Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001550392
Ethics application status
Approved
Date submitted
31/10/2017
Date registered
10/11/2017
Date last updated
17/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of a Novel Online Cognitive Rehabilitation Program for Children with Cerebral Palsy
Scientific title
A Randomised Controlled Trial on the effect of a Novel Online Cognitive Rehabilitation Program on Cognitive Functioning in Children with Cerebral Palsy
Secondary ID [1] 293149 0
Nil known
Universal Trial Number (UTN)
U1111-1203-8413
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 305127 0
Condition category
Condition code
Mental Health 304445 304445 0 0
Learning disabilities
Neurological 304446 304446 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel online cognitive rehabilitation program (S.M.A.R.T.) has been developed by psychologists Dr Bryan Roche and Dr Sarah Cassidy to target a cognitive skill, relational framing. Relational frame theory suggests human language and complex cognition is underpinned by our ability to relate stimuli arbitrarily, and to derive relationships between novel stimuli.
This intervention involves children answering logical problems that directly train relational framing through an online, user-friendly platform. An example of such a problem would be, If B is larger than C,and A is larger than B, is C less than or more than A? Children receive immediate feedback on their answers. Participants will engage in the intervention from their own homes, using deidentified log-ins to access the web-based platform. They will work through the program for 1.5 hours a week, over three 30-minute sessions until 70 modules with problems of increasing complexity are completed and full dosage is received. Up to 5 modules may be completed within a 24-hour period. A psychologist will follow the progress of each participant through the online platform.
Intervention will be completed within 20 weeks, and follow-up assessment will be undertaken 40 weeks post baseline.
Intervention code [1] 299398 0
Rehabilitation
Intervention code [2] 299399 0
Behaviour
Comparator / control treatment
All participants will undertake baseline assessment before random allocation to either the intervention or wait-list control group. A wait-list control will receive access to the intervention after follow-up assessment has been completed at 20 weeks post baseline assessment. The wait-list control group will receive care as usual during the wait-list period. Usual care refers to any physical or psychological therapy or treatment the child would normally receive outside of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 303745 0
Change in intellectual functioning, as assessed by score on the Wechsler Intelligence Scale for Children - Fifth Edition.
Timepoint [1] 303745 0
Primary outcome - score difference between baseline and immediately post-intervention (20 weeks post baseline; Will also assess retention of effect at 40 weeks post baseline.)
Secondary outcome [1] 340042 0
Change in performance on tests of academic achievement - Wechsler Individual Achievement Test - Third Edition.
Timepoint [1] 340042 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)
Secondary outcome [2] 340045 0
Change in executive functioning as measured by the Behavior Rating Inventory of Executive Function (BRIEF).
Timepoint [2] 340045 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)
Secondary outcome [3] 340046 0
Change in behavioural symptoms, as measured by the Strengths and Difficulties questionnaire.
Timepoint [3] 340046 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)
Secondary outcome [4] 340049 0
Change in child ADHD symptoms, as measured by the Conners-3.
Timepoint [4] 340049 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)
Secondary outcome [5] 340050 0
Change in adaptive behaviours, as measured by the Behavior Assessment System for Children - 3rd edition.
Timepoint [5] 340050 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)
Secondary outcome [6] 340051 0
Change in communication skills and social functioning, as measured by the Social Communication Questionnaire.
Timepoint [6] 340051 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)
Secondary outcome [7] 340269 0
Change in quality of life score as measured by the Cerebral Palsy Quality of Life - Child questionnaire.
Timepoint [7] 340269 0
Baseline, Immediately post-intervention (20 weeks post baseline) and retention (40 weeks post baseline)

Eligibility
Key inclusion criteria
Children with Cerebral Palsy (GMFCS I-III) aged 8-12 years old living in Queensland who are able to attend assessment sessions in Brisbane.
Must be able to access online program and perform tasks on iPad, tablet, Mac or PC.
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unstable epilepsy
-unstable brain injury (e.g, degenerative or metabolic condition)
- active medical condition (e.g. chemotherapy, radiotherapy, or neurosurgical).

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)
Sealed opaque envelopes will be used to ensure that the investigator who determines eligibility of a participant is unaware when making this decision of the group the participant would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation via computer sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants assigned to one of two groups - Intervention or Waitlist control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Study hypotheses will be analysed by means of appropriate statistical tests, with statistical significance set at p<0.05 for all tests, with adjustment for multiple comparisons, and all analyses will be by intention to treat. Mixed analysis of variance analyses will be conducted with time (baseline, 20 weeks and 40 weeks) as the within subjects variable, and group (intervention or waitlist) as the between subjects variable. Secondary analysis will profile cognitive change over time for participants based on their test scores. Preliminary analysis suggests a total sample size of 52 would be sufficient to equate to a medium-large effect size of 0.70 (power 0.8). Therefore we aim to recruit 60 participants to account for attrition (30 in each group).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2018
Actual
21/06/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
60
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9248 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 17910 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 297775 0
University
Name [1] 297775 0
The University of Queensland
Country [1] 297775 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 296813 0
Hospital
Name [1] 296813 0
Queensland Paediatric Rehabilitation Service, Lady Cilento Children's Hospital
Address [1] 296813 0
501 Stanley Street
South Brisbane, QLD, 4101
Country [1] 296813 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298836 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 298836 0
Children’s Health Queensland Hospital and Health Service
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct, South Brisbane QLD 4101
Ethics committee country [1] 298836 0
Australia
Date submitted for ethics approval [1] 298836 0
17/11/2014
Approval date [1] 298836 0
18/12/2014
Ethics approval number [1] 298836 0
HREC/14/QRCH/377

Summary
Brief summary
This project aims to test the effectiveness of a new online cognitive rehabilitation program known as S.M.A.R.T (Strengthening Mental Abilities with Relational Training) in children with Cerebral Palsy. The study will consist of a randomised controlled trial involving 60 participants, assigned to either the intervention group or a waitlist control. By the end of the study, all participants will have received access to the program. We predict that the S.M.A.R.T. program will be associated with improvements in performance on tests of intellectual functioning, academic achievement, and executive function, as well as measures of emotional and behavioural difficulties. Outcomes will be assessed at baseline, immediately after treatment ends (20 weeks post baseline) and at 40 weeks, to measure retention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78390 0
Dr Koa Whittingham
Address 78390 0
Level 6, Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane Queensland 4101 Australia
Country 78390 0
Australia
Phone 78390 0
+61 7 3069 7346
Fax 78390 0
Email 78390 0
[email protected]
Contact person for public queries
Name 78391 0
Ms Jane Wotherspoon
Address 78391 0
Level 6, Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane Queensland 4101 Australia
Country 78391 0
Australia
Phone 78391 0
+61 7 3069 7367
Fax 78391 0
Email 78391 0
[email protected]
Contact person for scientific queries
Name 78392 0
Dr Koa Whittingham
Address 78392 0
Level 6, Centre for Children's Health Research (CCHR)
62 Graham Street
South Brisbane Queensland 4101 Australia
Country 78392 0
Australia
Phone 78392 0
+61 7 3069 7346
Fax 78392 0
Email 78392 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of a novel online cognitive rehabilitation programme for children with cerebral palsy: A study protocol.2019https://dx.doi.org/10.1136/bmjopen-2018-028505
N.B. These documents automatically identified may not have been verified by the study sponsor.