the participant must meet all of the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → to eligible for this clinical trialInterventional studyA study where participants are given something to see what happens.Read more →:
- +Must be deemed to have capacity to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →;
- +Must sign and date the informed consent form;
- +Stated willingness to comply with all study procedures;
- +Be 18 years of age or older upon study commencement;
- +Be referred for care in the TFC program due to concerns about enhanced risk of sexual offending against children.
- +For the benchmarking interview arm, the participant must meet all of the following inclusion criteria:
- +Must self-report concerns about enhanced risk of sexual offending against children
- +Must be deemed to have capacity to provide informed consent;
- +Must check the appropriate box on the informed consent form;
- +Stated willingness to comply with all study procedures;
- +Be 18 years of age or older upon study commencement.
- +For the benchmarking survey arm, participants must check the appropriate box on the informed consent form.
Exclusion
- −For the treatment armsArmOne of the groups in a study, each receiving something different.Read more →:
- −Inability to engage meaningfully in group psychotherapy (e.g., due to intellectual disability, other neurodiversity, active psychosis or substance use)
- −Those who self-identify as at-risk for reasons better accounted for by non-risk-relevant factors per clinical assessment (e.g., those with obsessive-compulsive disorder including thoughts about CSA, who commonly fear that they are at-risk but are not).
- −Non-male sex.
- −For the benchmarking interview arm:
- −\. Non-male sex.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives no study treatment and is followed for comparison.
Registry label: A: Natural History Benchmarking
Group B, the comparison group, receives Healthier Me: Managing Risk and Stress in Everyday Life.
Registry label: B: General Mental Health Group Psychotherapy
Group C receives Talking for Change Group Psychotherapy.
Registry label: C: Talking for Change (TFC) Group Psychotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists male participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 220 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Treatment armArmOne of the groups in a study, each receiving something different.Read more →: pre-treatment (within 4 weeks of starting) and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Week 1 and Week 20.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Violence Risk Scale - Sexual Offense Version (VRS-SO) — measured over Treatment armArmOne of the groups in a study, each receiving something different.Read more →: pre-treatment (within 4 weeks of starting) and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Week 1 and Week 20.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07001735 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Talking for Change Group PsychotherapyBehavioural
Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse, including (1) atypical sexual interests and sexual self-regulation problems; (2) problems in relationships; (3) offense-supportive attitudes; and (4) general self-regulation deficits and related traits (e.g., impulsivity, emotion regulation deficits). Participants will complete 20 weekly, 120-minute sessions delivered via WebEx.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About Healthier Me: Managing Risk and Stress in Everyday LifeBehavioural
The active therapeutic control is a non-directive supportive psychotherapy that targets general mental health concerns. It consists of psychoeducation about human sexuality and common mental health concerns, as well as instruction and practice in applied relaxation and stress management, and group discussions that will facilitate sharing and problem-solving current stressors. This active control intervention is equivalent in length to Talking for Change (TFC), consisting of 120-minute long occurring weekly over the course of 20 weeks.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists male participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Treatment armArmOne of the groups in a study, each receiving something different.Read more →: pre-treatment (within 4 weeks of starting) and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Week 1 and Week 20..
The study as a whole is currently expected to finish around 2026-12-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 220 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this patient preference randomized controlled trial is to investigate the efficacy of Talking for Change (TFC), an intervention for the secondary prevention of child sexual abuse and exploitation (CSA) perpetration. Blinded clinical raters will evaluate the primary endpoint-reductions in dynamic risk factors for sexual offending against children-and clients will provide self-reports to evaluate a second primary outcome-reductions in sexual contact with children, accessing online child sexual exploitation material (CSEM), and desire for sexual contact with children. Researchers will compare the following groups: (1) those receiving 20 weeks of the experimental TFC group psychotherapy; (2) those receiving 20 weeks of a control group psychotherapy targeting mental health and stress more broadly; and (3) those receiving no treatment.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.