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Trial registered on ANZCTR


Registration number
ACTRN12624000862549
Ethics application status
Approved
Date submitted
20/06/2024
Date registered
12/07/2024
Date last updated
1/09/2024
Date data sharing statement initially provided
12/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Hybrid Effectiveness-Implementation Randomised Control Trial of the 'Left Write Hook' program for Adult Survivors of Child Sexual Abuse
Scientific title
A type II hybrid effectiveness-implementation randomised control trial evaluating the impact of Left Write Hook on general self-efficacy in adult survivors of child sexual abuse
Secondary ID [1] 312360 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex Posttraumatic Stress Disorder 334150 0
General Self-Efficacy 334157 0
Condition category
Condition code
Mental Health 330822 330822 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 330826 330826 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Left Write Hook intervention combines expressive writing and trauma-informed boxing. Left Write Hook is delivered via 8 x weekly 2-hour group-based sessions in a local sports centre or community room. Sessions are led by a Lead facilitator, and is assisted by an Assistant Facilitator, both of whom are survivors themselves Each session has two components; expressive writing and trauma-informed boxing. Peer-trainers guide participants to locate an empowered state, through stance, focus on punch, direction, and movement. Week 1 explains the program, introduces participants and establishes group safety. For Weeks 2-8, the first hour involves participants writing to prompts designed to reclaim their life narrative, with the option of sharing with the group. Prompts include ‘body’, ‘power’, ‘mind’, ‘healing is...’, ‘recovery’, ‘fighting back means...’ For the second hour, participants complete a trauma-informed group boxing session. This involves a warmup, technique session, drills, cool down and stretch. Each session ends with reflections. To monitor treatment adherence, session attendance will be recorded each week, Fidelity checklists which index all intervention components will also be completed by at the end of each intervention session by the Lead Facilitator, Assistant Facilitator and/or Boxing Coach, and two Participants (who will volunteer at the end of each session).

Facilitators for the trial are recruited from those currently delivering Left Write Hook in the community (outside of the trial context, with Left Write Hook being a pre-existing community program).

Past Left Write Hook participants, including those who have participated during the present trial, are invited to enrol in a 6-week, self-directed online training course to receive a certification in Trauma Informed Writing and Boxing Facilitation (also referred to as champion training). The training course involves six online modules that guide prospective champions through the essential components of facilitating a Left Write Hook program. Each module takes 3-4 hours to complete. Modules are comprised of a mix of multimedia resources, educational videos, group discussion boards, and assessments. Assessments include knowledge check-ins after each module, a digital portfolio to document skill development and learning (i.e. reflections on the benefits peer support, trauma-informed care, etc), a statement of practice as a trainer/coach, and a full day experiential class at the conclusion of the online training (approx 6 hours), where champions participate in a Left Write Hook session themselves then demonstrate practical skills learnt in the training (i.e. writing facilitation, warm ups, boxing combinations, etc). Training within the trial context is overseen by the research team. At the completion of the training program, collaborative discussion between the Head Trainer (an existing, experienced Left Write Hook facilitator) and trainee champions evaluates readiness to act as a Lead facilitator, or whether beginning as an Assistant Facilitator is preferable. Upon completion of the course, new facilitators can commence immediately and are shadowed by the Head Trainer for 1-2 sessions of their first Left Write Hook group. The Head Trainer supports confidence in delivering the intervention and provides personalised feedback on intervention delivery.
Intervention code [1] 328862 0
Treatment: Other
Comparator / control treatment
Participants randomised to control will complete 8 x weekly group sessions of trauma-informed, non-contact boxing, without writing, and without a specific focus on empowerment, to control for the positive effects of exercise on self-efficacy. Each week, participants will complete a 45-minute group boxing session, led by a boxing instructor (i.e., intervention is not peer-led) at the same sites as the intervention arm. Unlike the boxing component in the Left Write Hook intervention, the boxing-only control will have no specific empowerment focus during the boxing. The boxing training protocol will be based off the basic structure of the existing protocol for the Left Write Hook boxing component, with specific empowerment aspects removed. Specific exercises are at the discretion of the boxing instructor, and will be consistent across control groups. This replicates the type of trauma-informed exercise class that survivors could access in their local community.
Control group
Active

Outcomes
Primary outcome [1] 338590 0
General Self-Efficacy (effectiveness outcome)
Timepoint [1] 338590 0
Pre-intervention (0-weeks), Post-intervention (8-weeks - primary endpoint), One-month follow-up (12-weeks)
Primary outcome [2] 338591 0
Fidelity of the intervention (implementation outcome)
Timepoint [2] 338591 0
Post-intervention (8-weeks)
Secondary outcome [1] 436511 0
Complex Posttraumatic Stress Disorder (effectiveness outcome)
Timepoint [1] 436511 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [2] 436512 0
Trauma Memory Quality (effectiveness outcome)
Timepoint [2] 436512 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [3] 436514 0
Adoption - site (implementation outcome)
Timepoint [3] 436514 0
Continuous until end of trial
Secondary outcome [4] 436515 0
Depression (exploratory effectiveness outcome).
Timepoint [4] 436515 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [5] 436516 0
Loneliness (exploratory effectiveness outcome)
Timepoint [5] 436516 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [6] 436517 0
Social connectedness (exploratory effectiveness outcome)
Timepoint [6] 436517 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [7] 436518 0
Wellbeing (exploratory effectiveness outcome)
Timepoint [7] 436518 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [8] 436519 0
Health behaviours (exploratory effectiveness outcome). This will be assessed as a composite outcome.
Timepoint [8] 436519 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [9] 436805 0
Post-Traumatic Cognition (effectiveness outcome)
Timepoint [9] 436805 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [10] 436811 0
Sleep quality (exploratory effectiveness outcome)
Timepoint [10] 436811 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [11] 436812 0
Blood pressure (exploratory effectiveness outcome)
Timepoint [11] 436812 0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [12] 436813 0
Hand grip strength, as an indicator of upper body strength (effectiveness outcome)
Timepoint [12] 436813 0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
Secondary outcome [13] 436814 0
Flexibility (effectiveness outcome)
Timepoint [13] 436814 0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
Secondary outcome [14] 436815 0
Functional mobility (effectiveness outcome)
Timepoint [14] 436815 0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
Secondary outcome [15] 436816 0
Aerobic fitness (effectiveness outcome)
Timepoint [15] 436816 0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
Secondary outcome [16] 436817 0
Static balance (effectiveness outcome)
Timepoint [16] 436817 0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
Secondary outcome [17] 436818 0
Alcohol use (exploratory effectiveness outcome)
Timepoint [17] 436818 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [18] 436819 0
Smoking/vaping frequency (exploratory effectiveness outcome). This will be assessed as a composite outcome.
Timepoint [18] 436819 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [19] 436820 0
Access to health services (exploratory effectiveness outcome). This will be assessed as a composite outcome.
Timepoint [19] 436820 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [20] 436821 0
Adoption - provider (implementation outcome)
Timepoint [20] 436821 0
Continuous until end of trial
Secondary outcome [21] 437107 0
Quality of Life (exploratory effectiveness outcome)
Timepoint [21] 437107 0
Pre-intervention (0-weeks), post-intervention (8-weeks), one-month follow up (12-weeks).
Secondary outcome [22] 437108 0
Chronic Pain (exploratory effectiveness outcome)
Timepoint [22] 437108 0
Pre-intervention (0-weeks), post-intervention (8-weeks), one month follow-up (12-weeks)
Secondary outcome [23] 437109 0
Anxiety
Timepoint [23] 437109 0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
Secondary outcome [24] 437175 0
Arachidonoyl ethanolamide (exploratory effectiveness outcome)
Timepoint [24] 437175 0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [25] 437176 0
2-arachidonoyl glycerol (exploratory effectiveness outcome)
Timepoint [25] 437176 0
Pre-intervention (0-weeks), post-intervention (8-weeks)
Secondary outcome [26] 437177 0
Oleoylethanolamide (exploratory effectiveness outcome)
Timepoint [26] 437177 0
Pre-intervention (0-weeks), post-intervention (8-weeks)
Secondary outcome [27] 437179 0
Palmitoylethanolamide (exploratory effectiveness outcome)
Timepoint [27] 437179 0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [28] 437180 0
Stearoylethanolamide (exploratory effectiveness outcome)
Timepoint [28] 437180 0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [29] 437182 0
Lineoylethanolamide (exploratory effectiveness outcome)
Timepoint [29] 437182 0
Post-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [30] 437183 0
Arachidonic acid (exploratory effectiveness outcome)
Timepoint [30] 437183 0
Post-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [31] 437189 0
Cortisol (exploratory effectiveness outcome)
Timepoint [31] 437189 0
Post-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [32] 437190 0
Cortisone (exploratory effectiveness outcome)
Timepoint [32] 437190 0
Post-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [33] 437191 0
Dehydropiandrosterone (exploratory effectiveness outcome)
Timepoint [33] 437191 0
Post-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [34] 437192 0
Dehydropiandrosterone-sulfate (exploratory effectiveness outcome)
Timepoint [34] 437192 0
Post-intervention (0-weeks), Post-intervention (8-weeks)
Secondary outcome [35] 437193 0
Progesterone (exploratory effectiveness outcome)
Timepoint [35] 437193 0
Post-intervention (0-weeks), Post-intervention (8-weeks)

