Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Talking for Change: A Patient Preference Randomized Controlled Trial
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedStudy Start
First participant enrolled
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
June 12, 2025
June 1, 2025
1.6 years
March 24, 2025
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Violence Risk Scale - Sexual Offense Version (VRS-SO)
24 items (7 static and 17 dynamic risk factors) rated on a scale from 0 to 3; higher scores indicate higher risk; total static scores range from 0 to 21; total dynamic scores range from 0 to 51; dynamic risk factors rated 2 or 3 are designated treatment targets; each treatment target is further rated in terms of readiness for change (pre-contemplation, contemplation, preparation, action, and maintenance).
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.
Secondary Outcomes (30)
Structured Assessment of Protective Factors against Sexual Offending (SAPROF-SO)
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.
Frequency of Use of Illegal Child Sexual Abuse Imagery
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.
Frequency of Desire for Sexual Activities with Minors
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.
Frequency of Sexual Activities with Minors
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.
Coping Using Sex Inventory (CUSI)
Treatment arm: pre-treatment (within 4 weeks of starting), Treatment Week 10, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Week 1 and Week 20.
- +25 more secondary outcomes
Study Arms (3)
Natural History Benchmarking
NO INTERVENTIONA 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.
General Mental Health Group Psychotherapy
ACTIVE COMPARATORThe active therapeutic control is a general mental health intervention that is not specific to managing risk for child sexual abuse perpetration.
Talking for Change (TFC) Group Psychotherapy
EXPERIMENTALTalking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Must be deemed to have capacity to provide informed consent;
- 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.
- 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.
You may not qualify if:
- For the treatment arms:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Artemis Igoumenou, M.D., Ph.D.
Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH)
- PRINCIPAL INVESTIGATOR
Ian McPhail, Ph.D., C. Psych.
Bloomberg School of Public Health, Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Cory Gerritsen, Ph.D., C. Psych
Slaight Centre for Early Intervention, Centre for Addiction and Mental Health (CAMH)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Collaborating Scientist, Slaight Centre for Early Intervention
Study Record Dates
First Submitted
March 24, 2025
First Posted
June 3, 2025
Study Start
April 17, 2025
Primary Completion (Estimated)
November 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- For data shared through a data access agreement, beginning 3 months and ending 5 years following each article publication.
- Access Criteria
- Sharing access criteria: Investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by an independent review committee (e.g., a university ethics review board) identified for this purpose will be provided access. Types of analyses: Meta-analytic reviews, analyses that facilitate understanding of the client population and psychotherapeutic processes with these clients. How to access IPD: Proposals will be sent to ian.mcphail@jhu.edu, Artemis.Igoumenou@camh.ca, and elizabeth.letourneau@jhu.edu. To be granted access to the data, data requesters will need to sign a data access agreement. Data will be made available digitally via a secure data transfer facility provided by the Centre for Addiction and Mental Health.
Individual participant survey data will be preserved and made available via controlled access. The data shared will not contain personally identifying information. Data dictionaries will be made available via open access in Open Science Framework (OSF) and the Johns Hopkins Research Data Repository. Controlled access is being proposed to balance protecting participant data, given the sensitivity of the data collected in the study, and facilitating other researchers' access to the data.