NCT06126926

Brief Summary

This is a feasibility study designed to inform the development of a multinational study of the effectiveness of a tertiary prevention program for child sexual abuse. This study targets adult men who have engaged in child sexual abuse, and will be implemented within the Minnesota Department of Corrections. Data will include measures of the implementation process, short-terms changes in criminogenic factors, and staff and participant factors that could influence outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

October 16, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

October 16, 2023

Last Update Submit

January 5, 2026

Conditions

Outcome Measures

Primary Outcomes (15)

  • Violence Risk Scale-Sexual Offense Version (VRS:SO)

    Clinician rating scale. 24-items measuring likelihood of sexual offense recidivism using a 4 point scale.

    7 days post-intervention

  • Coping Using Sex Inventory (CUSI)

    Self-report scale. 16 items measuring consensual, non-consensual, and child-focused sexual coping strategies using a 5-point scale

    7 days post-intervention

  • Compulsive Sexual Behavior Inventory-13 (CSBI-13)

    Self-report scale. 13 item scale measuring the presence of compulsive sexual behaviors on a 5- point scale.

    7-days post-intervention

  • Types of Jealousy Scale (3 subscales; reactive, preventive, and anxious jealousy)

    Self-report scale. 15 items measuring the intensity of reactive jealousy, experience and use of preventive jealousy, and frequency of anxious jealousy on a 5-point scale.

    7 days post-intervention

  • Faith in People Scale

    Self-report scale. 5 item scale measuring attitudes toward human nature. Two forced- choice items and three agreement/disagreement items.

    7 days post-intervention

  • Trust in People Scale (Survey Research Center)

    Self-report scale. 3 item scale measuring perception of general trustworthiness of others.

    7 days post-intervention

  • Aggression Questionnaire (AQ; Buss &amp) - Physical Aggression, Verbal Aggression, and Anger Subscales ONLY

    Self-report scale. 21 items throughout the 3 subscales measuring how characteristic physical aggression, verbal aggression, and anger-related behaviors are for respondents on a 7 point scale.

    7 days post-intervention

  • Revised UCLA Loneliness Scale (R-UCLA)

    Self-report scale. 20 items measuring subjective feelings of loneliness and social isolation on a 4 point scale.

    7 days post-intervention

  • Self-Critical Rumination Scale (SCRS)

    Self-report scale. 10 items measuring self- criticism on a 4 point scale.

    7 days post-intervention

  • External/Internal Shame Scale - Sense of Isolation/Exclusion Subscale ONLY (EISS)

    Self-report scale. Measures perceived sense of exclusion and being isolated or misunderstood by people on a 5 point scale.

    7 days post-intervention

  • Children and Sex Questionnaire Emotional Congruence Scale (CSQ:ECWC)

    Self-report scale. 15 item scale measuring emotional congruence with children on a 5 point scale.

    7 days post-intervention

  • The Openness to Men and Women Scales (OPM, OPWO)

    Self-report scale. 18 items assessing openness to intimacy with women and men on a 4 point scale.

    7 days post-intervention

  • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

    Self-report scale. 18 items measuring problems with emotion regulation including subscales for strategies, non-acceptance, impulse, goals, awareness, and clarity on a 5 point scale.

    7 days post-intervention

  • Coping Strategy Indicator (CSI)

    Self-report scale. 33 items measuring adaptive and maladaptive coping strategies (avoidance, problem-solving, social support seeking) on a 3 point scale.

    7 days post-intervention

  • Aggression Inventory (AI)- Impulsive, Impatient, and Avoid subscales ONLY

    Self-report scale. 22 item scale measuring perceptions and use of aggressive behaviors for men a women on a 5 point scale.

    7 days post-intervention

Secondary Outcomes (6)

  • Group Climate Questionnaire - Short Form (GCQ-5)

    Every 14 days for first two months, than every four weeks for next four months

  • Curative Climate Instrument (CCI)

    Every 14 days for first two months, than every four weeks for next four months

  • Treatment Motivation Questionnaire-Revised (TMQ-R)

    Every 14 days for first two months, than every four weeks for next four months

  • Therapeutic Agency Inventory (TAI)

    Every 14 days for first two months, than every four weeks for next four months

  • Relationship Questionnaire (RQ)

    Every 14 days for first two months, than every four weeks for next four months

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

32-week group therapy

Behavioral: group therapy

Control group

ACTIVE COMPARATOR

Treatment as Usual

Other: Treatment as usual

Interventions

group therapyBEHAVIORAL

32 weeks of group therapy

Intervention arm

Control participants remain in their current placement and may be eligible for a number of services offered to inmates to facilitate rehabilitation and planning for release to the community, including sexual offender treatment. MnDOC's sexual offender treatment is a two to three year program, thus most of our control subjects will not have enough time remaining on their sentences to complete such treatment. However, a number of them may participate in MnDOC's current program.

Control group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsYes, the current study includes only men, as the intervention is designed for men who have perpetrated child sexual abuse.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • or older
  • Serving time in MnDOC facilities for Criminal Sexual Conduct in the first, second, or third degree, whose victims were less than 14 years old
  • Individuals assigned moderate to high risk to reoffend as determined upon entrance to the Minnesota Correctional System by the DOC Risk Assessment/Community Notification Unit."

You may not qualify if:

  • Diagnosed with an active, uncontrolled major mental disorder (e.g. bi-polar, schizophrenia, schizoaffective disorder, major depression with psychotic features)
  • Unable to read English at the 5th grade level
  • Unable to speak English
  • IQ of less than 85 as measured by standard intelligence tests
  • Diagnosis of intellectual disability
  • Engaged in violent behavior while incarcerated, as indicated by disciplinary actions and/or segregation within 60 days of intake"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Interventions

Psychotherapy, GroupTherapeutics

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Miner, Ph.D

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Random assignment clinical trial. Participants are randomly assigned to the intervention group or treatment as usual.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

November 13, 2023

Study Start

May 31, 2024

Primary Completion

May 14, 2025

Study Completion

December 31, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations