About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Talking for Change Group Psychotherapy
BehavioralTalking 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
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.
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.
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.
Sponsors and contacts
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Centre for Addiction and Mental Health
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborator