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Trial registered on ANZCTR


Registration number
ACTRN12617000085370
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
16/01/2017
Date last updated
17/10/2019
Date data sharing statement initially provided
17/10/2019
Date results information initially provided
17/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating working memory and decision-making deficits in children following traumatic brain injury.
Scientific title
Treating attention, speed of processing, decision-making, and working memory deficits in children following traumatic brain injury: Implementation of an attention and working memory intervention to improve adaptability and functional outcomes.
Secondary ID [1] 289824 0
None
Universal Trial Number (UTN)
U1111-1185-9761
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 299752 0
Condition category
Condition code
Injuries and Accidents 299685 299685 0 0
Other injuries and accidents
Neurological 299686 299686 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 300893 300893 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cogmed (RM version) is an adaptive working memory training program designed for children aged 7-15 years.The program involves 25 sessions carried out over approximately 5 weeks. Each session runs for 40- 50 minutes and comprises 8 different games. For the first five days, children train on the same games. On day 6 and every 5th day after this a new game is introduced, replacing one of the existing games.

The treatment group will be administered Cogmed (RM version).
- During the initial program appointment the coach provide an information statement to set up the program on the participants' home computer or ipad. At this meeting they will also assign each participant a unique ID number corresponding to the intervention and instruct the parent how to log into the online video conference platform.
- The coach will provide one weekly support every week of the training, to ensure that the training is progressing well and answer any questions from the families through any one of online video-conferencing platforms. The online video-conference would be scheduled in the initial start- up session with the families and would last for approximately 30 minutes. The coach can monitor the training and compliance by logging into a secure server. Program compliance can be assessed as the number of sessions completed by each child, and time spent per session will be recorded.
- The participants' parents will be their Cogmed Aide at home.
- The intervention will be delivered online.
- The intervention will include 25 sessions over a period of 5 weeks (i.e. 5 sessions each week). Each session will run for 40-50 minutes.
- The intervention will run in participants' home under the supervision of their parents.
Intervention code [1] 295499 0
Treatment: Other
Intervention code [2] 295500 0
Rehabilitation
Intervention code [3] 295501 0
Behaviour
Comparator / control treatment
The active control group will be administered Lexia(Registered Trademark) Reading, a program designed to target phonological awareness and phonics skills in reading but has no memory training component. Children will complete the program at home, and parents are asked to sit with their child during training to encourage task engagement and minimise environmental distractions. The program runs for 30 minutes per day, 5 days per week over the 8 week intervention period.

-The active control program will be administered online.
-The Coach will monitor child's adherence to the program by monitoring the training and compliance by logging into a secure server of the program.
-The Coach will provide weekly support, to ensure that the training is progressing well and answer any questions from the families through any one of online video-conferencing platforms.
Control group
Active

Outcomes
Primary outcome [1] 299147 0
Decision-Making .

Problem-Solving/Decision-Making Task ( Klayman, 1985).
Timepoint [1] 299147 0
Pre-intervention, immediately post-intervention and at 6 months post-intervention
Primary outcome [2] 300541 0
Working Memory

Automated Working Memory Assessment: Short-Form (AWMA: Alloway, 2012)
Timepoint [2] 300541 0
AWMA: Screening(2 sub tests), pre-intervention (remaining 2 sub tests), immediately post-intervention and at 6 months post-intervention.
Secondary outcome [1] 326315 0
Academic performance

Wide Range Achievement Test 4 (WRAT-4 : Wilkinson & Robertson, 2006)
Timepoint [1] 326315 0
Pre-intervention, immediately post-intervention and at 6months post intervention.
Secondary outcome [2] 326316 0
Adaptive Behaviour

Brief Rating Inventory of Executive Function (BRIEF: Gioia et al., 2000)


D.
Timepoint [2] 326316 0
BRIEF: Screening, Pre- intervention, Immediately post-intervention and at 6months post intervention.



Secondary outcome [3] 326317 0
Quality of Life

Paediatric Quality of Life Inventory - Parent version (Peds QL : Varni, 1999)
Timepoint [3] 326317 0
Pre-intervention, immediately post-intervention and at 6months post intervention.
Secondary outcome [4] 329300 0
Social Skills

Social Skills Improvement System Rating Scales- Teacher (SSIS Rating Scale-Teacher: Gresham & Elliott, 2008).

Timepoint [4] 329300 0
Pre-intervention, immediately post-intervention and at 6-months follow-up
Secondary outcome [5] 330271 0
Adaptive Behaviour

Child Behaviour Checklist (CBCL:Achenbach et al., 2001)
Timepoint [5] 330271 0
CBCL : Pre-intervention, immediately post-intervention and at 6 months post-intervention.
Secondary outcome [6] 330272 0
Adaptive Behavior

Teacher Rating Form (TRF: Achenbach et al., 2001)
Timepoint [6] 330272 0
TRF : Pre-intervention, immediately post-intervention and at 6 months post-intervention.
Secondary outcome [7] 334025 0
Working Memory: Wechsler Intelligence Scale for Children V: Working Memory sub tests (WISC-V: Wechsler, 2016)
Timepoint [7] 334025 0
Pre-intervention and at 6 months post-intervention.
Secondary outcome [8] 334026 0
Decision-Making : The Beads Task (Huq et al., 1988)
Timepoint [8] 334026 0
Pre-intervention, immediately post-intervention, and at 6 month post-intervention.

Eligibility
Key inclusion criteria
(1) attend primary and secondary school and be between the ages of 7-15 at the time of the intervention;
(2) sustained an TBI where there was head trauma associated with a) altered consciousness, as defined by Glasgow Coma Score and/or post traumatic amnesia, or b) intra-cranial abnormalities on brain scan, and,
(3) injury from acute stage onwards;and,
(4) evidence of reduced working memory or executive dysfunction at screening (1 SD below the mean)
(5) IQ>70
Minimum age
7 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) non-fluency in English;
(2) IQ below 70 at screening
(3) other previously documented neurological or learning difficulties diagnosis;
(4) severe sensory or physical impairment that affects their capacity to attend mainstream school and complete the training program: and,
(5) families and/or primary caregivers who are unable to support/assist their child through to the completion of the intervention program. This will be determined through discussions with primary caregivers/parents during the recruitment phase.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
For each intervention program, planned comparisons, using the SPSS General Linear Model procedure will compare pre- and post-intervention performance on the outcome measures and will examine age and sex effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6351 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 13897 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 294207 0
Charities/Societies/Foundations
Name [1] 294207 0
Collier Charitable Fund
Address [1] 294207 0
31/570 Bourke St,
Melbourne VIC 3000
Country [1] 294207 0
Australia
Primary sponsor type
Individual
Name
Cathy Catroppa
Address
Psychologist/Senior Research Fellow
Murdoch Childrens Research Institute
Royal Children’s Hospital
50, Flemington RD, Parkville Victoria, 3052
Australia.
Country
Australia
Secondary sponsor category [1] 293042 0
Individual
Name [1] 293042 0
Vicki Anderson
Address [1] 293042 0
Head of Psychology, RCH Mental Health
Theme Director, Clinical Sciences Research, MCRI
The Royal Children's Hospital Melbourne
50 Flemington Road Parkville Victoria 3052
Country [1] 293042 0
Australia
Other collaborator category [1] 279138 0
Individual
Name [1] 279138 0
Celia Godfrey
Address [1] 279138 0
Psychologist/Research Fellow
Murdoch Childrens Research Institute
Royal Children’s Hospital
50 Flemington Rd, Parkville Victoria, 3052
Australia.
Country [1] 279138 0
Australia
Other collaborator category [2] 279139 0
Individual
Name [2] 279139 0
Nikita Tuli
Address [2] 279139 0
PhD Candidate
Murdoch Childrens Research Institute
Royal Children’s Hospital
50 Flemington Rd, Parkville Victoria, 3052
Australia.
Country [2] 279139 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295615 0
Research Ethics & Governance. The Royal Children's Hospital. Melbourne
Ethics committee address [1] 295615 0
Research Ethics & Governance
The Royal Children's Hospital Melbourne
50 Flemington Road, Parkville,
3052, Victoria
Australia

Ethics committee country [1] 295615 0
Australia
Date submitted for ethics approval [1] 295615 0
06/04/2017
Approval date [1] 295615 0
11/04/2017
Ethics approval number [1] 295615 0
35181F

Summary
Brief summary
In children, acquired brain injury (ABI), and in particular traumatic brain injury (TBI), represents a common interruption to the course of normal development, with both international and local statistics citing an annual rate of 250–300 per 100,000 children (Kraus, 1995).

Working memory refers to the capacity to temporarily store information for use in everyday activities (Alloway et al., 2006). Decision-Making is conceived as a complex interplay of high-level cold cognitive processes such as working memory, information processing, problem-solving, and hot emotional processes (Cassotti et al., 2011; Reimann and Bechara, 2010). Efficient working memory and decision-making abilities are essential as they underpin one’s performance in functional skill areas such as academic, adaptive, behavioural and social domains (Catroppa & Anderson, 2006; Ganesalingam et al, 2011; Gathercole et al., 2006; Mandalis et al, 2007; Muscara et al., 2008).

Using a prospective, longitudinal design, adaptive abilities, behaviour, educational progress and everyday memory skills were investigated acutely post-injury and again at 12 and 30 months post-injury. Results suggested a strong association between injury severity and outcomes across all domains.With regard to social outcomes following childhood brain injury, deficits have been reported in many areas of social functioning and communication style, often resulting in low self-esteem, isolation, high rates of psychiatric disorder, criminal behaviour, and unemployment, and therefore poor integration into society (Anderson et al., 2009)

The overall aim of the proposed study is to enhance working memory and decision-making abilities and therefore potentially strengthen academic, social, behavioural and improving quality of life for children and adolescents post traumatic brain injury (TBI).

To achieve this aim, the objectives of the proposed study are:
(i) To evaluate the effectiveness of Cogmed using a randomized controlled trial (RCT) to investigate improvements in working memory and decision-making, in children post-TBI, compared to children in an active control group.
(ii) To determine whether these improvements in working memory and decision-making generalise into other areas of function and so also improve academic,social, behavioural, and quality of life outcomes.

It is hypothesized that
(i) Compared to children in the active control group, those children receiving Cogmed will display better working memory and decision-making skills immediately post-intervention and at 6 months post-intervention.
(ii) Improvements in working memory and decision-making will result in improvements in functional areas such as academic, social, behavioural and quality of life outcomes.
Trial website
Trial related presentations / publications
Presentations:
1. Decision-Making Neuroscience Symposium, the University of Melbourne
(Poster Presentation- October 2016)
2. 3rd Biennial Rehabilitation Conference of the Queensland Paediatric Rehabilitation Service – ‘Rehab for Kids – Shaping Futures Together’, Lady Cilento Children's Hospital
(Oral Presentation, November 2016)
3.Moving Ahead CRE Conference, the University of New South Wales
(Oral Presentation, December 2016)



Publications: In Submission:
Sood, N., Godfrey, C., Anderson, V., and Catroppa, C. Rehabilitation of Executive Function in Paediatric Traumatic Brain Injury (REPeaT): protocol for a randomized controlled trial for treating working memory and decision-making. BioMed Central Journal Paediatrics.
Public notes
Previously Ethics Approved protocol(HREC 35181F) was modified to include "social media" as a means of recruitment(July 2017) and Ethics Approval for this modification in the protocol (HREC 35181G) was received in August 2017.
Attachments [1] 1651 1651 0 0
Attachments [2] 2548 2548 0 0

Contacts
Principal investigator
Name 67522 0
A/Prof Cathy Catroppa
Address 67522 0
Psychologist/Research Fellow
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road, Parkville, Victoria, 3052
Australia.
Country 67522 0
Australia
Phone 67522 0
+61 03 99366638
Fax 67522 0
Email 67522 0
cathy.catroppa@mcri.edu.au
Contact person for public queries
Name 67523 0
Ms Nikita Tuli
Address 67523 0
PhD Candidate
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road, Parkville, Victoria, 3052
Australia.
Country 67523 0
Australia
Phone 67523 0
+61 03 99366395
Fax 67523 0
Email 67523 0
nikita.tuli@mcri.edu.au
Contact person for scientific queries
Name 67524 0
A/Prof Cathy Catroppa
Address 67524 0
Psychologist/Research Fellow
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road, Parkville, Victoria, 3052
Australia.
Country 67524 0
Australia
Phone 67524 0
+61 03 99366638
Fax 67524 0
Email 67524 0
cathy.catroppa@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary