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Trial registered on ANZCTR


Registration number
ACTRN12622001512718
Ethics application status
Approved
Date submitted
30/11/2022
Date registered
6/12/2022
Date last updated
28/02/2023
Date data sharing statement initially provided
6/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Online delivered acceptance and commitment therapy (ACT) for managing anxiety in adolescents with traumatic brain injury
Scientific title
Evaluation of an online delivered acceptance and commitment therapy (ACT) program for managing anxiety in adolescents with traumatic brain injury: A feasibility and pilot randomised controlled trial
Secondary ID [1] 308517 0
Nil known
Universal Trial Number (UTN)
U1111-1285-5219
Trial acronym
ACT4teens
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 328341 0
anxiety 328342 0
Condition category
Condition code
Injuries and Accidents 325378 325378 0 0
Other injuries and accidents
Neurological 325379 325379 0 0
Other neurological disorders
Mental Health 325429 325429 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being evaluated is the Discoverer, Noticer, Advisor –Vitality program (DNA-V; Hayes & Ciarrochi, 2015) which is based on the acceptance and commitment therapy (ACT) model.

The program focuses on developing three main skills: Discovering, Noticing and Advising. Key components of the program include helping adolescents to notice and connect with their feelings (Noticing skills), use their thoughts or self-talk in useful ways (Advising skills), and engage in new behaviours that are consistent with their values (Discovering skills). For example, adolescents focus on how to use their self-talk in helpful ways. They learn to listen when their self-talk is helpful, and defuse (distance themselves) from it when it is not helpful.

The activities used in the program have been adapted to address the cognitive difficulties experienced by people with TBI. Information will be presented both verbally and visually whenever possible. The skills will be learnt in structured sessions with the opportunity to apply them in their everyday life. For the adaptation, our clinical team reviewed the activities within the DNA-V program and identified those which may be most suitable for this population. For example, activities which rely more on visual prompts or have written aids like card sorting activities. These activities were identified as a pool of learning tools for the implementation of the program.

The program will consist of eight 1 hour weekly sessions delivered via video call and provided on a one-to-one format. It will be delivered by a registered psychologist experienced in working with children and adolescents with TBI. A hard copy of the workbook, worksheets, and other materials will be provided to the participant at the beginning of the program. The online share screen and white board function will be used to work through session materials when needed.

The workbook and worksheets are based on materials available from the DNA-V program (Hayes & Ciarrochi, 2015). The adolescent will be required to complete worksheets/activities between sessions. Time to complete these activities will vary week to week but they will typically take 20-25 minutes to complete throughout the week. To support adherence to the home tasks, at the end of each session, the therapist will go through the home task for the week ahead to plan how the adolescent will complete the task.

Consistency of the delivery of the program will be ensured as all therapists will be working from a therapy manual with each session planned. A ‘Therapy Session Log’ will be completed by the therapist after each session documenting the content covered during the session. Adherence to the program will be ensured through the independent evaluation of the ‘Therapy Session Log’. At the end of the data collection period, an independent member of the research team will review the Therapy Session Log and rate each session using a study adherence checklist. The checklist will assess whether the therapist and participant have covered each of the key components of the therapy program.

Reference: Hayes, L., & Ciarrochi, J. (2015). The thriving adolescent: Using acceptance and commitment therapy and positive psychology to help young people manage emotions, achieve goals and build positive relationships. Oakland, CA: Context Press.
Intervention code [1] 324957 0
Treatment: Other
Intervention code [2] 324958 0
Rehabilitation
Intervention code [3] 324959 0
Behaviour
Comparator / control treatment
An active waitlist control group will be used in this study with outcome assessments for intervention and control groups conducted at pre-treatment, post-treatment and 3-months follow-up.

Participants in the control group will receive usual care. Usual care is defined as clinic appointments with the brain injury rehabilitation team as determined by the team. Control participants will be allowed access to treatment as usual as available.

Participants in the control group will be offered the program as soon as they complete the three month follow-up assessment, which is approximately 5 months from the time of study entry.
Control group
Active

Outcomes
Primary outcome [1] 333249 0
Anxiety symptoms assessed using the Spence Children’s Anxiety Scale (SCAS)
Timepoint [1] 333249 0
Pre-treatment, immediately post-treatment (primary time-point) and 3-month follow-up
Secondary outcome [1] 416336 0
Mindfulness or 'noticing skills' assessed using the Child and Adolescent Mindfulness Measure (CAMM)
Timepoint [1] 416336 0
Pre-treatment, immediately post-treatment and 3-month follow-up
Secondary outcome [2] 416338 0
Psychological acceptance assessed using the Acceptance and Fusion Questionnaire for Youth (AFQ-Y)
Timepoint [2] 416338 0
Pre-treatment, immediately post-treatment and 3-month follow-up
Secondary outcome [3] 416339 0
Self-perception assessed by the Self-Perception Profile for Adolescents (SPPA)
Timepoint [3] 416339 0
Pre-treatment, immediately post-treatment and 3-month follow-up
Secondary outcome [4] 416340 0
Valued living assessed by the Six Ways to Wellbeing Measure (6WWM)
Timepoint [4] 416340 0
Pre-treatment, immediately post-treatment and 3-month follow-up
Secondary outcome [5] 416341 0
Psychosocial functioning assessed by the Sydney Psychosocial Reintegration Scale for Children (SPRS-C)
Timepoint [5] 416341 0
Pre-treatment, immediately post-treatment and 3-month follow-up
Secondary outcome [6] 416345 0
Therapy session evaluation assessed by the Session Rating Scale
Timepoint [6] 416345 0
After each session
Secondary outcome [7] 416498 0
Therapy session evaluation assessed by the E-health Session Evaluation
Timepoint [7] 416498 0
After each session
Secondary outcome [8] 416499 0
Acceptability of the program assessed by the Abbreviated Acceptability Rating Profile
Timepoint [8] 416499 0
Immediately post-treatment

