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NCT Number: NCT07434219

A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.

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 psychoeducational group intervention for female partners of male CSAM offenders feasible? 3. 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.

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Key information

Conditions

Partner Mental Disorders Paraphilic Disorders Pedophilia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ANOVA, Karolinska university hospital

Stockholm, Sweden

Location contact

Josephine Savard, PhD

CONTACT

[email protected]

+46812373200

Josephine Savard, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

A Group Based Psychoeducational Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Posttraumatic Stress Disorder Checklist (version 5) (PCL-5)

    Time frame: screening visit

    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

  2. psychiatric symptoms according to DSM-5 criteria

    Time frame: screening visit

    a structured evaluation of psychiatric symptoms according to DSM-5 criteria. The interview is conducted by a psychiatrist.

  3. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: 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.

  4. 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

  5. Acceptability and relevance

    Time frame: 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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)

    Score range is 0-54. A higher score indicates more severe problems

Study contacts

Contact information is provided by the study sponsor or research team.

Ulrika Akerstedt

CONTACT

[email protected]

+46812373200

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Feb 25, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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