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Trial registered on ANZCTR


Registration number
ACTRN12613001180707
Ethics application status
Approved
Date submitted
25/10/2013
Date registered
28/10/2013
Date last updated
28/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial assessing the effects of an adaptive attention training intervention in children with Intellectual Disabilities.
Scientific title
Developing Educational Learning Tools for Attention (DELTA): A randomised control trial of a novel and adaptive attention training intervention to reduce attention difficulties in 4 to 10 year old children with Intellectual Disabilities.
Secondary ID [1] 283450 0
Nil
Universal Trial Number (UTN)
U1111-1149-5382
Trial acronym
DELTA - Developing Educational Learning Tools for Attention
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention difficulties in children with Intellectual Disabilities 290366 0
Academic difficulties in children with Intellectual Disabilities 290367 0
Executive function difficulties in children with Intellectual Disabilities 290369 0
Behavioural difficulties in children with Intellectual Disabilities 290370 0
Condition category
Condition code
Human Genetics and Inherited Disorders 290756 290756 0 0
Other human genetics and inherited disorders
Mental Health 290757 290757 0 0
Autistic spectrum disorders
Public Health 290758 290758 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a tablet based intervention involving 25 sessions to be taken over a 5 week period. Participants are required to complete 5 sessions per week, these sessions can occur on any day that the participant chooses. However sessions can not occur twice in the same day and a 12 hour lock out from the program will prevent this from occurring. Each session takes approximately 16 minutes, with each game lasting for 4 minutes.
The intervention is based on Posner’s influential theory of attention networks (selection, maintenance and control). The intervention comprises a series of games that target each aspect of the attention network. The games are interactive and adaptive, so that the level of difficulty is automatically increased depending on the child's progress. A reward system will be in place to motivate children and assist with compliance. The intervention automatically logs when the games are played and parents are also asked to make a physical log of the times that the games are played, allowing adherence to be monitored.
Intervention code [1] 288164 0
Prevention
Intervention code [2] 288166 0
Treatment: Other
Comparator / control treatment
An active control group will receive a training program identical to the intervention program except that the games will not target the domain of attention. This training program involves basic motor movements that require minimal attention skills.
Participants will be asked to follow the same training format as the intervention group. That is, a total of 25 session over a period of 5 weeks. Participants are allowed to select 5 days of the week to play the game, and the total session time will be approximately 16 minutes.
Control group
Active

Outcomes
Primary outcome [1] 290754 0
The primary outcome of this trial is positive changes in attention skills and inattentive behaviour.
Attention will be assessed using the Wilding Attention Task which is specifically designed for young children and has been frequently used in individuals with intellectual disabilities.
Additional information regarding attention will be sought from parents (Strengths and Weaknesses of Attention Deficit/Hyperactivity) and teachers (Teachers Scale of Attention in Intellectual Disabilities). Both of these measures are short questionnaires.
Timepoint [1] 290754 0
Assessments occur at three timepoints.

1. Baseline assessment, prior to intervention

2. Post intervention assessment - 5 weeks after intervention commencement

3. Follow Up - 3 months after the post intervention assessment
Secondary outcome [1] 305179 0
Academic skills will be assessed using the Test of Early Mathematics Ability (TEMA), sub scales of the Phonological Abilities Task (PAT; letter knowledge and rhyme detection) and a measure of cardinality (Give a number task).
Timepoint [1] 305179 0
Assessments occur at three timepoints.

1. Baseline assessment, prior to intervention

2. Post intervention assessment - 5 weeks after intervention commencement

3. Follow Up - 3 months after the post intervention assessment
Secondary outcome [2] 305180 0
Executive functions including planning, organisation and working memory will be measured using the Behavioral Rating Inventory of Executive Functions (BRIEF), Automated Working Memory Assessment (AMWA) and the Working Memory Rating Scale (WMRS).
Timepoint [2] 305180 0
Assessments occur at three timepoints.

1. Baseline assessment, prior to intervention

2. Post intervention assessment - 5 weeks after intervention commencement

3. Follow Up - 3 months after the post intervention assessment
Secondary outcome [3] 305181 0
Behaviour will be measured by the Developmental Behaviour Checklist for parents (DBC-P)
Timepoint [3] 305181 0
Assessments occur at three timepoints.

