- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434219
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders: A Non-Randomized Feasibility Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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?
Guiding questions:
- Are there any changes in depression- and anxiety symptoms and psychological well-being?
- Are there any changes in daily functioning?
The study will be conducted at ANOVA, Karolinska University Hospital, Sweden. ANOVA is a multidisciplinary clinic and research unit within sexual medicine, andrology and trans medicine. The clinic has many years of clinical experience in assessment, treatment, and research of pedophilia and other sexual medicine conditions. ANOVA operates PrevenTell, a national helpline and chat service for unwanted sexuality, which is the primary means of reaching the target group.
Potentially eligible participants will be invited to ANOVA at Karolinska University Hospital for an on-site assessment with the research team, including a psychiatrist. During this visit, participants will receive verbal information about the study, written participant information will be provided, and informed consent will be obtained. Participants will then complete questionnaires and other study measurements.
The psychoeducational group intervention will include female partners (n=20), and consists of a total of five sessions, each lasting approximately 90 minutes. To clarify the outcome time frame, the first session is considered Day 1. The sessions are held weekly. The group manual is based on our clinical experience of working with relatives, previous research from other countries, and the results of a qualitative study carried out at ANOVA, Karolinska University Hospital (Adebahr et al, 2025.).
The purpose of the intervention is to increase partners' ability to identify, understand, and manage the emotional, social, and practical stresses associated with being a partner of a CSAM offender; to reduce experiences of isolation and shame through the sharing of experiences with others in similar situations; and to provide increased knowledge about sexual problems and available treatments.
An individual follow-up visit with a therapist will take place at the clinic or via video once the group sessions have been completed.
Data analysis Demographic and clinical characteristics of the participants will be presented descriptively. Quantitative data will be analyzed using descriptive statistics, including the calculation of means and standard deviations or interquartile ranges. Pre- and post- intervention assessments will be conducted to examine changes in secondary outcome measures, providing insight into potential effects of the intervention.
Qualitative data will be analyzed using qualitative content analysis with a descriptive manifest approach.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ulrika Akerstedt
- Phone Number: +46812373200
- Email: ulrika.akerstedt@ki.se
Study Locations
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-
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Stockholm, Sweden
- ANOVA, Karolinska university hospital
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Contact:
- Josephine Savard, PhD
- Phone Number: +46812373200
- Email: josephine.savard@regionstockholm.se
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Principal Investigator:
- Josephine Savard, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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 a defined theme and includes opportunities for reflection and the sharing of experiences.
The session themes are: 1) Crisis and emotional impact, 2) Emotional responses over time, 3) Relationships and social impact, 4) Practical impact and sexual issues, 5) Summary and future perspectives.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment feasibility
Time Frame: 12 months from study start
|
Study process log will assess recruitment pathway (number of screened individuals, number of individuals who decline, number of individuals excluded and on what grounds) Criteria for success: - 15-20 participants recruited within 12 moths. |
12 months from study start
|
|
Recruitment and study procedures feasibility
Time Frame: 4 months from enrollment
|
Study process log will assess time taken to recruit and time from recruitment to offered intervention Criteria for success: Recruited participants may be offered the group intervention within 4 months. |
4 months from enrollment
|
|
Study procedures feasibility
Time Frame: Day 29 after treatment start (Post-intervention, session 5)
|
Study process log will assess number of completed sessions Criteria for success: - At least 80% of participants complete a minimum of 3 sessions. |
Day 29 after treatment start (Post-intervention, session 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability and relevance
Time Frame: After each session (Day 1, Day 8, Day 15, Day 22, Day 29)
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Will be evaluated qualitatively through written anonymous open-ended questions after each visit.
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After each session (Day 1, Day 8, Day 15, Day 22, Day 29)
|
|
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 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 |
Day 29 (Post-intervention, session 5)
|
|
Credibility/Expectancy Questionnaire (CEQ)
Time Frame: Day 15 (after session 2)
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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)
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|
Negative Effects Questionnaire (NEQ)
Time Frame: 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. |
Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
|
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Posttraumatic Stress Disorder Checklist (version 5) (PCL-5)
Time Frame: screening visit
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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
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screening visit
|
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The General Health Questionnaire 12 (GHQ -12)
Time Frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
|
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.
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screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
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|
Work and Social Adjustment Scale (WSAS)
Time Frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
|
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.
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screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
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psychiatric symptoms according to DSM-5 criteria
Time Frame: screening visit
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a structured evaluation of psychiatric symptoms according to DSM-5 criteria.
The interview is conducted by a psychiatrist.
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screening visit
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The Montgomery-Åsberg Depression Rating Scale - Self rating (MADRS-S)
Time Frame: screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
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Score range is 0-54.
A higher score indicates more severe problems
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screening visit, Day 29 (Post-intervention, session 5), and 3 months after session 5 (i.e., Day 29 + 3 months)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-07025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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