A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders: A Non-Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Recruitment and study procedures feasibility
研究概览
简要总结
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:
- What are the clinical characteristics of female partners of male CSAM offenders?
- Is a psychoeducational group intervention for female partners of male CSAM offenders feasible?
- Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?
Feasibility will be assessed in terms of 1) recruitment, time from recruitment to offered intervention and completed sessions 2) expectancy of treatment improvement, credibility, and satisfaction 3) acceptability and relevance 4) occurrence of negative effects 5) changes in depression- and anxiety symptoms and psychological well-being 6) changes in daily functioning.
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 individuals process and manage the psychological impact and challenges associated with being a relative to a CSAM offender.
The main questions it aims to answer are:
- What are the clinical characteristics of female partners of male CSAM offenders?
Guiding questions:
- Do individuals in this population meet criteria for any psychiatric diagnoses?
- What types of trauma-related symptoms are present within the population?
- What is the distribution of the degree of suicide risk (low, medium, high) within the population?
- Is a psychoeducational group intervention for female partners of male CSAM offenders feasible?
Guiding questions:
- To what extent is it feasible to recruit enough participants within a reasonable (12 months) timeframe?
- To what extent is it feasible to offer the group intervention within a reasonable (4 months) timeframe?
- To what extent do participants complete the intended number of sessions?
- How do participants perceive the treatment and are they satisfied with it?
- How do participants experience the intervention?
- Are there any negative effects associated with participation in the intervention?
- Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: A Group Based Psychoeducational Intervention (Behavioral)
结局指标
主要结局
Recruitment and study procedures feasibility
时间窗: Through study completion, which is anticipated to occur approximately 1 year and 9 months from the study start date.
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.
Acceptability and relevance
时间窗: After each session (Day 1, Day 8, Day 15, Day 22, Day 29)
Will be evaluated qualitatively through written anonymous open-ended questions after each visit.
Client Satisfaction Questionnaire (CSQ-8)
时间窗: Day 29 (Post-intervention, session 5)
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
Credibility/Expectancy Questionnaire (CEQ)
时间窗: Day 15 (after session 2)
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.
Negative Effects Questionnaire (NEQ)
时间窗: Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
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.
次要结局
- Hospital Anxiety and depression scale (HADS)(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)(screening visit)
- Mini-International Neuropsychiatric Interview 7.0 (M.I.N.I 7.0)(screening visit)
- The General Health Questionnaire 12 (GHQ -12)(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)(screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months))