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임상시험 NCT07434219은(는) 파트너에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders. 20 신규 요법
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07434219은(는) 파트너에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 3월 31일부터 참여 신청이 가능합니다. 20명의 참여자를 모집할 예정입니다. Region Stockholm이(가) 진행하는 이 연구는 2029년 3월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 25일에 갱신되었습니다.
간단한 개요
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 p...
상세한 설명
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...더 보기
공식 제목
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders: A Non-Randomized Feasibility Study
질환명
파트너출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- 2025-07025-01
NCT 번호
실제 연구 시작일
2026-03-31
최신 업데이트 게시
2026-02-25
예상 연구 완료일
2029-03-01
계획된 등록 인원
20
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
intervension
partner
pedophilia
partner
pedophilia
주요 목적
지지요법
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Psychoeducation 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 ...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
여성
- 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).
연구 대표 연락처
연락처: Ulrika Akerstedt, +46812373200, [email protected]
1 1개국에 임상시험 장소
ANOVA, Karolinska university hospital, Stockholm, Sweden
Josephine Savard, PhD, 연락처, +46812373200, [email protected]
Josephine Savard, PhD, 책임연구자