Tertiary Prevention of Child Sexual Abuse

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06126926
Collaborator
(none)
32
2
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: group therapy
  • Other: Treatment as usual
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Factorial Assignment
Intervention Model Description:
Random assignment clinical trial. Participants are randomly assigned to the intervention group or treatment as usual.Random assignment clinical trial. Participants are randomly assigned to the intervention group or treatment as usual.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mobilizing Evidence Into Tertiary Prevention of Child Sexual Abuse: A Pilot Study
Anticipated Study Start Date :
Oct 30, 2023
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

32-week group therapy

Behavioral: group therapy
32 weeks of group therapy

Active Comparator: Control group

Treatment as Usual

Other: Treatment as usual
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.

Outcome Measures

Primary Outcome Measures

  1. Violence Risk Scale-Sexual Offense Version (VRS:SO) [7 days post-intervention]

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

  2. Coping Using Sex Inventory (CUSI) [7 days post-intervention]

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

  3. Compulsive Sexual Behavior Inventory-13 (CSBI-13) [7-days post-intervention]

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

  4. Types of Jealousy Scale (3 subscales; reactive, preventive, and anxious jealousy) [7 days post-intervention]

    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.

  5. Faith in People Scale [7 days post-intervention]

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

  6. Trust in People Scale (Survey Research Center) [7 days post-intervention]

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

  7. Aggression Questionnaire (AQ; Buss &amp) - Physical Aggression, Verbal Aggression, and Anger Subscales ONLY [7 days post-intervention]

    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.

  8. Revised UCLA Loneliness Scale (R-UCLA) [7 days post-intervention]

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

  9. Self-Critical Rumination Scale (SCRS) [7 days post-intervention]

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

  10. External/Internal Shame Scale - Sense of Isolation/Exclusion Subscale ONLY (EISS) [7 days post-intervention]

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

  11. Children and Sex Questionnaire Emotional Congruence Scale (CSQ:ECWC) [7 days post-intervention]

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

  12. The Openness to Men and Women Scales (OPM, OPWO) [7 days post-intervention]

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

  13. Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) [7 days post-intervention]

    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.

  14. Coping Strategy Indicator (CSI) [7 days post-intervention]

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

  15. Aggression Inventory (AI)- Impulsive, Impatient, and Avoid subscales ONLY [7 days post-intervention]

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

Secondary Outcome Measures

  1. Group Climate Questionnaire - Short Form (GCQ-5) [Every 14 days for first two months, than every four weeks for next four months]

    Self-report scale. 12 items measuring group perceptions of the group therapeutic environment on a 7 point scale.

  2. Curative Climate Instrument (CCI) [Every 14 days for first two months, than every four weeks for next four months]

    Self-report scale. 14 items measuring specific change processes perceived as helpful to individual group members (catharsis, insight, and cohesiveness) on a 5 point scale.

  3. Treatment Motivation Questionnaire-Revised (TMQ-R) [Every 14 days for first two months, than every four weeks for next four months]

    Self-report scale. 23 items measuring internal and external reasons for participating in treatment, motivations relating to connecting and sharing with others, and clients' potential lack of confidence in treatment on a 7 point scale.

  4. Therapeutic Agency Inventory (TAI) [Every 14 days for first two months, than every four weeks for next four months]

    Self-report scale. 15 items measuring clients' experience of agency in making positive change and ability to take an active role in their therapy on a 5 point scale.

  5. Relationship Questionnaire (RQ) [Every 14 days for first two months, than every four weeks for next four months]

    Self-report scale. 4 items measuring adult attachment style on a 7 point scale.

  6. Working Alliance Inventory - Short Form (WAI- SR) [Every 14 days for first two months, than every four weeks for next four months]

    Self-report scale. 12 items measuring three domains of the therapeutic alliance: goals, tasks, and bond on a 5 point scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male

  • 18 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."

Exclusion Criteria:
  • 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"

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Michael Miner, Ph.D, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT06126926
Other Study ID Numbers:
  • FMCH-2023-32331
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 13, 2023