1. Baseline assessment, prior to intervention

2. Post intervention assessment - 5 weeks after intervention commencement

3. Follow Up - 3 months after the post intervention assessment
Secondary outcome [4] 305186 0
Stability of changes in attention difficulties (Wilding attention task(WATT), Strengths and Weaknesses of Attention Deficit/Hyperactivity (SWAN) questionnaire, Teachers Scale of Attention in Intellectual Disabilities questionnaire (TSAID)), executive functions (Behavioral Rating Inventory of Executive Functions (BRIEF), Working Memory Rating Scale (WMRS), Automated Working Memory Assessment (AWMA)), academic skills (Test of Early Mathematics Ability (TEMA), sub scales of the Phonological Abilities Task (PAT), cardinality task), behaviour (Developmental Behaviour Checklist for parents (DBC-P)) and language (Children Communication Checklist (CCC-2)). These will be assessed using the same measures outlined previously in both the baseline and post assessments.
Timepoint [4] 305186 0
Follow Up - 3 months after the post intervention assessment
Secondary outcome [5] 305187 0
Changes in language, will be measured using the Children Communication Checklist (CCC-2)
Timepoint [5] 305187 0
Assessments occur at three timepoints.

1. Baseline assessment, prior to intervention

2. Post intervention assessment - 5 weeks after intervention commencement

3. Follow Up - 3 months after the post intervention assessment

Eligibility
Key inclusion criteria
Participants need to be between the ages of 4 and 10 years when they start the trial.

They must have basic fine motor skills, to allow them to interact with the program.

They must have a diagnosis of Intellectual Disability.

All participants need to have attention difficulties. These attention difficulties will be measured using the Conners 3 parent report questionnaire. Scores above 60 are deemed as elevated and will permit inclusion to the trial.
Minimum age
4 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Motor Impairments
Participants not within the age range, and not attending school
Participants without intellectual disabilities
Participants who do not have attention difficulties.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible families who are willing to take part and have consented will be randomised to one of two training program (attention training or the control training program).
The projects research assistant will provide researchers with an opaque envelope containing either the attention game or the control game, along with the appropriate manual. Both the tablet and manual look identical and make no reference to the domain they are targeting.
This will ensure blinding of group allocations for both parents and the researchers who will carry out the assessments.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This randomisation will occur prior to the baseline session, and will be generated by a biostatistician who is independent of the study. The randomisation will be created variable block sizes and will be stratified by gender, and age to ensure equal allocation of these factors across the 2 interventions. At the time of randomisation participants will be allocated the next available sequential study number in the required strata. This corresponds to an envelope which will contain the allocation to the attention intervention or the control intervention
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Once the 3 month follow up is complete. Families who were randomly assigned to the control intervention will be given access to the attention training intervention for a period of 5 weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Each of these outcome variables will be modelled via random effects regression as a function of occasion of measurement (pre, post, 3 and 6 month follow up), intervention (yes or no), occasion x intervention, age at baseline, gender, and degree of intellectual disability. A power analysis, conservatively assuming intervention and non-intervention groups of 45, based on a simpler (less powerful) repeated measures analysis of variance approach to randomised controlled trials and assuming within person correlations between successive outcome measures of .7 indicates that there will be power above .8 to detect a difference (change) as low as 4 points in the main outcome variable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2013
Actual
Date of last participant enrolment
Anticipated
27/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288168 0
Government body
Name [1] 288168 0
Australian Research Council
Country [1] 288168 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Clayton campus,
Wellington Road
Clayton, Victoria 3800
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 286889 0
None
Name [1] 286889 0
Address [1] 286889 0
Country [1] 286889 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290082 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 290082 0
Ethics committee country [1] 290082 0
Australia
Date submitted for ethics approval [1] 290082 0
21/09/2012
Approval date [1] 290082 0
15/11/2012
Ethics approval number [1] 290082 0
CF12/2779 - 212001505
Ethics committee name [2] 290083 0
Department of Education and Early Childhood Development (DEECD)
Ethics committee address [2] 290083 0
Ethics committee country [2] 290083 0
Australia
Date submitted for ethics approval [2] 290083 0
25/01/2013
Approval date [2] 290083 0
19/03/2013
Ethics approval number [2] 290083 0
2013_001876

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

Contacts
Principal investigator
Name 43834 0
Prof Kim Cornish
Address 43834 0
Head of School,
Level 5, Building 17,
Monash University,
Wellington Road,
Clayton VIC 3800
Country 43834 0
Australia
Phone 43834 0
+61 03 9902 0488
Fax 43834 0
Email 43834 0
kim.cornish@monash.edu
Contact person for public queries
Name 43835 0
Kim Cornish
Address 43835 0
Head of School,
Level 5, Building 17,
Monash University,
Wellington Road,
Clayton VIC 3800
Country 43835 0
Australia
Phone 43835 0
+61 03 9902 0488
Fax 43835 0
Email 43835 0
kim.cornish@monash.edu
Contact person for scientific queries
Name 43836 0
Kim Cornish
Address 43836 0
Head of School,
Level 5, Building 17,
Monash University,
Wellington Road,
Clayton VIC 3800
Country 43836 0
Australia
Phone 43836 0
+61 03 9902 0488
Fax 43836 0
Email 43836 0
kim.cornish@monash.edu

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
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Documents added automatically
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