PedophiliaNCT07001735
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
A study testing Talking for Change Group Psychotherapy and Healthier Me: Managing Risk and Stress in Everyday Life in people with Pedophilia and Hebephilia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pedophilia, Hebephilia, Child Sexual Abuse
- What is being tested?
- Talking for Change Group Psychotherapy and Healthier Me: Managing Risk and Stress in Everyday Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the treatment arms, the participant must meet all of the inclusion criteria to eligible for this clinical trial:
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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:
- 1. Non-male sex.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ian McPhail, Ph.D., C. Psych. contact
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Artemis Igoumenou, M.D., Ph.D., 416-535-8501 ext. 32389, artemis.igoumenou@camh.ca
About this study
Official title: Talking for Change: A Patient Preference Randomized Controlled 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.
Read the detailed description
Child sexual abuse (CSA) is a preventable public health issue that has significant mental health, physical health, financial, societal, and personal consequences. In Canada, perpetration prevention interventions are typically provided after CSA has occurred and its damaging sequelae have already occurred (i.e., tertiary prevention interventions are provided to those already convicted to prevent re-offending). These tertiary prevention interventions are reactive in nature and represent one form of the prevention spectrum.
One approach to CSA perpetration prevention that has been historically neglected in Canada is secondary prevention. Secondary CSA perpetration prevention interventions aim to prevent the onset of CSA perpetration by targeting populations that are at elevated risk. These interventions focus on helping at-risk adults understand and manage psychosocial risk factors that are causes of CSA perpetration. By targeting these risk factors, secondary perpetration prevention treatment programs help at-risk individuals live offense-free lives. At present, there is a lack of data on whether secondary CSA perpetration prevention programs are efficacious in reducing CSA perpetration.
Talking for Change (TFC) is a secondary CSA perpetration prevention intervention offering psychotherapy to adults who are concerned about their risk of perpetrating CSA or accessing online child sexual exploitation material (CSEM). The target client population of TFC are adults with a sexual interest in children, those who self-identify as being at-risk of viewing CSEM, or those who self-identify as at-risk of having sexual contact with children. TFC targets dynamic risk factors that are the causes of engaging in CSA or accessing CSEM, 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).
The primary objective of the proposed research is to examine the efficacy of TFC via a patient preference randomized controlled trial to test superiority over (a) active psychological control and (b) no-treatment control arms. More specifically, the present trial aims to understand whether TFC produces significantly greater improvement in established risk factors for CSA perpetration and reductions in CSA behavior compared to the two control arms.
The secondary objectives of the research are to examine additional outcomes (including quality of life and treatment indicators) and examine mediators of treatment change. These secondary outcomes will allow for a more fulsome understanding of the effects of TFC and insight into mechanisms of change in TFC.
This is a single-blind patient preference randomized controlled trial of TFC versus active control, with a third non-randomly allocated no treatment control arm (i.e., a natural history benchmarking arm). Briefly, eligible clients referred to TFC who consent to participate in the trial will first be asked if they are willing to be randomized into one of the two trial treatment arms. Those who decline to be randomized will enter the study arm they prefer. The advantage of this approach is that it can accommodate the methodological rigor associated with a randomized clinical trial while reducing trial non-participation among those with a strong treatment preference. Once clients complete one arm of the trial, they will be offered the opportunity to participate in the second arm of the trial. In either case, continuation into the alternate intervention will be optional as will the continued collection of study data.
Benchmarking for natural history processes will involve data collection on online forums for individuals with pedohebephilic interests (i.e., those with an attraction to prepubescent and pubescent minors). Participants in the benchmarking arm will be involved in two assessment time points over the course of 20 weeks, which will allow for estimating change on primary and secondary outcomes over a period of time equivalent to the duration of the TFC and control treatment arms of the trial. Inclusion of a benchmarking sample allows the researchers to compare the effect of TFC to natural history processes (e.g., maturation, the passage of time).
Two groups of benchmarking participants will be recruited, with participants in the two groups receiving a different assessment battery. The first group will complete an online survey of self-report measures and a psychosocial interview focused on risk factors for sexual offending and protective factors. Once an adequate number of benchmarking participants have completed an interview, recruited participants will complete only the online survey containing self-report measures. The decision to use this stopping rule for the benchmarking arm was based on power analyses using effect size data from a pilot evaluation of the TFC program.
