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临床试验 NCT07434219 针对伴侣目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders. 20 创新疗法

尚未招募
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临床试验NCT07434219是一项针对伴侣干预性研究试验,当前状态为尚未招募试验尚未开始,计划于2026年3月31日开始,预计招募20名患者。该研究由Region Stockholm主导,计划于2029年3月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2026年2月25日
简要概括

The overall aim of this feasibility study is to investigate the clinical characteristics of female partners of male child sexual abuse material (CSAM) offenders and to evaluate the feasibility of a novel psychoeducational group intervention designed to address their specific needs.

The main questions it aims to answer are:

  1. What are the clinical characteristics of female partners of male CSAM offenders?
  2. Is a p...
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详细描述
Sexual offences against children online, including child sexual abuse material (CSAM), is a violation against human rights and is a growing public health problem all over the world. Relatives of CSAM offenders, inclusive partners, have shown to suffer a range of negative consequences. Several studies have identified a lack of adequate mental health support and emphasize the need for targeted interventions to help ind...显示更多
官方标题

A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders: A Non-Randomized Feasibility Study

疾病
伴侣
出版物
关于此临床试验发表的科学文章和研究论文:
其他研究标识符
  • 2025-07025-01
NCT编号
实际开始日期
2026-03-31
最近更新发布
2026-02-25
预计完成日期
2029-03-01
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
intervension
partner
pedophilia
主要目的
支持治疗
分配方式
不适用
干预模型
单组试验
盲法
无(开放性试验)
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Psychoeducation
The psychoeducational group intervention consists of a total of five sessions, each lasting approximately 90 minutes. The sessions are held weekly at the clinic or via video using a health care application and are facilitated by two experienced therapists. Each group will include approximately five participants.
A Group Based Psychoeducational Intervention
The purpose of the intervention is to increase the partners' ability to identify, understand, and manage the emotional, social, and practical stresses associated with being a partner of a CSAM offender; reduce the experience of isolation and shame through sharing experiences with people with similar experiences; and provide increased knowledge about sexual problems and treatment. Each session has a clear agenda with ...显示更多
主要终点
结果指标度量标准描述时间框架
Recruitment and study procedures feasibility
Study process log will assess recruitment pathway (patient/PrevenTell), number of screened individuals, number of individuals who decline, number of individuals excluded and on what grounds, time taken to recruit, time from recruitment to offered intervention, number of completed sessions and completed assessment forms. Criteria for success: * 15-20 participants recruited within 12 moths. * Recruited participants may be offered the group intervention within 4 months. * At least 80% of participants complete a minimum of 3 sessions.
Through study completion, which is anticipated to occur approximately 1 year and 9 months from the study start date.
Acceptability and relevance
Will be evaluated qualitatively through written anonymous open-ended questions after each visit.
After each session (Day 1, Day 8, Day 15, Day 22, Day 29)
Client Satisfaction Questionnaire (CSQ-8)
a scale for measuring of patient satisfaction with the service received. It consists of 8 questions and satisfaction is measured with a range of 8-32. Higher scores indicate greater satisfaction. Criteria for success: At least 80% of participants score 26 points or higher
Day 29 (Post-intervention, session 5)
Credibility/Expectancy Questionnaire (CEQ)
A scale for measuring treatment expectancy and rationale credibility to use in clinical outcome studies. Expectancy is measured with a range of 0-100% and credibility are measured with a range of 1-9. Higher scores indicate greater treatment credibility.
Day 15 (after session 2)
Negative Effects Questionnaire (NEQ)
The NEQ consists of 32 items assessing the occurrence of negative or unwanted effects associated with psychological treatment. For each item, participants first indicate whether the effect occurred (yes/no). If endorsed, participants rate how negatively the effect impacted them on a 5-point Likert scale ranging from 0 to 4 (0 = not at all, 4 = extremely). Severity ratings therefore range from 0 to 4 per item, with higher scores indicating greater negative impact. When severity ratings are summed across all 32 items, the total NEQ severity score ranges from 0 to 128, with higher total scores reflecting a greater number and/or severity of negative effects. In addition, participants indicate whether each negative effect is attributed primarily to the intervention or to other circumstances. NEQ data will be analyzed descriptively, including the number of endorsed negative effects, severity ratings, and attribution.
Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
次要终点
结果指标度量标准描述时间框架
Hospital Anxiety and depression scale (HADS)
a scale for detecting states of depression and anxiety first developed for the setting of an hospital medical outpatient clinic.. It consists of 14 questions where both depression and anxiety is measured with a range of 0-21. Score 7 or lower indicate no clinically significant anxiety or depression. Score 8-10 indicate gray area of depression or anxiety. Score 11 or more are likely indicating clinically significant depression or anxiety. Scores between 15 and 21 indicate severe anxiety or depression.
screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Posttraumatic Stress Disorder Checklist (version 5) (PCL-5)
revised from the original PCL, is a self-report measure developed to assess PTSD symptoms in accordance with the diagnostic criteria outlined in the DSM-V. It consists of 20 items to measure symptom severity, with options "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely," that correspond to scores of 1-5. A total symptom severity score (range - 0-80) can be obtained by summing the scores of all 20 items. It is suggested that cutoff score between 31-33 is indicative of probable PTSD across samples
screening visit
Mini-International Neuropsychiatric Interview 7.0 (M.I.N.I 7.0)
a brief, structured diagnostic interview developed collaboratively by psychiatrists and clinicians in the United States and Europe. It was designed to assess psychiatric disorders according to DSM-IV and ICD-10 criteria and created to provide a concise yet reliable diagnostic tool suitable for use in multicenter clinical trials and epidemiological studies, as well as a preliminary assessment instrument in non-research clinical settings
screening visit
The General Health Questionnaire 12 (GHQ -12)
measures self-rated general psychological health in the general population. It consists of 12 items, each item has four response options and is scored using the binary method (0, 0, 1, 1) with maximum score of 12. A high score indicates a potential risk of psychiatric problems. Individuals who score 3 or higher are defined as having reduced well-being.
screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
Work and Social Adjustment Scale (WSAS)
a brief, self-report measure designed to assess functional impairment attributable to an identified problem or mental health condition. It consists of five items evaluating the impact on work, home management, social leisure, private leisure, and close relationships. Each item is rated on a 9-point Likert scale ranging from 0 (no impairment) to 8 (very severe impairment), yielding a total score between 0 and 40.
screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
  • Female partners of male CSAM offenders
  • A score of ≥ 3 points on the General Health Questionnaire 12 (GHQ-12) at screening and an affirmative response to the follow-up question: Do you feel that your reduced psychological well-being is primarily related to your partner's CSAM offenses?
  • Ability to understand spoken and written Swedish
  • Willingness to participate in the intervention
  • Signed written informed consent form.

  • The partner has committed hands-on sexual offenses against children
  • Presence of a severe mental disorder (e.g., psychosis or major depression) requiring immediate treatment 8) Psychological or cognitive conditions that could compromise participant safety or study integrity (e.g., intellectual disability).
Region Stockholm logoRegion Stockholm
Karolinska Institutet logo卡罗琳学院
研究中心联系人
联系人: Ulrika Akerstedt, +46812373200, [email protected]
1 位于 1 个国家/地区的研究中心
ANOVA, Karolinska university hospital, Stockholm, Sweden
Josephine Savard, PhD, 联系人, +46812373200, [email protected]
Josephine Savard, PhD, 主要研究者