Talking for Change — a program to help adults who are worried about sexually offending against children

Talking for Change: A Patient Preference Randomized Controlled Trial

This trial will see if a 20-week Talking for Change group psychotherapy helps adults who are concerned about their risk of sexually offending or accessing child sexual exploitation material reduce risk factors and harmful behaviors compared with a general mental-health group or no treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT07001735 on ClinicalTrials.gov

What this trial studies

This patient-preference randomized controlled trial compares three arms: a 20-week Talking for Change (TFC) group psychotherapy, a 20-week control group psychotherapy focused on general mental health and stress, and a no-treatment benchmarking arm. Blinded clinical raters will measure the primary outcome of reductions in dynamic risk factors for sexual offending, while participants will self-report changes in sexual contact with children, accessing child sexual exploitation material (CSEM), and sexual desire for children. Adults referred to the TFC program for concerns about elevated risk are eligible, and randomization accommodates participant preferences. The study is led by the Centre for Addiction and Mental Health in Toronto with collaboration from Johns Hopkins Bloomberg School of Public Health.

Who should consider this trial

Good fit: Adults aged 18 or older who are concerned about an elevated risk of sexually offending against children or accessing CSEM, have capacity to consent, and are referred to the TFC program are the intended participants.

Not a fit: People who require mandated tertiary offender treatment after conviction, who pose an immediate safety risk requiring legal intervention, or who cannot participate in outpatient group therapy are unlikely to benefit from this secondary-prevention program.

Why it matters

Potential benefit: If successful, the program could help at-risk adults manage factors that lead to offending and thereby reduce new incidents of child sexual abuse and online exploitation.

How similar studies have performed: Group psychotherapies for convicted sexual offenders have some evidence for reducing recidivism, but secondary-prevention programs like TFC are relatively novel and have limited prior evidence, especially in Canada.

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.

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Artemis Igoumenou, M.D., Ph.D. — Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH)
• Study coordinator: Artemis Igoumenou, M.D., Ph.D.

Conditions Pedophilia; Hebephilia; Child Sexual Abuse; Program Evaluation; Prevention Intervention; Paraphilias and Paraphilic Disorders; paraphilias; group psychotherapy