Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000965707p
Ethics application status
Not yet submitted
Date submitted
23/06/2022
Date registered
8/07/2022
Date last updated
8/07/2022
Date data sharing statement initially provided
8/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Neurofeedback for Indigenous children with complex post-traumatic stress disorder in out of home care: A pre-post experimental trial
Scientific title
The efficacy of neurofeedback for Indigenous children with complex post-traumatic stress disorder in out of home care: A pre-post experimental trial
Secondary ID [1] 307427 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex post-traumatic stress disorder 326777 0
Condition category
Condition code
Mental Health 323998 323998 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neurofeedback, also known as EEG (electroencephalogram) biofeedback, is a therapeutic intervention that provides immediate feedback from a computer-based program that assesses a client’s brainwave activity. The program then uses sound or visual signals to reorganize or retrain these brain signals. By responding to this process, clients learn to regulate and improve their brain function and to alleviate symptoms of various neurological and mental health disorders.
Participants will sit relaxed on a chair with back support with two EEG sensors connected to a computer with EEGer software downloaded via an A202 amplifier (Neurofeedback International Academy, Victoria, Australia). The impedance of all electrodes will be kept at under 15 kO and placed according to the international 10/20 system. A neurofeedback specific assessment will be completed including a ‘mini-map’ and initial site of training will be as per Dr Susan Othmer’s protocol guide. The mini-map will be repeated at midpoint and completion.
The frequency of reward and inhibit bands will be set after assessment of the posterior dominant rhythm; this will be individualised and guided by expert supervisors’ input (co-investigators and neurofeedback clinicians from the Australian Neurofeedback Institute). The software allows for insertion of culturally appropriate images, or even the child’s own drawings. 32 sessions will be offered over 24 weeks, the first 24 sessions will be twice weekly and the final 8 sessions to be held weekly. (4 weeks grace has been built into the trial to allow for likely cancellations due to the pandemic.) Each session will be 30-45 minutes long, settling each child and attaching sensors takes a variable duration. As is standard practice in neurofeedback, if a child is outside of 40-55% reward band for longer than approximately 20 seconds the system will be re-calibrated to achieve the most ideal settings to maximise learning (40-55% of time in reward state).The neurofeedback will run for 20-30 mins dependent upon the training going towards improvements and the child not tiring. Adjustments to the protocol will be based on caregiver and child reports and clinical judgment. All foster parents will receive standard neurofeedback psychoeducation (as per training received at the course offered by the Australian Neurofeedback Institute). Foster parents will be guided to encourage their children complete regular home based relaxation practice (such as using a slow breathing app) but achieving this will be left to the discretion of the carer. If carers ring for support due to their child becoming agitated, they will be reminded of the relaxation practice. Their feedback regarding symptoms for the 48 hours after treatment will be incorporated into treatment planning as is standard for this model of care. Fidelity of treatment will be guided by expert supervisors.
Intervention code [1] 323862 0
Treatment: Devices
Comparator / control treatment
No control group. This trial will use a pre-post design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331793 0
Change in complex post-traumatic stress disorder symptoms as assessed by the International Trauma Questionnaire.
Timepoint [1] 331793 0
At baseline, then after completion of 16 and 32 sessions of neurofeedback and finally at 4 weeks follow up post intervention completion.
Secondary outcome [1] 411158 0
Change in self concept as assessed by the Piers-Harris Self-concept Scale, third edition.
Timepoint [1] 411158 0
At baseline and then after completion of 32 session intervention
Secondary outcome [2] 411159 0
Change in EEG 'minimap'
Timepoint [2] 411159 0
At baseline, then after completion of 16 and 32 sessions of neurofeedback.
Secondary outcome [3] 411160 0
Change in academic, behaviour and social function as assessed by the Connors Parent and Teacher Short Form, third edition.
Timepoint [3] 411160 0
At baseline and then after completion of 32 session intervention.
Secondary outcome [4] 411161 0
Change in foster carer stress as assessed by the Depression, Anxiety and Stress Scale (DASS-21).
Timepoint [4] 411161 0
At baseline and then after their foster child has completed 32 session intervention.
Secondary outcome [5] 411340 0
Change in foster carer confidence in parenting as assessed by the Parenting Sense of Competence Scale.
Timepoint [5] 411340 0
At baseline and then after their foster child has completed 32 sessions of neurofeedback.

Eligibility
Key inclusion criteria
Children will be included if they are Aboriginal, aged 6-17, have experienced at least one interpersonal traumatic event such as abuse or neglect and have clinically significant cPTSD.
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded if they have a known history of epilepsy, or head injury; if they have received neurofeedback treatment in the past 5 years; if they are currently prescribed a benzodiazepine; or if there has been a serious suicide attempt in the previous six months.

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Pre-post design
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To assess the impact of neurofeedback on International Trauma Questionnaire (ITQ) scores, the data will first be visualised to observe and compare score distributions with histograms and boxplots. Score trajectories over time will also be described with spaghetti-plots. Statistical significance of mean differences between any time points will be estimated using the paired t-test. With 30 subjects, if the effect size was at least 0.55, we would have 80% power to declare that the mean of the paired differences is significantly different from zero (i.e. two sided p-value < 0.05). Next, piecewise multilevel growth curve modelling (GCM) will be conducted to examine change in subscales of ITQ- the Disturbances in Self and Other (DSO) trauma-related symptoms through the course of treatment (individual DSO sub-scores of ITQ). Multilevel GCMs have become the standard for analysing psychotherapy outcome data because of several advantages such as the capacity to handle missing data and unbalanced information, efficient and modelling flexibility. This approach is recommended by the Institute of Medicine (2001) for small clinical trials to maximize data use while obtaining reliable and valid results. Modelling and model fitting and evaluation will be implemented using mixed-effect linear model regression with the R Statistical Package lme4. Piecewise growth modelling examined change during treatment and during follow-up. Two time variables were included in the analyses: The primary time begins at zero (baseline assessment) and increased by one for subsequent assessments; and a variable coded zero for all the assessments that occurred during treatment and coded one for the follow-up assessment. This model produces three coefficients: The regression intercept represents baseline scores; the first-time parameter for changes during treatment; and the second time parameter for the difference in rate of change during treatment and during the follow-up period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37871 0
2287 - Elermore Vale

Funding & Sponsors
Funding source category [1] 311699 0
Charities/Societies/Foundations
Name [1] 311699 0
Hunter Children's Research Foundation
Country [1] 311699 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Rd,
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 313156 0
None
Name [1] 313156 0
Address [1] 313156 0
Country [1] 313156 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311152 0
Aboriginal Health and Medical Research Council Ethics Committee
Ethics committee address [1] 311152 0
Ethics committee country [1] 311152 0
Australia
Date submitted for ethics approval [1] 311152 0
05/07/2022
Approval date [1] 311152 0
Ethics approval number [1] 311152 0

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

Contacts
Principal investigator
Name 120126 0
Dr Beth Mah
Address 120126 0
University of Newcastle, Centre for Brain and Mental Health
Room 6015, Mater Mental Health Administration,
Edith St, Waratah, NSW, 2298
Country 120126 0
Australia
Phone 120126 0
+61 02 49575900
Fax 120126 0
Email 120126 0
[email protected]
Contact person for public queries
Name 120127 0
Beth Mah
Address 120127 0
Wandiyali,
116 Lake Rd,
Elermore Vale, NSW 2287
Country 120127 0
Australia
Phone 120127 0
+61 02 49575900
Fax 120127 0
Email 120127 0
[email protected]
Contact person for scientific queries
Name 120128 0
Beth Mah
Address 120128 0
University of Newcastle, Centre for Brain and Mental Health,
Room 6015, Mater Mental Health Administration,
Edith St, Waratah, NSW, 2298
Country 120128 0
Australia
Phone 120128 0
+61 02 49575900
Fax 120128 0
Email 120128 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?
All de-identified data assuming approval by the Aboriginal research governance committee
When will data be available (start and end dates)?
Available from 30/12/2023 (at completion of study) for 5 years after completion (30/12/2028)
Available to whom?
To be determined by the Aboriginal research governance committee
Available for what types of analyses?
To be determined by the Aboriginal research governance committee
How or where can data be obtained?
To be determined by the Aboriginal research governance committee


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16462Study protocol    384267-(Uploaded-23-06-2022-20-34-17)-Study-related document.docx
16463Statistical analysis plan    384267-(Uploaded-23-06-2022-20-34-54)-Study-related document.docx
16464Informed consent form    384267-(Uploaded-23-06-2022-20-35-11)-Study-related document.docx
16465Ethical approval    To be uploaded when available



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.