Eligibility
Key inclusion criteria
Inclusion criteria are:

(1) 12-17 years old,
(2) sustained a complicated mild, moderate or severe TBI where there was head trauma associated with a) altered consciousness, as defined by Glasgow Coma Score (GCS) and/or post traumatic amnesia (PTA), or b) intra-cranial abnormalities on a brain scan,
(3) anxiety as measured by a score of 1 SD above mean or greater on the Spence Children Anxiety Scale (SCAS) and
(4) time post-injury greater than 6 months
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
(1) non-fluency in English,
(2) severe cognitive impairment as determined by scores of lower than two standard deviations below the mean on a measure of general cognitive functioning (e.g., Wechsler Intelligence Scale for Children) and
(3) other neurological, developmental or behavioural disorder pre-existing to the TBI, which will be determined through the completion of a semi-structured interview at study enrolment.

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)
Allocation to groups will be concealed.

Randomisation will be conducted by an independent member of our research team who will not be located at the recruitment sites (the Children's Hospitals) and will not be involved in the therapy/assessments. We will use block randomisation in groups of 4 in order to achieve a balance of participants between treatments. Participant identification numbers will be written on the outside of opaque envelopes. A computer-generated series of random numbers will be used to allocate participants to treatment condition. Codes for the group condition (1=Treatment, 2=Control) will be sealed in the relevant participants’ envelopes. Prior to the commencement of therapy, a designated treating clinician will contact the independent team member who will indicate to which condition each participant is assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use block randomisation in groups of 4 in order to achieve a balance of participants between treatments. A computer-generated series of random numbers will be used to allocate participants to treatment condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. The main statistical analyses will be a series of repeated measures analyses of variance (ANOVAs). The first factor, Group, will have two levels (Treatment versus Control). The second factor, Time, is a within subjects, repeated measures factor. The ANOVAs will be conducted examining the following outcomes: (1) anxiety (SCAS), (2) other measures of psychological wellbeing (CAMM, SPPA, 6WWB, AFQ-Y) and (3) psychosocial functioning (SPRS-C).

No published data evaluating ACT for treating anxiety in adolescents with TBI are available. However, a relevant published study has evaluated cognitive behavioural therapy (CBT) for managing social anxiety in adults with TBI (Hodgson et al., 2005). Relative to pre-treatment, Hodgson et al.(2005) found a reduction between treatment and control groups on the anxiety subscale on the Depression and Anxiety Scales (DASS) at post-treatment with a large effect size evident. A sample size calculation with EF=2.09, power = 0.85 and alpha level = 0.05 indicates a sample of n=6 in each group is adequate to detect a treatment effect.

Reference: Hodgson, J., McDonald, S., Tate, R., & Gertler, P. (2005). A Randomised Controlled Trial of a Cognitive-Behavioural Therapy Program for Managing Social Anxiety After Acquired Brain Injury. Brain Impairment, 6(3), 169-180.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23658 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 23659 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 39080 0
2145 - Westmead
Recruitment postcode(s) [2] 39081 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 312756 0
Government body
Name [1] 312756 0
icare NSW
Country [1] 312756 0
Australia
Primary sponsor type
Hospital
Name
South Western Sydney Local Health District (SWSLHD)
Address
Administration Building, Eastern Campus, Liverpool Hospital
Locked Bag 7279, Liverpool BC 1871
Country
Australia
Secondary sponsor category [1] 314440 0
None
Name [1] 314440 0
Address [1] 314440 0
Country [1] 314440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312058 0
Sydney Children's Hospital Network Research Ethics Committee
Ethics committee address [1] 312058 0
Ethics committee country [1] 312058 0
Australia
Date submitted for ethics approval [1] 312058 0
02/05/2022
Approval date [1] 312058 0
04/08/2022
Ethics approval number [1] 312058 0
2022/ETH00803

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

Contacts
Principal investigator
Name 123310 0
Dr Cheryl Soo
Address 123310 0
Brain Injury Rehabilitation Research Group
Ingham Institute for Applied Medical Research
1 Campbell Street,
Liverpool NSW 2170
Country 123310 0
Australia
Phone 123310 0
+61 450 895 360
Fax 123310 0
Email 123310 0
cheryl.soo@mcri.edu.au
Contact person for public queries
Name 123311 0
Cheryl Soo
Address 123311 0
Brain Injury Rehabilitation Research Group
Ingham Institute for Applied Medical Research
1 Campbell Street,
Liverpool NSW 2170
Country 123311 0
Australia
Phone 123311 0
+61 450 895 360
Fax 123311 0
Email 123311 0
cheryl.soo@mcri.edu.au
Contact person for scientific queries
Name 123312 0
Cheryl Soo
Address 123312 0
Brain Injury Rehabilitation Research Group
Ingham Institute for Applied Medical Research
1 Campbell Street,
Liverpool NSW 2170
Country 123312 0
Australia
Phone 123312 0
+61 450 895 360
Fax 123312 0
Email 123312 0
cheryl.soo@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical clearance to share participant data.


What supporting documents are/will be available?

No Supporting Document Provided



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.