- Conditions
- Pedophilia, Hebephilia, Child Sexual Abuse, Program Evaluation, Prevention Intervention, Paraphilias and Paraphilic Disorders
- Being tested
- Talking for Change Group Psychotherapy, Healthier Me: Managing Risk and Stress in Everyday Life
- 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
- Medical subject headings
- Pedophilia, Paraphilic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Natural History Benchmarking | No intervention | 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. |
| General Mental Health Group Psychotherapy | Active comparator | The active therapeutic control is a general mental health intervention that is not specific to managing risk for child sexual abuse perpetration. Receives: Behavioral: Healthier Me: Managing Risk and Stress in Everyday Life |
| Talking for Change (TFC) Group Psychotherapy | Experimental | Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration. Receives: Behavioral: Talking for Change Group Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
14 items (and 6 additional optional items) rated on a scale from 0 to 4; higher scores indicate greater presence of the protective factor; total scores range from 0 to 56 (80, if the optional items are included).
Measured: 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
4 items rated on a 5-point Likert scale; higher scores indicate more frequent consumption of sexual imagery of children; total scores range from 4 to 20.
Measured: 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
4 items rated on a 5-point Likert scale; higher scores indicate greater desire to engage in sexual contact with minors; total scores range from 4 to 20.
Measured: 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
3 items on a 5-point Likert scale; higher scores indicate greater frequency of one's sexual contact with minors; total scores range from 3 to 15.
Measured: 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)
8 CUSI items, rated on a 5-point Likert scale, will be used in this trial; higher scores indicate greater tendency to use sex to cope with problematic situations; total scores range from 8 to 40.
Measured: 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.
Compulsive Sexual Behavior Inventory - 13 (CSBI)
13 items rated on a 5-point Likert scale; higher scores indicate greater sexual compulsivity; total scores range from 13 to 65.
Measured: 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.
Cognitions that Support Sexual Offending Against Children Scale - Short Form (CSSOC-SF)
10 items rated on a 4-point Likert scale; higher scores indicate greater endorsement of cognitions that support and condone sexual offending; total scores range from 10 to 40.
Measured: Treatment arms: 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.
Children and Sex Questionnaire: Emotional Congruence with Children
3 items from this scale, rated on a 4-point Likert scale, will be used in this trial; higher scores reflect greater emotional congruence with children; total scores range from 3 to 12.
Measured: Treatment arms: 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.
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
18 items rated on a 5-point Likert scale; higher scores indicate greater difficulties with emotion regulation; total scores range from 18 to 90.
Measured: Treatment arms: 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: Weeks 1 and 20.
Aggression Inventory (AI)
9 items rated on a 5-point Likert scale; higher scores indicate greater aggression; total scores range from 9 to 45.
Measured: Treatment arms: 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: Weeks 1 and 20.
Brief Aggression Questionnaire (BAQ)
6 items from this measure, rated on a 7-point Likert scale, will be used in this trial; higher scores indicate greater aggression; total scores range from 6 to 42.
Measured: Treatment arms: 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: Weeks 1 and 20.
Problems in Interpersonal Relationships
22 items rated on a 4- to 7-point Likert scale; higher scores indicate greater loneliness, social isolation, and experience of jealousy in intimate relationships; total scores range from 22 to 134.
Measured: Treatment arms: 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: Weeks 1 and 20.
Dimensions of Skillfulness and Use Scale (DSUS)
4 items rated on a 5-point Likert scale; higher scores indicate greater understanding and use of skills learned in the session; total scores range from 4 to 20.
Measured: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
Clinical Outcomes in Routine Evaluation -10 (CORE-10)
10 items rated on a 5-point Likert scale; higher scores indicate more problems with psychological symptoms, functional impairment, and risk to self; total scores range from 0 to 40.
Measured: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
The Multitheoretical List of Therapeutic Interventions 30
30 items rated on a 5-point Likert scale; higher scores indicate higher quality and intensity of interventions provided during therapy sessions; total scores range from 30 to 150.
Measured: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
Curative Climate Instrument (CCI)
9 items rated on a 4-point Likert scale; higher scores indicate greater presence of therapeutic factors; total scores range from 9 to 36.