Eligibility
Key inclusion criteria
Age 18 years or older, female identifying or gender diverse, self-reported history of childhood sexual abuse or other gendered or family violence, letter indicating GP approval of participation and ongoing GP support to ensure that participants can safely participate. All levels of physical fitness are welcome.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
High levels of suicidality in need of more crisis management, evaluated by a clinical psychologist and informed by the Suicidal Ideation Attributes Scale (van Spijker et a., 2014)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation list will be generated at the start of the trial by an independent statistician and communicated to the trial manager after participant groups have been recruited into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation will use a block procedure for groups of 4-8 participants using computer-generated quasi-random numbers. Randomisation will be stratified by site, for between-site equity in number of groups in each arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed effects model

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2024
Actual
Date of last participant enrolment
Anticipated
30/01/2026
Actual
Date of last data collection
Anticipated
24/04/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316768 0
Government body
Name [1] 316768 0
Medical Research Future Fund (MRFF 2023, Consumer Led Research), Department of Health and Aged Care
Country [1] 316768 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318992 0
None
Name [1] 318992 0
Address [1] 318992 0
Country [1] 318992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315536 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315536 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 315536 0
Australia
Date submitted for ethics approval [1] 315536 0
24/01/2024
Approval date [1] 315536 0
08/03/2024
Ethics approval number [1] 315536 0

Summary
Brief summary
Adult survivors of child sexual abuse and other gendered violence are at heighten risk of both mental and physical health conditions. We seek to evaluate a peer-led program, Left Write Hook, which incorporates boxing and expressive writing, to empower survivors. This Type II Hybrid effectiveness-implementation randomised control trial aims to (1) evaluate effects of Left Write Hook in improving self-efficacy (primary effectiveness outcome), and subsequently, modifiable indicators for chronic disease (secondary effectiveness outcomes), in adult survivors of child sexual abuse and other gendered/family violence, and to (2) determine the fidelity of the train-the-champion implementation strategy for intervention training and delivery (primary implementation outcome). Compared to boxing-only, we expect Left Write Hook to meaningfully improve both mental and physical health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135002 0
Dr Caitlin Hitchcock
Address 135002 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 135002 0
Australia
Phone 135002 0
+61390353847
Fax 135002 0
Email 135002 0
[email protected]
Contact person for public queries
Name 135003 0
Caitlin Hitchcock
Address 135003 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 135003 0
Australia
Phone 135003 0
+61390353847
Fax 135003 0
Email 135003 0
[email protected]
Contact person for scientific queries
Name 135004 0
Caitlin Hitchcock
Address 135004 0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
Country 135004 0
Australia
Phone 135004 0
+61390353847
Fax 135004 0
Email 135004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Outcome measures
When will data be available (start and end dates)?
From the end of the trial, in perpetuity
Available to whom?
Open Science Framework (OSF) users
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Deidentified data will be stored on OSF
Until a data repository is available, Dr Caitlin Hitchcock ([email protected]) can be contacted regarding the IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23957Study protocol    387986-(Uploaded-04-07-2024-12-24-52)-Left Write Hook Protocol Version 3.docx



Results publications and other study-related documents

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