NCT07434219

Brief Summary

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. 1.What are the clinical characteristics of female partners of male CSAM offenders?
  2. 2.Is a psychoeducational group intervention for female partners of male CSAM offenders feasible?
  3. 3.Does a psychoeducational group intervention for female partners of male CSAM offenders provide any indication of effectiveness?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

February 9, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

intervensionpartnerpedophilia

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 months from study start

  • 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.

    4 months from enrollment

  • 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.

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

Secondary Outcomes (9)

  • Posttraumatic Stress Disorder Checklist (version 5) (PCL-5)

    screening visit

  • psychiatric symptoms according to DSM-5 criteria

    screening visit

  • Credibility/Expectancy Questionnaire (CEQ)

    Day 15 (after session 2)

  • Client Satisfaction Questionnaire (CSQ-8)

    Day 29 (Post-intervention, session 5)

  • Acceptability and relevance

    After each session (Day 1, Day 8, Day 15, Day 22, Day 29)

  • +4 more secondary outcomes

Study Arms (1)

Psychoeducation

EXPERIMENTAL

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.

Behavioral: A Group Based Psychoeducational Intervention

Interventions

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.

Psychoeducation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ANOVA, Karolinska university hospital

Stockholm, Sweden

Location

Related Publications (1)

  • Adebahr R, Savard J, Akerstedt U, Bystrom M, Sparre C, Hadding C, Gorts Oberg K, Jokinen J. Healthcare needs and barriers to care among female partners of male suspects of child sexual abuse material offences in Sweden: a qualitative interview study. Front Psychiatry. 2025 Oct 22;16:1618162. doi: 10.3389/fpsyt.2025.1618162. eCollection 2025.

    PMID: 41200223BACKGROUND

MeSH Terms

Conditions

Pedophilia

Condition Hierarchy (Ancestors)

Paraphilic DisordersMental Disorders

Central Study Contacts

Ulrika Akerstedt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 25, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Pseudonymized personal data may be shared with researchers both within and outside the EU/EEA, provided that the research proposals are methodologically sound. Relevant data-sharing agreements will be established in accordance with applicable legislation.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
10 years after completion of the study.
Access Criteria
A written proposal describing the planned analyses must be submitted to josephine.savard@regionstockholm.se, and a data-sharing agreement must be signed prior to any data transfer

Locations