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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
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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
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Secondary ID [1]
312360
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Complex Posttraumatic Stress Disorder
334150
0
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General Self-Efficacy
334157
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Condition category
Condition code
Mental Health
330822
330822
0
0
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Other mental health disorders
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Physical Medicine / Rehabilitation
330826
330826
0
0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328862
0
Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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General Self-Efficacy (effectiveness outcome)
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Assessment method [1]
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General Self-Efficacy Scale
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Timepoint [1]
338590
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Pre-intervention (0-weeks), Post-intervention (8-weeks - primary endpoint), One-month follow-up (12-weeks)
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Primary outcome [2]
338591
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Fidelity of the intervention (implementation outcome)
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Assessment method [2]
338591
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Fidelity checklists assessing core intervention components (i.e. writing to prompts, sharing writing to group, warm up, boxing exercises, reflections). These checklists are study specfic, created by the research team.
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Timepoint [2]
338591
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Post-intervention (8-weeks)
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Secondary outcome [1]
436511
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Complex Posttraumatic Stress Disorder (effectiveness outcome)
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Assessment method [1]
436511
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International Trauma Questionnaire
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Timepoint [1]
436511
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [2]
436512
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Trauma Memory Quality (effectiveness outcome)
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Assessment method [2]
436512
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Trauma Memory Quality Questionnaire
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Timepoint [2]
436512
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [3]
436514
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Adoption - site (implementation outcome)
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Assessment method [3]
436514
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The research team will track number of sites approached, taking part and withdrawals including reasons why. Characteristics of sites will be tracked by the research team via site audits/implementation checks and semi-structured interviews with site-leads. Interviews will be conducted with a member of the research team, will be approximately 30-minutes, and will be audio-recorded.
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Timepoint [3]
436514
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Continuous until end of trial
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Secondary outcome [4]
436515
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Depression (exploratory effectiveness outcome).
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Assessment method [4]
436515
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Depression, Stress, Anxiety Scale -21
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Timepoint [4]
436515
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [5]
436516
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Loneliness (exploratory effectiveness outcome)
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Assessment method [5]
436516
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UCLA 3-item Loneliness Scale
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Timepoint [5]
436516
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [6]
436517
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Social connectedness (exploratory effectiveness outcome)
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Assessment method [6]
436517
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Social connectedness scale
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Timepoint [6]
436517
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [7]
436518
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Wellbeing (exploratory effectiveness outcome)
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Assessment method [7]
436518
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Short Warwick Edinburgh Mental Wellbeing Scale
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Timepoint [7]
436518
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [8]
436519
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Health behaviours (exploratory effectiveness outcome). This will be assessed as a composite outcome.
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Assessment method [8]
436519
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24-hour movement behaviour (sleep, sedentary time, moderate-to-vigorous intensity activity, other movement, standing: must sum to 24 hours) on a typical day in the past week. We will also ask how many days in the last week participants performed muscle strengthening exercises, such as bodyweight exercises or resistance training, and how many days participants did moderate- to vigorous-intensity activity.
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Timepoint [8]
436519
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [9]
436805
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Post-Traumatic Cognition (effectiveness outcome)
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Assessment method [9]
436805
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Post-Traumatic Cognitions Inventory
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Timepoint [9]
436805
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [10]
436811
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Sleep quality (exploratory effectiveness outcome)
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Assessment method [10]
436811
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Insomnia Severity Index
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Timepoint [10]
436811
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Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [11]
436812
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Blood pressure (exploratory effectiveness outcome)
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Assessment method [11]
436812
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Automated blood pressure cuff
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Timepoint [11]
436812
0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [12]
436813
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Hand grip strength, as an indicator of upper body strength (effectiveness outcome)
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Assessment method [12]
436813
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Digital hand dynamometer
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Timepoint [12]
436813
0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
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Secondary outcome [13]
436814
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Flexibility (effectiveness outcome)
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Assessment method [13]
436814
0
Sit and reach kit
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Timepoint [13]
436814
0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
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Secondary outcome [14]
436815
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Functional mobility (effectiveness outcome)
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Assessment method [14]
436815
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30 second sit-to-stand test, indexing how many times a person can stand up from sitting on a chair without using their hands in a 30 second period
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Timepoint [14]
436815
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Pre-intervention (0-weeks); Post-intervention (8-weeks)
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Secondary outcome [15]
436816
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Aerobic fitness (effectiveness outcome)
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Assessment method [15]
436816
0
3-minute step test, measuring how quickly a person’s heart rate recovers after exercise
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Timepoint [15]
436816
0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
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Secondary outcome [16]
436817
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Static balance (effectiveness outcome)
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Assessment method [16]
436817
0
4-step balance test, indexing a person’s ability to stand in four positions for 10 seconds at a time.
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Timepoint [16]
436817
0
Pre-intervention (0-weeks); Post-intervention (8-weeks)
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Secondary outcome [17]
436818
0
Alcohol use (exploratory effectiveness outcome)
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Assessment method [17]
436818
0
Alcohol Use Disorders Identification Test
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Timepoint [17]
436818
0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [18]
436819
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Smoking/vaping frequency (exploratory effectiveness outcome). This will be assessed as a composite outcome.
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Assessment method [18]
436819
0
Number of times smoking/vaping in the past 7 days
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Timepoint [18]
436819
0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [19]
436820
0
Access to health services (exploratory effectiveness outcome). This will be assessed as a composite outcome.
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Assessment method [19]
436820
0
Number of visits to health services in past 4 weeks, including GP visits, mental health clinicians, and attendance at hospital emergency.
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Timepoint [19]
436820
0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [20]
436821
0
Adoption - provider (implementation outcome)
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Assessment method [20]
436821
0
The research team will track number of prospective champions approached, who choose to take part, and withdrawals including reasons why through audit of recruitment records. Characteristics of champions will be collected via champion surveys designed specifically for this study.
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Timepoint [20]
436821
0
Continuous until end of trial
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Secondary outcome [21]
437107
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Quality of Life (exploratory effectiveness outcome)
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Assessment method [21]
437107
0
Assessment of Quality of Life-8
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Timepoint [21]
437107
0
Pre-intervention (0-weeks), post-intervention (8-weeks), one-month follow up (12-weeks).
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Secondary outcome [22]
437108
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Chronic Pain (exploratory effectiveness outcome)
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Assessment method [22]
437108
0
Brief Pain Inventory
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Timepoint [22]
437108
0
Pre-intervention (0-weeks), post-intervention (8-weeks), one month follow-up (12-weeks)
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Secondary outcome [23]
437109
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Anxiety
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Assessment method [23]
437109
0
Depression, Anxiety and Stress Scale-21
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Timepoint [23]
437109
0
Pre-intervention (0-weeks), Post-intervention (8-weeks), One-month follow-up (12-weeks)
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Secondary outcome [24]
437175
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Arachidonoyl ethanolamide (exploratory effectiveness outcome)
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Assessment method [24]
437175
0
Hair sample
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Timepoint [24]
437175
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Pre-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [25]
437176
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2-arachidonoyl glycerol (exploratory effectiveness outcome)
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Assessment method [25]
437176
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Hair sample
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Timepoint [25]
437176
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Pre-intervention (0-weeks), post-intervention (8-weeks)
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Secondary outcome [26]
437177
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Oleoylethanolamide (exploratory effectiveness outcome)
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Assessment method [26]
437177
0
Hair sample
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Timepoint [26]
437177
0
Pre-intervention (0-weeks), post-intervention (8-weeks)
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Secondary outcome [27]
437179
0
Palmitoylethanolamide (exploratory effectiveness outcome)
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Assessment method [27]
437179
0
Hair sample
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Timepoint [27]
437179
0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [28]
437180
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Stearoylethanolamide (exploratory effectiveness outcome)
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Assessment method [28]
437180
0
Hair sample
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Timepoint [28]
437180
0
Pre-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [29]
437182
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Lineoylethanolamide (exploratory effectiveness outcome)
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Assessment method [29]
437182
0
Hair sample
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Timepoint [29]
437182
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [30]
437183
0
Arachidonic acid (exploratory effectiveness outcome)
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Assessment method [30]
437183
0
Hair sample
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Timepoint [30]
437183
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [31]
437189
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Cortisol (exploratory effectiveness outcome)
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Assessment method [31]
437189
0
Hair sample
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Timepoint [31]
437189
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [32]
437190
0
Cortisone (exploratory effectiveness outcome)
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Assessment method [32]
437190
0
Hair sample
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Timepoint [32]
437190
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [33]
437191
0
Dehydropiandrosterone (exploratory effectiveness outcome)
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Assessment method [33]
437191
0
Hair sample
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Timepoint [33]
437191
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [34]
437192
0
Dehydropiandrosterone-sulfate (exploratory effectiveness outcome)
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Assessment method [34]
437192
0
Hair sample
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Timepoint [34]
437192
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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Secondary outcome [35]
437193
0
Progesterone (exploratory effectiveness outcome)
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Assessment method [35]
437193
0
Hair sample
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Timepoint [35]
437193
0
Post-intervention (0-weeks), Post-intervention (8-weeks)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Linear mixed effects model
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/09/2024
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Actual
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Date of last participant enrolment
Anticipated
30/01/2026
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Actual
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Date of last data collection
Anticipated
24/04/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
316768
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Government body
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Name [1]
316768
0
Medical Research Future Fund (MRFF 2023, Consumer Led Research), Department of Health and Aged Care
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Address [1]
316768
0
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Country [1]
316768
0
Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
318992
0
None
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Name [1]
318992
0
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Address [1]
318992
0
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Country [1]
318992
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315536
0
University of Melbourne Central Human Research Ethics Committee
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Ethics committee address [1]
315536
0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
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Ethics committee country [1]
315536
0
Australia
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Date submitted for ethics approval [1]
315536
0
24/01/2024
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Approval date [1]
315536
0
08/03/2024
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Ethics approval number [1]
315536
0
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135002
0
Dr Caitlin Hitchcock
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Address
135002
0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
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Country
135002
0
Australia
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Phone
135002
0
+61390353847
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Fax
135002
0
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Email
135002
0
[email protected]
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Contact person for public queries
Name
135003
0
Caitlin Hitchcock
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Address
135003
0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
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Country
135003
0
Australia
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Phone
135003
0
+61390353847
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Fax
135003
0
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Email
135003
0
[email protected]
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Contact person for scientific queries
Name
135004
0
Caitlin Hitchcock
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Address
135004
0
Redmond Barry Building, University of Melbourne, Parkville, VIC, 3010
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Country
135004
0
Australia
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Phone
135004
0
+61390353847
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Fax
135004
0
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Email
135004
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Outcome measures
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When will data be available (start and end dates)?
From the end of the trial, in perpetuity
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Available to whom?
Open Science Framework (OSF) users
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Available for what types of analyses?
Any purpose
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23957
Study protocol
387986-(Uploaded-04-07-2024-12-24-52)-Left Write Hook Protocol Version 3.docx
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.
Download to PDF