Talking for Change Therapy for Child Sexual Abuse Prevention

Overseen By Artemis Igoumenou, M.D., Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Intellectual disability, Active psychosis, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy called Talking for Change, designed to prevent child sexual abuse by addressing individual risk factors. The trial will compare this therapy's effects with general mental health therapy and no treatment to determine which is most effective in reducing behaviors and desires linked to child sexual exploitation. Men referred due to concerns about a higher risk of offending may be suitable candidates for this trial. Participants will either engage in group psychotherapy sessions over 20 weeks or be monitored for changes without treatment.

As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could lead to more effective prevention strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Talking for Change (TFC) is a new therapy designed to prevent child sexual abuse. TFC helps individuals change behaviors and thoughts that could lead to abuse. Limited information exists about the safety of TFC because it has not been extensively tested in people. However, since this therapy does not involve medication, it is unlikely to cause physical side effects. Participants will engage in group therapy sessions, which are generally safe. Although the effects of TFC are still being studied, group therapy is a common and well-accepted method for addressing behavior issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Talking for Change" Group Psychotherapy because it specifically targets dynamic risk factors to prevent child sexual abuse, unlike general mental health therapies that do not focus on this specific risk. This approach is unique in its proactive prevention strategy, aiming to intervene before abuse occurs, rather than addressing the aftermath. By offering a focused group therapy setting, it encourages open communication and support, potentially leading to more effective prevention outcomes.

What evidence suggests that this trial's treatments could be effective for preventing child sexual abuse?

Research has shown that Talking for Change (TFC), a treatment arm in this trial, focuses on altering behaviors and thoughts that could lead to child sexual abuse. Although specific data on TFC remains limited, studies on therapy in general have demonstrated its effectiveness in reducing harmful behaviors when tailored to specific issues. Other prevention programs have successfully reduced risk factors, suggesting that targeted approaches like TFC could be effective. Early results indicate that such programs can help change harmful patterns and lower risks. ^{1 2 3 6 7}

Who Is on the Research Team?

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)

Are You a Good Fit for This Trial?

This trial is for individuals at risk of committing child sexual abuse. Participants must be willing to undergo psychotherapy and provide self-reports on their behavior and desires. Specific inclusion or exclusion criteria are not detailed, but typically such trials require participants to meet certain mental health standards.

Inclusion Criteria

For the benchmarking interview arm, participant must meet all of the following: 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.

I am 18 or older, can consent, will follow the study rules, and am referred for concerns about risks of offending against children.

Exclusion Criteria

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.

I am not male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 weeks of either the experimental TFC group psychotherapy or a control group psychotherapy targeting mental health and stress.

20 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Second Treatment

Participants may opt to participate in the second arm of the trial after completing the first treatment arm.

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Talking for Change Group Psychotherapy

Trial Overview The study tests the 'Talking for Change' group psychotherapy aimed at preventing child sexual abuse against a control therapy focused on managing stress, compared with no treatment. It lasts 20 weeks and measures reductions in risky behaviors and desires related to child sexual abuse.

How Is the Trial Designed?

Group I: Talking for Change (TFC) Group Psychotherapy Experimental Treatment 1 Intervention

Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration.

Group II: Natural History Benchmarking Active Control 1 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.

Group III: General Mental Health Group Psychotherapy Active Control 1 Intervention

The active therapeutic control is a general mental health intervention that is not specific to managing risk for child sexual abuse perpetration.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials

441

Recruited

2,157,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07001735

Talking for Change: Secondary Prevention of Child Sexual ... Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration. Intervention/Treatment ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0190740920307349

A systematic review of randomized controlled trials Thirty-two RCTs tested effectiveness of psychotherapy for child sexual abuse victims. Comparison across treatment types was difficult because outcome measures ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8024425/

Parent-Focused Sexual Abuse Prevention This study tested whether a child sexual abuse (CSA) prevention program, Smart Parents-Safe and Healthy Kids (SPSHK), could be implemented as an additional ...

4. csacentre.org.uk csacentre.org.uk/app/uploads/2023/10/Effectiveness-1-Knowledge-review.pdf

Effectiveness of services for sexually abused children and ... The Centre of expertise on child sexual abuse (CSA Centre) wants children to be able to live free from the threat and harm of sexual abuse. Our aim is to reduce ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2016.01177/full

An Evidence-Based Education Program for Adults about ... Here we describe the development of an evidence-based education program for adults about childhood sexual abuse (CSA), called Prevent It!

6. crownschool.uchicago.edu crownschool.uchicago.edu/student-life/advocates-forum/child-sexual-abuse-prevention-and-social-connection

Child Sexual Abuse Prevention and Social Connection Children who have been sexually abused may have heightened risk for experiencing several negative outcomes, including inappropriate sexual behaviors, substance ...

7. nsvrc.org nsvrc.org/sites/default/files/2012-03/Publications_NSVRC_Guide_Child-Sexual-Abuse-Prevention-programs-for-adults.txt

Publications_NSVRC_Guide_Ch... They attempt to raise awareness about the problem and help members of the public to identify signs of child sexual abuse, change their attitudes about child ...