NCT07001735 Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
| NCT ID | NCT07001735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Pedophilia |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2025-04-17 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
INCLUSION CRITERIA: For the treatment arms, the participant must meet all of the inclusion criteria to eligible for this clinical trial: 1. Must be deemed to have capacity to provide informed consent; 2. Must sign and date the informed consent form; 3. Stated willingness to comply with all study procedures; 4. Be 18 years of age or older upon study commencement; 5. 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: 1. Must self-report concerns about enhanced risk of sexual offending against children 2. Must be deemed to have capacity to provide informed consent; 3. Must check the appropriate box on the informed consent form; 4. Stated willingness to comply with all study procedures; 5. 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 CRITERIA: For the treatment arms: 1. Inability to engage meaningfully in group psychotherapy (e.g., due to intellectual disability, other neurodiversity, active psychosis or substance use) 2. 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). 3. Non-male sex. For the benchmarking interview arm: 1\. Non-male sex.
Contact & Investigator
Artemis Igoumenou, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH)
Frequently Asked Questions
Who can join the NCT07001735 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Pedophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07001735 currently recruiting?
Yes, NCT07001735 is actively recruiting participants. Contact the research team at artemis.igoumenou@camh.ca for enrollment information.
Where is the NCT07001735 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07001735 clinical trial?
NCT07001735 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Artemis Igoumenou, M.D., Ph.D. at Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH). The trial plans to enroll 220 participants.