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临床试验/NCT06300957
NCT06300957已完成不适用

Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2023年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
147
试验地点
1
主要终点
Sexual Behavior Involving Minors Scale (SBIMS).

研究概览

简要总结

This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential.

详细描述

The study seeks to conduct a randomized controlled trial (RCT) to evaluate the Help Wanted Prevention Intervention (Help Wanted). Help Wanted is a novel, online, self-paced intervention designed to support the needs of people with a sexual attraction to children, who wish to keep children and themselves safe. The intervention includes an introductory welcome place, five training sessions that deliver core intervention content, and a resources page that provides links to external sources of support.

The RCT will be conducted in two phases to a) evaluate the effects of Help Wanted on child sexual abuse offense behaviors, grooming behaviors, and proclivity to offend, as well as the impact on targeted psychosocial stressors that are associated with child sexual abuse perpetration; and b) examine psychosocial stressors both as outcome measures and as potential mediators and moderators.

In phase one, the investigators will beta-test RCT study procedures with a sample of adults with a sexual attraction to children who have never abused a child (N = 10). Participants in this phase will be asked to:

  1. Provide a non-identifying email address to receive correspondence from the study team and verify the correspondence is working (i.e., reminders to complete assessments, a link to access study surveys and Help Wanted)..
  2. Complete the pre-intervention survey (approximately 20-30 minutes).
  3. Complete (i.e., click through) each of the five Help Wanted sessions and review the resources page.
  4. Complete the post-intervention survey (approximately 20-30 minutes).
  5. Participate in a 30-60-minute anonymous audio call (e.g., Zoom) with a member of the study team to discuss their feedback on the study procedures. These calls will be scheduled between the participant and a study staff using the participant's non-identifying email address and will take place over an online platform such as Zoom that allows participants to take part in an audio-only meeting by only providing their non-identifying email address. When using an online audio call platform, anonymity of participants will be protected by disabling video and no personal identifiable information will be collected during the call. Calls will be audio-recorded and transcribed to ensure that concerns are accurately captured and addressed as needed.

The pre-intervention and post-intervention surveys contain all survey measures so the investigators will not require beta participants to complete the additional survey (i.e., the 1-month post-intervention survey), which includes only a portion of the measures in the pre- and post-intervention surveys. Information gathered from beta participants will only inform changes to the study procedures before launching phase two of the RCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men (cis-gender and transgender)
  • Age 18 and older (no upper age limit)
  • Self-identified sexual attraction to prepubescent or early pubescent children
  • No prior contact offense with a child
  • Never accessed the Help Wanted intervention.

排除标准

  • Women (cis-gender and transgender)
  • Under age 18
  • No sexual attraction to prepubescent or early pubescent children
  • Any prior contact offense with a child
  • Previously accessed the Help Wanted intervention

研究组 & 干预措施

Intervention

Experimental

Participants will be randomly assigned 2:1 to Experimental or Waitlist Control conditions. Experimental group will immediately access "Help Wanted", a secondary prevention program for adults who self-identify as having sexual attraction to children. Help Wanted is an online self-help curriculum to prevent Child Sexual Abuse (CSA) and reduce the psychosocial stressors of help-seekers. Content is designed to increase knowledge about CSA, counter distorted attitudes and cognitions, cope with sexual thoughts and urges about children, support development of a healthy sexuality, counter stigma and shame, build a positive self-image, and encourage safe disclosure practices. Harm and risks are clearly identified within an overall positive messaging framework. Help Wanted incorporates testimonials from survivors and from positive role models, avoids the collection of personal identifiers or reportable information, and adheres to other best practices of prevention programming.

干预措施: Help Wanted Prevention Intervention (Other)

Waitlist Control

Other

Participants randomized to the Waitlist Control group will be barred from accessing the Help Wanted program for a period of one month.

干预措施: Waitlist Control (Other)

结局指标

主要结局

Sexual Behavior Involving Minors Scale (SBIMS).

时间窗: Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months

8 items; score range from 8 to 40; higher scores indicate more problem behavior.

Sexual Child Molestation Risk Assessment (SChiMRA) score

时间窗: Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months

6 items; scores involve marking an X on a slide rule from "very likely" to "not at all likely or nearly every day"; marks further to the right indicate higher risk.

次要结局

  • General Self-Efficacy Scale - Short Form (GSE-6).(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Depression, Anxiety and Stress Scale-21 (DASS-21)(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Suicidal Ideation Attributes Scale (SIDAS)(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Hypersexual Behavior Inventory-19 score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Sexual Attraction to Children(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Brief Aggression Questionnaire score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Short Self-Regulation Questionnaire score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Revised University of California, Los Angeles (UCLA) Loneliness Scale(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Self-Efficacy Scale Related to Minors (SESM)(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Emotional Congruence with Children score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Cognitions of internet sexual offending score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Cognitions that condone and support sexual offending against children scale - short form(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Alcohol Use Disorders Identification Test (AUDIT) score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)
  • Recent Alcohol & Cannabis Use score(Baseline, 1 month post waitlist (waitlist only), 1 month post-intervention, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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