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Trial registered on ANZCTR


Registration number
ACTRN12616001414404
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
11/10/2016
Date last updated
13/04/2024
Date data sharing statement initially provided
21/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot intervention for attention, memory, and social problems after an acquired brain injury in children and adolescence.
Scientific title
A pilot intervention program for cognitive and social sequelae following Acquired Brain Injury in childhood and adolescence.
Secondary ID [1] 289653 0
Nil known
Universal Trial Number (UTN)
U1111-1184-7768
Trial acronym
Amat-c
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 299451 0
Condition category
Condition code
Injuries and Accidents 299432 299432 0 0
Other injuries and accidents
Neurological 299434 299434 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Amsterdam Memory and Attention Training for children (Amat-c) is a cognitive training program for enhancing children’s attention, memory, and executive functioning (EF) skills. This is a restorative or direct intervention that is designed to treat the consequences of ABI, and requires an initial evaluation to identify impaired abilities. The child is trained, using specific exercises focusing on deficient cognitive abilities, in an attempt to improve these skills, as well as to impact more generally on cognitive functions.

The task undertaken by the child are presented in three phases:

Phase 1—Sustained attention. Training methods focus on learning to concentrate on one task for a period of time. Example: Listening to the clock: The clock’s ticking is counted. The distance from the clock is increased and the task repeated until the child is not able to complete the task. The first and the final distance from the clock are measured.

Phase 2—Selective attention. Focused (e.g. ignore distraction) and divided attention (e.g. focusing attention quickly and flexibly). Example: ABCDE Method: The Child is taught the ABCDE Method for approaching a task. A, Appreciating; B, Being Critical; C, Concentrating, D, Deep Thinking, E, Evaluating.

Phase 3—Mental tracking and memory. Techniques to assist memory, including repetition, coding/sorting and visual imagery. Example: Memory—Repeating and Sorting: The child is involved in tasks that require repetition of information and sorting of information in order to enhance memory skills.

The Amat-c will be administered to participating families in the treatment group for a period of 18 weeks. Each week will be preceded by a 1hour clinician-support session. During these sessions, a clinician will call participating families via a video call to explain the techniques and instructions for the Amat-c activities for that week. The clinician will also address any concerns arising from the previous week’s activities (commencing from week two).

Following this, the Amat-c program will be delivered by a parent for the rest of the week, in a daily 30 minute session. Parents will coach this session using relevant sections the Amat-c Handbook provided for the respective week’s activities.

Adherence to the intervention will be monitored during the weekly call sessions with the clinician. Here, specific questions will be asked as to whether the exercises were completed and any potential challenges associated with each exercise will be addressed. In addition, we will evaluate adherence to the protocol by assessing the parent’s responses to questions about their likes and dislikes for each week’s activities, entered in a section of the workbook. All workbooks completed by the parent and child during the weekly activities will be collected at the post-intervention outcome assessment session, and will be another source of evaluation of adherence to the intervention.
Intervention code [1] 295278 0
Treatment: Other
Intervention code [2] 295279 0
Rehabilitation
Intervention code [3] 295280 0
Behaviour
Comparator / control treatment
An active control group with ABI will be included in this study. This group will be asked to read the content of a psycho-education booklet on common behaviour problems associated with childhood ABI. This booklet is designed for the purpose of this study and will include sections on headache, fatigue, sleep disturbances, dizziness and emotional problems, as well as sections on how parents can assist their child in each of these domains. Parents will be required to read this booklet.

Subsequently, a clinician will conduct a weekly video or audio call to discuss these topics and any potential problems encountered by the family in a given domain. Each weekly call will involve a one-on-one session with the clinician and will be for a maximum of 1hour.

The control group will only be administered the Amat-c program once all data collection is complete and the feasibility and efficacy of the program is confirmed. Thus, post outcome assessment. This is expected to be approximately 9 months after the intervention group has completed the program.
Control group
Active

Outcomes
Primary outcome [1] 298904 0
Memory: assessed using the mean scores on pre-selected subtests of the Children’s Memory Scale)
Timepoint [1] 298904 0
Screening, immediately post-intervention, and at 6months post intervention.
Primary outcome [2] 298905 0
Attention: assessed using the mean scores on pre-selected subtest of the Everyday Attention for Children (TEA-Ch)
Timepoint [2] 298905 0
Screening, immediately post-intervention, and at 6months post intervention.
Secondary outcome [1] 325617 0
Adaptive Behabior: assessed with the Vineland Adaptive Behaviour Scales- Second Edition (Vineland-II) - Parents form
Timepoint [1] 325617 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [2] 325618 0
Functional memory: measured with selected subtests of the Rivermead Behavioural Memory Test-Third Edition,
Timepoint [2] 325618 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [3] 325619 0
Prospective memory, assessed with the Prospective and Retrospective Memory Questionnaire (PRMQ)
Timepoint [3] 325619 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [4] 325620 0
Academic performance: assessed with the Wide Range Achievement Test 4 (WRAT-4)
Timepoint [4] 325620 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [5] 325621 0
Affect recognition: assessed with the Developmental Neuropsychological Assessment-II (NEPSY-II; Affect Recognition subtest)
Timepoint [5] 325621 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [6] 325622 0
Proxy memory assessment: Assessed using the parent form of the Observer Memory Questionnaire (OMQ)
Timepoint [6] 325622 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [7] 325623 0
Behavior: Assessed using the parent and teacher forms of the Behaviour Assessment System for Children (BASC).
Timepoint [7] 325623 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [8] 325624 0
Executive functioning: assessed with the Brief Rating Inventory of Executive Function (BRIEF), parents and teacher forms.
Timepoint [8] 325624 0
Immediately post-intervention and at 6months post intervention.
Secondary outcome [9] 325625 0
Qulaity of life: assessed with the Paediatric Quality of Life Inventory (PedsQL) Generic Core Scale- Parent form
Timepoint [9] 325625 0
Immediately post-intervention and at 6months post intervention.

Eligibility
Key inclusion criteria
Eligible participants will:

(a) have an ABI diagnosis.
(b) be between the ages of 8-16 at the time of the intervention.
(c) be a minimum of 1 year post-injury.
(d) have an IQ of 70 or above.
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if:

They present with no attention and memory difficulties ton the screening tasks.
They do not meet the eligibility criteria during the screening (e.g. IQ below the score of 70).

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
This trail will include 20 participants each in the intervention and control groups. Based on a priori power estimation on the Childrens Memory and Attention Scale, we estimate that this sample size will allow us to detect a difference in verbal and visual working memory at a power of 80%. alpha value of 0.05, and an effect size of 0.90.

For each intervention program, repeated measures multivariate planned comparisons, using the SPSS, GLM procedure will compare pre-and-post intervention and 6-month follow-up performance on the outcome measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/11/2017
Actual
28/11/2017
Date of last participant enrolment
Anticipated
1/12/2027
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 6153 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 13593 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 294042 0
Charities/Societies/Foundations
Name [1] 294042 0
The Telematics Trust
Country [1] 294042 0
Australia
Primary sponsor type
Individual
Name
Cathy Catroppa (Asso Prof)
Address
Psychologist/Research Fellow
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria, 3052,
Australia
Country
Australia
Secondary sponsor category [1] 292863 0
Individual
Name [1] 292863 0
Prof Vicki Anderson
Address [1] 292863 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] 292863 0
Australia
Secondary sponsor category [2] 292865 0
Individual
Name [2] 292865 0
Nicholas Ryan
Address [2] 292865 0
Clinical Neuropsychologist , Murdoch Children's Research Institute, The Royal Children's Hospital, Melbourne, 50 Flemington Road, Parkville, Victoria 3052.
Country [2] 292865 0
Australia
Secondary sponsor category [3] 292866 0
Individual
Name [3] 292866 0
Dr Edith Botchway
Address [3] 292866 0
Honorary Research Fellow, Murdoch Children's Research Institute, The Royal Children's Hospital, Melbourne, 50 Flemington Road, Parkville, Victoria 3052.
Country [3] 292866 0
Australia
Secondary sponsor category [4] 292867 0
Individual
Name [4] 292867 0
Dr Stefanie Rosema
Address [4] 292867 0
Post-doctoral Researcher and Clinician
Sophia Revalidatie Den Haag
Vrederustlaan 180
2543 SW Den Haag
Country [4] 292867 0
Netherlands
Secondary sponsor category [5] 292868 0
Individual
Name [5] 292868 0
Dr Cheryl Soo
Address [5] 292868 0
Clinical Psychologist and Research Fellow
Murdoch Childrens Research Institute
50 Flemington Road Parkville Victoria 3052
Country [5] 292868 0
Australia
Secondary sponsor category [6] 292888 0
Individual
Name [6] 292888 0
Nikita Tuli Sood
Address [6] 292888 0
PhD Candidate, University of Melbourne
Murdoch Childrens Research Institute
The Royal Children's Hospital Melbourne
50 Flemington Road Parkville Victoria 3052
Country [6] 292888 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295457 0
Research Ethics & Governance. The Royal Children's Hospital. Melbourne
Ethics committee address [1] 295457 0
Ethics committee country [1] 295457 0
Australia
Date submitted for ethics approval [1] 295457 0
11/07/2016
Approval date [1] 295457 0
04/08/2016
Ethics approval number [1] 295457 0
29099 J

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1124 1124 0 0
/AnzctrAttachments/371072-Amat-c ethic approval.pdf

Contacts
Principal investigator
Name 67346 0
A/Prof Cathy Catroppa
Address 67346 0
Psychologist/Research Fellow
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria, 3052,
Australia
Country 67346 0
Australia
Phone 67346 0
+61 3 99366638
Fax 67346 0
Email 67346 0
cathy.catroppa@mcri.edu.au
Contact person for public queries
Name 67347 0
Edith Botchway
Address 67347 0
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria, 3052,
Australia
Country 67347 0
Australia
Phone 67347 0
+61 416523586
Fax 67347 0
Email 67347 0
edith.botchway@mcri.edu.au
Contact person for scientific queries
Name 67348 0
Cathy Catroppa (A/Prof)
Address 67348 0
Psychologist/Research Fellow
Murdoch Childrens Research Institute
50 Flemington Road
Parkville Victoria, 3052,
Australia
Country 67348 0
Australia
Phone 67348 0
+61 3 99366638
Fax 67348 0
Email 67348 0
cathy.catroppa@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 have no 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.