Clinical trial NCT07001735: Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Official title: Talking for Change: A Patient Preference Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
pedophilia
hebephilia
mechanisms of change
protective factors
individuals with sexual interest in children
forensic psychology
preventive psychiatry
Internet based intervention
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
First posted: 2025-06-03
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Violence Risk Scale - Sexual Offense Version (VRS-SO)
timeFrame: 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:
measure: Structured Assessment of Protective Factors against Sexual Offending (SAPROF-SO)
timeFrame: 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.
measure: Frequency of Use of Illegal Child Sexual Abuse Imagery
timeFrame: 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.
measure: Frequency of Desire for Sexual Activities with Minors
timeFrame: 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.
measure: Frequency of Sexual Activities with Minors
timeFrame: 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.
measure: Coping Using Sex Inventory (CUSI)
timeFrame: 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.
measure: Compulsive Sexual Behavior Inventory - 13 (CSBI)
timeFrame: 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.
measure: Cognitions that Support Sexual Offending Against Children Scale - Short Form (CSSOC-SF)
timeFrame: 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.
measure: Children and Sex Questionnaire: Emotional Congruence with Children
timeFrame: 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.
measure: Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
timeFrame: 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.
measure: Aggression Inventory (AI)
timeFrame: 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.
measure: Brief Aggression Questionnaire (BAQ)
timeFrame: 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.
measure: Problems in Interpersonal Relationships
timeFrame: 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.
measure: Dimensions of Skillfulness and Use Scale (DSUS)
timeFrame: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
measure: Clinical Outcomes in Routine Evaluation -10 (CORE-10)
timeFrame: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
measure: The Multitheoretical List of Therapeutic Interventions 30
timeFrame: Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.
measure: Curative Climate Instrument (CCI)
timeFrame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
measure: Group Climate Questionnaire - Short Form (GCQ-S)
timeFrame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
measure: Treatment Motivation Questionnaire - Revised (TMQ-R)
timeFrame: Pre-treatment (within four weeks of starting) and at Treatment Week 3. Repeated for the second treatment.
measure: Group Questionnaire - 12
timeFrame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
measure: Trust and Respect for Clinician Scale (TRCS)
timeFrame: Treatment Weeks 1 and 7. Repeated for the second treatment.
measure: Therapeutic Factors Inventory - Short Form
timeFrame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
measure: Therapeutic Agency Inventory (TAI)
timeFrame: Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.
measure: Relationship Questionnaire (RQ)
timeFrame: Treatment arms: pre-treatment (within 4 weeks of starting). Repeated for the second treatment. Benchmarking arm: Week 1.
measure: Forms of Self-Criticizing & Self-Reassuring Scale - Short Form (FSCRS-SF)
timeFrame: 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.
measure: Multidimensional Psychological Flexibility Inventory (MPFI)
timeFrame: 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.
measure: Coping Strategy Indicator Short Form (CSI-SF)
timeFrame: 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.
measure: CBT Suitability Scale (CBT-SUITS)
timeFrame: 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.
measure: Cognitive and Behavioral Response to Stress Scale
timeFrame: 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.
measure: General Self-Efficacy Scale
timeFrame: 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.
measure: Experience, Understanding, and Management of Risk-Relevant Sexuality
timeFrame: 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.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Complex Care and Recovery Program, Centre for Addiction and Mental Health (CAMH)
name: Artemis Igoumenou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bloomberg School of Public Health, Johns Hopkins University
name: Ian McPhail, Ph.D., C. Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Slaight Centre for Early Intervention, Centre for Addiction and Mental Health (CAMH)
name: Cory Gerritsen, Ph.D., C. Psych
role: PRINCIPAL_INVESTIGATOR
References: