Talking for Change: A Patient Preference Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Violence Risk Scale - Sexual Offense Version (VRS-SO)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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:
- •Non-male sex.
研究组 & 干预措施
Natural History Benchmarking
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
The active therapeutic control is a general mental health intervention that is not specific to managing risk for child sexual abuse perpetration.
干预措施: Healthier Me: Managing Risk and Stress in Everyday Life (Behavioral)
Talking for Change (TFC) Group Psychotherapy
Talking for Change (TFC) is a secondary prevention program that targets dynamic risk factors for child sexual abuse perpetration.
干预措施: Talking for Change Group Psychotherapy (Behavioral)
结局指标
主要结局
Violence Risk Scale - Sexual Offense Version (VRS-SO)
时间窗: 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).
次要结局
- Structured Assessment of Protective Factors against Sexual Offending (SAPROF-SO)(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(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(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(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.)
- Children and Sex Questionnaire: Emotional Congruence with Children(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.)
- Curative Climate Instrument (CCI)(Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.)
- Coping Using Sex Inventory (CUSI)(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)(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)(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)(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(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.)
- Group Questionnaire - 12(Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.)
- Trust and Respect for Clinician Scale (TRCS)(Treatment Weeks 1 and 7. Repeated for the second treatment.)
- The Multitheoretical List of Therapeutic Interventions 30(Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.)
- Aggression Inventory (AI)(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)(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)(Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.)
- Clinical Outcomes in Routine Evaluation -10 (CORE-10)(Weekly over the course of the 20 treatment weeks. Repeated for the second treatment.)
- Group Climate Questionnaire - Short Form (GCQ-S)(Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.)
- Treatment Motivation Questionnaire - Revised (TMQ-R)(Pre-treatment (within four weeks of starting) and at Treatment Week 3. Repeated for the second treatment.)
- Therapeutic Factors Inventory - Short Form(Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.)
- Therapeutic Agency Inventory (TAI)(Treatment Weeks 1, 7, 14 and 20. Repeated for the second treatment.)
- Relationship Questionnaire (RQ)(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)(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)(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)(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)(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(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(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(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.)
研究者
Cory Gerritsen
Collaborating Scientist, Slaight Centre for Early Intervention
Centre for Addiction and Mental Health