Measured: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Group Climate Questionnaire - Short Form (GCQ-S)
12 items rated on a 7-point Likert scale; higher scores indicate a more favorable perception of the group therapeutic environment; total scores range from 0 to 72.
Measured: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Treatment Motivation Questionnaire - Revised (TMQ-R)
19 items rated on a 7-point Likert scale; higher scores indicate greater motivation to participate in treatment; total scores range from 19 to 133.
Measured: Pre-treatment (within four weeks of starting) and at Treatment Week 3. Repeated for the second treatment.
Group Questionnaire - 12
4 items from this scale, rated on a 7-point Likert scale, will be used in this trial; higher scores indicate a more positive experience in the therapy group; total scores range from 0 to 24.
Measured: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Trust and Respect for Clinician Scale (TRCS)
8 items from this scale, rated on a 7-point Likert scale, will be used in this trial; higher scores indicate greater level of trust and respect for the clinician; total scores range from 8 to 56.
Measured: Treatment Weeks 1 and 7. Repeated for the second treatment.
Therapeutic Factors Inventory - Short Form
13 items from this scale, rated on a 7-point Likert scale, will be used in this trial; higher scores indicate stronger perceptions of four therapeutic factors (instillation of hope, secure emotional expression, awareness of relational impact, and social learning); total scores range from 13 to 91.
Measured: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Therapeutic Agency Inventory (TAI)
10 TAI items, rated on a 5-point Likert scale, will be used in this trial; higher scores indicate more experience of agency in therapy; total scores range from 10 to 50.
Measured: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Relationship Questionnaire (RQ)
4 items rated on a 7-point scale; higher scores on each item indicate greater identification with the attachment style the item describes; scores for each attachment style range from 1 to 7.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting). Repeated for the second treatment. Benchmarking arm: Week 1.
Forms of Self-Criticizing & Self-Reassuring Scale - Short Form (FSCRS-SF)
14 items rated on a 5-point Likert scale; higher scores indicate a greater sense of inadequacy (scores range from 0 to 20), self-hate (scores range from 0 to 16), and self-reassurance (score scores range from 0 to 20).
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Multidimensional Psychological Flexibility Inventory (MPFI)
45 items from this scale, rated on a 6-point Likert scale, will be used in this trial; higher scores reflect greater psychological flexibility; total scores range from 45 to 270.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Coping Strategy Indicator Short Form (CSI-SF)
18 items rated on a 3-point Likert scale; higher scores reflect a greater tendency to cope using problem-solving, seeking social support, or avoidance; total scores range from 18 to 54.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
CBT Suitability Scale (CBT-SUITS)
13 items rated on a 5-point Likert scale; higher scores indicate greater beliefs and attitudes consistent with cognitive behavioral therapy; total scores range from 13 to 65.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Cognitive and Behavioral Response to Stress Scale
6 items from this scale, rated on a 7-point Likert scale, will be used in this trial; higher scores indicate more frequent cognitive and behavioral responses to stressful or upsetting situations; total scores range from 0 to 36.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
General Self-Efficacy Scale
10 items rated on a 4-point Likert scale; higher scores indicate greater self-efficacy; scores range from 10 to 40.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Experience, Understanding, and Management of Risk-Relevant Sexuality
12 items rated on a 7-point Likert scale; higher scores reflect greater ability to manage one's sexual arousal and behavior in one's daily life; total scores range from 12 to 84.
Measured: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start17 Apr 2025
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-armed preference trial with active psychological placebo control and non-randomized no-intervention control arm; placebo control participants will receive experimental treatment after placebo and vice-versa
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Principal investigator, Cory Gerritsen, Centre for Addiction and Mental Health
- Investigators
- Artemis Igoumenou, M.D., Ph.D., Principal investigator, Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH)Ian McPhail, Ph.D., C. Psych., Principal investigator, Bloomberg School of Public Health, Johns Hopkins UniversityCory Gerritsen, Ph.D., C. Psych, Principal investigator, Slaight Centre for Early Intervention, Centre for Addiction and Mental Health (CAMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001735
- Sponsor's protocol ID
- 2024/178
- Status last verified
- Jun 2025
- First submitted
- 24 Mar 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Talking for Change: A Patient Preference Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07001735
- Acronym / sponsor ID
- 2024/178
- Conditions
- Pedophilia, Hebephilia, Child Sexual Abuse, Program Evaluation, Prevention Intervention, Paraphilias and Paraphilic Disorders
- Keywords
- paraphilias, group psychotherapy, child sexual abuse, sexual offending against children, prevention, crime prevention, psychotherapy, dynamic risk factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Child sexual abuse (CSA) is a preventable public health issue that has significant mental health, physical health, financial, societal, and personal consequences. In Canada, perpetration prevention interventions are typically provided after CSA has occurred and its damaging sequelae have already occurred (i.e., tertiary prevention interventions are provided to those already convicted to prevent re-offending). These tertiary prevention interventions are reactive in nature and represent one form of the prevention spectrum.
One approach to CSA perpetration prevention that has been historically neglected in Canada is secondary prevention. Secondary CSA perpetration prevention interventions aim to prevent the onset of CSA perpetration by targeting populations that are at elevated risk. These interventions focus on helping at-risk adults understand and manage psychosocial risk factors that are causes of CSA perpetration. By targeting these risk factors, secondary perpetration prevention treatment programs help at-risk individuals live offense-free lives. At present, there is a lack of data on whether secondary CSA perpetration prevention programs are efficacious in reducing CSA perpetration.
Talking for Change (TFC) is a secondary CSA perpetration prevention intervention offering psychotherapy to adults who are concerned about their risk of perpetrating CSA or accessing online child sexual exploitation material (CSEM). The target client population of TFC are adults with a sexual interest in children, those who self-identify as being at-risk of viewing CSEM, or those who self-identify as at-risk of having sexual contact with children. TFC targets dynamic risk factors that are the causes of engaging in CSA or accessing CSEM, 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).
The primary objective of the proposed research is to examine the efficacy of TFC via a patient preference randomized controlled trial to test superiority over (a) active psychological control and (b) no-treatment control arms. More specifically, the present trial aims to understand whether TFC produces significantly greater improvement in established risk factors for CSA perpetration and reductions in CSA behavior compared to the two control arms.
The secondary objectives of the research are to examine additional outcomes (including quality of life and treatment indicators) and examine mediators of treatment change. These secondary outcomes will allow for a more fulsome understanding of the effects of TFC and insight into mechanisms of change in TFC.
This is a single-blind patient preference randomized controlled trial of TFC versus active control, with a third non-randomly allocated no treatment control arm (i.e., a natural history benchmarking arm). Briefly, eligible clients referred to TFC who consent to participate in the trial will first be asked if they are willing to be randomized into one of the two trial treatment arms. Those who decline to be randomized will enter the study arm they prefer. The advantage of this approach is that it can accommodate the methodological rigor associated with a randomized clinical trial while reducing trial non-participation among those with a strong treatment preference. Once clients complete one arm of the trial, they will be offered the opportunity to participate in the second arm of the trial. In either case, continuation into the alternate intervention will be optional as will the continued collection of study data.
Benchmarking for natural history processes will involve data collection on online forums for individuals with pedohebephilic interests (i.e., those with an attraction to prepubescent and pubescent minors). Participants in the benchmarking arm will be involved in two assessment time points over the course of 20 weeks, which will allow for estimating change on primary and secondary outcomes over a period of time equivalent to the duration of the TFC and control treatment arms of the trial. Inclusion of a benchmarking sample allows the researchers to compare the effect of TFC to natural history processes (e.g., maturation, the passage of time).
Two groups of benchmarking participants will be recruited, with participants in the two groups receiving a different assessment battery. The first group will complete an online survey of self-report measures and a psychosocial interview focused on risk factors for sexual offending and protective factors. Once an adequate number of benchmarking participants have completed an interview, recruited participants will complete only the online survey containing self-report measures. The decision to use this stopping rule for the benchmarking arm was based on power analyses using effect size data from a pilot evaluation of the TFC program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-armed preference trial with active psychological placebo control and non-randomized no-intervention control arm; placebo control participants will receive experimental treatment after placebo and vice-versa
| Arm | Type | Receives |
|---|---|---|
| Natural History Benchmarking | No intervention | –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. |
| General Mental Health Group Psychotherapy | Active comparator | Behavioral: Healthier Me: Managing Risk and Stress in Everyday LifeThe 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 | Experimental | Behavioral: Talking for Change Group PsychotherapyTalking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For the treatment arms, the participant must meet all of the inclusion criteria to eligible for this clinical trial:
- 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;
Key exclusion criteria (6 listed)
- 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.
- 1. Non-male sex.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking for Change Group PsychotherapyTalking 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 | Talking for Change (TFC) Group Psychotherapy |
| Healthier Me: Managing Risk and Stress in Everyday LifeThe 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. | Behavioural | General Mental Health Group Psychotherapy |
Primary outcome
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.
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).
30 secondary outcomes
Structured Assessment of Protective Factors against Sexual Offending (SAPROF-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.
Frequency of Use of Illegal Child Sexual Abuse Imagery
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.
Frequency of Desire for Sexual Activities with Minors
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.
Frequency of Sexual Activities with Minors
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.
Coping Using Sex Inventory (CUSI)
Time frame: 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.
Compulsive Sexual Behavior Inventory - 13 (CSBI)
Time frame: 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.
Cognitions that Support Sexual Offending Against Children Scale - Short Form (CSSOC-SF)
Time frame: Treatment arms: 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.
Children and Sex Questionnaire: Emotional Congruence with Children
Time frame: Treatment arms: 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.
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Time frame: Treatment arms: 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: Weeks 1 and 20.
Aggression Inventory (AI)
Time frame: Treatment arms: 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: Weeks 1 and 20.
Brief Aggression Questionnaire (BAQ)
Time frame: Treatment arms: 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: Weeks 1 and 20.
Problems in Interpersonal Relationships
Time frame: Treatment arms: 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: Weeks 1 and 20.
Dimensions of Skillfulness and Use Scale (DSUS)
Time frame: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
Clinical Outcomes in Routine Evaluation -10 (CORE-10)
Time frame: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
The Multitheoretical List of Therapeutic Interventions 30
Time frame: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
Curative Climate Instrument (CCI)
Time frame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Group Climate Questionnaire - Short Form (GCQ-S)
Time frame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Treatment Motivation Questionnaire - Revised (TMQ-R)
Time frame: Pre-treatment (within four weeks of starting) and at Treatment Week 3. Repeated for the second treatment.
Group Questionnaire - 12
Time frame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Trust and Respect for Clinician Scale (TRCS)
Time frame: Treatment Weeks 1 and 7. Repeated for the second treatment.
Therapeutic Factors Inventory - Short Form
Time frame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Therapeutic Agency Inventory (TAI)
Time frame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
Relationship Questionnaire (RQ)
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting). Repeated for the second treatment. Benchmarking arm: Week 1.
Forms of Self-Criticizing & Self-Reassuring Scale - Short Form (FSCRS-SF)
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Multidimensional Psychological Flexibility Inventory (MPFI)
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Coping Strategy Indicator Short Form (CSI-SF)
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
CBT Suitability Scale (CBT-SUITS)
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Cognitive and Behavioral Response to Stress Scale
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
General Self-Efficacy Scale
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Experience, Understanding, and Management of Risk-Relevant Sexuality
Time frame: Treatment arms: pre-treatment (within 4 weeks of starting), Treatment Week 7, Treatment Week 14, and post-treatment (within 4 weeks of completing). Repeated for the second treatment. Benchmarking arm: Weeks 1 and 20.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Pedophilia
Recruiting
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
Partner
Recruiting
Troubled-Desire & Therapeutic Chat for Reduction of CSAM Use (TD-CHAT)
Prevention, Well Being
Recruiting
ReDirection / Self-Guided ICBT to Reduce the Risk of Child Sexual Abuse Material (CSAM) Use
Pedophilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian McPhail, Ph.D., C. Psych. contact
Artemis Igoumenou, M.D., Ph.D. principal investigator
Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH)
Ian McPhail, Ph.D., C. Psych. principal investigator
Bloomberg School of Public Health, Johns Hopkins University
Cory Gerritsen, Ph.D., C. Psych principal investigator
Slaight Centre for Early Intervention, Centre for Addiction and Mental Health (CAMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talking for Change Group Psychotherapy and Healthier Me: Managing Risk and Stress in Everyday Life in people with Pedophilia and Hebephilia, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artemis Igoumenou, M.D., Ph.D. (416-535-8501 ext. 32389, artemis.igoumenou@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.