Health Trials

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

ConditionPartner
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: PsychoeducationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment feasibility

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.

Time frame
12 months from study start
2

Recruitment and study procedures feasibility

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.

Time frame
4 months from enrollment
3

Study procedures feasibility

Study process log will assess number of completed sessions Criteria for success: \- At least 80% of participants complete a minimum of 3 sessions.

Time frame
Day 29 after treatment start (Post-intervention, session 5)

Secondary outcomes

1

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

Time frame
screening visit
2

psychiatric symptoms according to DSM-5 criteria

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

Time frame
screening visit
3

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.

Time frame
Day 15 (after session 2)
4

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

Time frame
Day 29 (Post-intervention, session 5)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
Apply now