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Trial registered on ANZCTR


Registration number
ACTRN12622000666729
Ethics application status
Approved
Date submitted
13/04/2022
Date registered
6/05/2022
Date last updated
31/05/2024
Date data sharing statement initially provided
6/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Stand Strong, Walk Tall - Pilot of a prehabilitation programme with the dual aims of improving psychological wellbeing for individuals who experience sexual interest in children, and preventing child sexual abuse
Scientific title
Stand Strong, Walk Tall: Prehabilitation for a Better Future - A Sexual Abuse Prevention Project - Phase Two: Pilot Delivery and Evaluation
Secondary ID [1] 306708 0
None
Universal Trial Number (UTN)
U1111-1266-8711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pedophilic interest 325973 0
Child sexual abuse 326131 0
Condition category
Condition code
Mental Health 323288 323288 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Stand Strong, Walk Tall (SSWT)
Intervention objectives: These are twofold and include both improved psychological wellbeing for individuals who experience sexual interest in children; and prevention of child sexual abuse.
Materials: https://ir.canterbury.ac.nz/handle/10092/100828. SSWT is a psychotherapeutic intervention. Project clinicians are guided by an intervention framework document, Clinician's Guide, three-day training, and regular project-focused clinical and cultural supervision, in addition to their pre-existing relevant psychological knowledge and expertise in psychotherapeutic processes.
Procedures: Study participants will be individuals meeting inclusion criteria who learn of the study, choose to self-refer, and provide informed consent. Participants will engage in an initial psychological assessment (including anticipated 2-3 hours of clinical interviews and 2-3 psychometric testing sessions), an individualised case formulation-informed psychotherapeutic intervention (encompassing a number of 60-minute cognitive-behavioural therapy sessions with key targets/content including: strengthen general and sexual self-regulation, emotion management, and coping with stress; build self-efficacy; address maladaptive thoughts/schema surrounding child sexual abuse; explore stigma and strategies to navigate stigma; strengthen skills for adult intimate relationships; good life planning), and re-assessment immediately post-intervention (1-2 testing sessions).
Intervention providers: New Zealand registered psychologists with expertise and experience in the relevant field. A three-day training event specific to SSWT delivery is provided (by the SSWT research team members, remotely via videoconference across a three-day period, in the month prior to trial commencement) to all project clinicians who are external to the research team, along with monthly clinical and cultural supervision, as noted above.
Mode of delivery: Individually, in person or via secure audio/visual connection.
Intervention location: University-based clinical psychology clinics; service sites of participating community-based harmful sexual behaviour (HSB) agencies, and/or secure virtual setting.
Intervention timing/amount: Varying according to individual need. Using best practice recommendations published by National Institute for Health and Care Excellence (NICE) as a guide, we expect intervention duration could range between approximately 6-10 therapy sessions of 8-12 weeks for someone with few intervention needs; at least 16-20 sessions over 3-4 months in the context of diagnosable mental health problems; more sessions may be required in the context of mental health problems coupled with sexual self-regulation difficulties. The maximum duration that intervention sessions will be delivered within the pilot is 12 months post-enrolment.
Tailoring: Intervention will be personalised based on the range and level of treatment needs identified during the pre-intervention assessment and individualised case formulation, and planned collaboratively with the individual.
Modifications: The intention is to refine the Clinician's Guide across the course of the pilot, in preparation for any future broader roll-out or future clinical use.
Fidelity: Fidelity-enhancing strategies include provision of 3-day clinician training, and regular group clinical and cultural supervision with members of the SSWT research team for all pilot clinicians. A purpose-designed checklist will also be employed to monitor fidelity to the SSWT clinician training including the intervention framework and philosophy.
Intervention code [1] 323333 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331048 0
Change on identified treatment targets relevant to sexual offence risk, as measured by ratings on a modified version of the Violence Risk Scale-Sexual Offense Version (VRS-SO) dynamic scale (modified for applicability to the minor-attraction prehabilitation setting in collaboration with other researchers).
Timepoint [1] 331048 0
Pre-intervention assessment (baseline), and post-intervention assessment (primary timepoint). The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Primary outcome [2] 331049 0
Change on identified treatment targets relevant to protective factors against sexual offending, as measured by ratings on the Structured Assessment of PROtective Factors for Violence Risk - Sexual Offence Version (SAPROF-SO).
Timepoint [2] 331049 0
Pre-intervention assessment (baseline), and post-intervention assessment (primary timepoint). The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Primary outcome [3] 331050 0
Changes in general wellbeing, measured across Seligman's five pillars of wellbeing (Positive emotions, Engagement, Relationships, Meaning, and Accomplishment) using the PERMA-Profiler.
Timepoint [3] 331050 0
Pre-intervention assessment (baseline), and post-intervention assessment (primary timepoint). The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [1] 408585 0
Change in level of self-acceptance, measured by a modified version of the Self-Stigma Mental Illness Scale (SSMIS; modified specifically for this study to pertain to minor-attraction related self-stigma).
Timepoint [1] 408585 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [2] 408586 0
Change in level of offence-supportive beliefs relevant to sexual contact between adults and children, measured by the MOLEST scale.
Timepoint [2] 408586 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [3] 408587 0
Change in level of general self-efficacy, measured by the 'General' sub-scale of the Self-Efficacy Scale (SES - General).
Timepoint [3] 408587 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [4] 408588 0
Change in level of self-efficacy specific to managing sexual urges towards minors, measured by the Self-Efficacy Scale Related to Minors (SESM).
Timepoint [4] 408588 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [5] 408589 0
Change in level of self-regulation ability, measured by the Short Self-Regulation Questionnaire (SSRQ).
Timepoint [5] 408589 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [6] 408590 0
Change in level of difficulties with emotion regulation, measured by the Difficulties in Emotion Regulation Scale Short Form (DERS-SF).
Timepoint [6] 408590 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [7] 408591 0
Change in coping styles in response to stressful situations, measured by the Coping Inventory for Stressful Situations - Short Form (CIFF-SF).
Timepoint [7] 408591 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [8] 408592 0
Change in experiences of loneliness and feelings of belonging, measured by the UCLA Loneliness Scale.
Timepoint [8] 408592 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [9] 408593 0
Change in level of anxiety regarding intimate adult relationships, measured by the Fear of Intimacy Scale (FIS).
Timepoint [9] 408593 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [10] 408661 0
Change in relative levels of sexual interest in children and adults, measured by the Sexual Fantasy Go/No-Go Association Task (SF-GNAT).
Timepoint [10] 408661 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [11] 408662 0
Change in level of readiness to change, measured by the University of Rhode Island Change Assessment Scale (URICA).
Timepoint [11] 408662 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [12] 408663 0
Change in levels of psychological distress, measured by the Depression, Anxiety and Stress Scale-21 (DASS-21).

