Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-02-20 @ 6:37 PM
Study NCT ID:
NCT07001735
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Sponsor:
Centre for Addiction and Mental Health
Organization:
Study Overview
Official Title:
Talking for Change: A Patient Preference Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: