Recruiting

TFC vs. Control

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT07001735

Conditions

Pedophilia

Hebephilia

Child Sexual Abuse

Program Evaluation

Prevention Intervention

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Talking for Change Group Psychotherapy

Healthier Me: Managing Risk and Stress in Everyday Life

Study Details

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.

Conditions

Pedophilia

Hebephilia

Child Sexual Abuse

Program Evaluation

Prevention Intervention

Study ID

NCT07001735

Start date

Apr 17, 2025

Status verified date

Jun, 2025

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Natural History Benchmarking

A subset of participants will participate in a video-conferencing interview and will complete an online survey comprising self-report measures at two time points, 20 weeks apart.

A subset of participants will complete an online survey comprising self-report measures at two time points, 20 weeks apart.

active comparator: General Mental Health Group Psychotherapy

The active therapeutic control is a general mental health intervention that is not specific to managing risk for child sexual abuse perpetration.

experimental: Talking for Change (TFC) Group Psychotherapy

Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration.

Interventions

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.

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.

Primary outcome measure

  • Violence Risk Scale - Sexual Offense Version (VRS-SO) [ Time Frame: Treatment arm: 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. ]

Central Contacts and Locations

Central contacts

Artemis Igoumenou, M.D., Ph.D.

416-535-8501artemis.igoumenou@camh.ca

Ian McPhail, Ph.D., C. Psych.

ian.mcphail@jhu.edu

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Artemis Igoumenou, M.D., Ph.D.

416-535-8501artemis.igoumenou@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Keywords

  • paraphilias
  • group psychotherapy
  • child sexual abuse
  • sexual offending against children
  • prevention
  • crime prevention
  • psychotherapy
  • dynamic risk factors
  • pedophilia
  • hebephilia
  • mechanisms of change
  • protective factors
  • individuals with sexual interest in children
  • forensic psychology
  • preventive psychiatry
  • Internet based intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2025-06-12.