Timepoint [12] 408663 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [13] 408664 0
Change in levels of problematic alcohol use, measured by the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [13] 408664 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [14] 408665 0
Change in levels of problematic drug use (excluding alcohol and tobacco), measured by the Drug Abuse Screening Test (DAST).
Timepoint [14] 408665 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [15] 408666 0
Change in individual, interpersonal, social, and general domains of wellbeing, measured by the Outcome Rating Scale (ORS) of the Partners for Change Management System (PCOMS).
Timepoint [15] 408666 0
At each therapy session.
Secondary outcome [16] 408667 0
Change in the quality of the therapeutic alliance, measured by the Session Rating Scale (SRS) of the Partners for Change Management System (PCOMS).
Timepoint [16] 408667 0
At each therapy session.
Secondary outcome [17] 408668 0
Level of attainment of treatment goals, rated according to a standardised version of Goal Attainment Scaling (GAS) developed specifically for this study.
Timepoint [17] 408668 0
Post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [18] 408669 0
Change in confidence in attaining valued Primary Human Goods, measured clinically using a 1-10 rating scale.
Timepoint [18] 408669 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [19] 408671 0
Change in frequency of harmful sexual behaviours, measured using a modified version of the Sexual Experiences Scale Short Form Perpetration (SES-SFP; modified by the research team for this study and others, to increase relevance to behaviours involving minors).
Timepoint [19] 408671 0
Pre-intervention assessment (baseline), and post-intervention assessment. The post-intervention assessment timepoint will occur at an individually-determined endpoint for each participant (following the participant's completion of the intervention phase).
Secondary outcome [20] 408672 0
Change in frequency of harmful sexual behaviours, measured by follow-up of officially recorded criminal offence information.
Timepoint [20] 408672 0
Pre-intervention assessment (baseline), and post-intervention follow-up periods of 2, 5, and 10 years.

Eligibility
Key inclusion criteria
- Individuals residing in the community in New Zealand
- Aged 18 years or older
- Experience sexual interest in children (i.e., aged under 16 in line with New Zealand law); and
- Self-refer to the pilot
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Individuals with cognitive functioning in the very low range
- Individuals who self-refer but upon assessment are found to not meet inclusion criterion regarding sexual interest in children - e.g., those whose thoughts about children occur exclusively in the context of an obsessive-compulsive disorder, those who experience concerning sexual ideation not involving minors, etc.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective longitudinal design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim for a minimum of 20 participants across the pilot. Anticipated sample size was determined based on clinical considerations. A sample of N=20 will yield 80% power to detect within-subject changes equivalent to d = .66 (moderate effect) at the p < .05 level. Clinically significant and reliable change thresholds will also be calculated to assess the significance of individual change for each case.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2022
Actual
20/06/2022
Date of last participant enrolment
Anticipated
31/05/2023
Actual
31/05/2023
Date of last data collection
Anticipated
30/09/2033
Actual
14/10/2023
Sample size
Target
20
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 24727 0
New Zealand
State/province [1] 24727 0

Funding & Sponsors
Funding source category [1] 311037 0
Government body
Name [1] 311037 0
Ministry of Social Development
Country [1] 311037 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Private Bag 4800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 312596 0
None
Name [1] 312596 0
Address [1] 312596 0
Country [1] 312596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310585 0
Health and Disability Ethics Committee (Northern B)
Ethics committee address [1] 310585 0
Ethics committee country [1] 310585 0
New Zealand
Date submitted for ethics approval [1] 310585 0
05/01/2022
Approval date [1] 310585 0
27/04/2022
Ethics approval number [1] 310585 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118170 0
Dr Sarah Christofferson
Address 118170 0
School of Psychology, Speech and Hearing
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 118170 0
New Zealand
Phone 118170 0
+64 3 369 4353
Fax 118170 0
Email 118170 0
sarah.christofferson@canterbury.ac.nz
Contact person for public queries
Name 118171 0
Sarah Christofferson
Address 118171 0
School of Psychology, Speech and Hearing
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 118171 0
New Zealand
Phone 118171 0
+64 3 369 4353
Fax 118171 0
Email 118171 0
sarah.christofferson@canterbury.ac.nz
Contact person for scientific queries
Name 118172 0
Sarah Christofferson
Address 118172 0
School of Psychology, Speech and Hearing
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 118172 0
New Zealand
Phone 118172 0
+64 3 369 4353
Fax 118172 0
Email 118172 0
sarah.christofferson@canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any de-identified individual participant data underlying published results.
When will data be available (start and end dates)?
Commencing immediately following publication and ending 10 years following.
Available to whom?
Researchers who provide a methodologically sound proposal, determined on a case by case basis at the discretion of Primary Sponsor and Principal Investigator. In all cases, the Principal Investigator must be satisfied that appropriate Data Management Plans are in place and that ethical approval for use has been obtained in accordance with local laws and regulations.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (sarah.christofferson@canterbury.ac.nz).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15779Study protocol  sarah.christofferson@canterbury.ac.nz
15780Informed consent form  sarah.christofferson@canterbury.ac.nz
15781Ethical approval  sarah.christofferson@canterbury.ac.nz
15783Other  sarah.christofferson@canterbury.ac.nz Data Management Plan



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.