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Trial registered on ANZCTR


Registration number
ACTRN12615000733572
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
16/07/2015
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Alert Program Study: Determining the effectiveness of a program to improve primary school aged children's measures of self-regulation and executive functioning, with and without a fetal alcohol spectrum disorder, in the Fitzroy Valley region of Western Australia.
Scientific title
Effect of the Alert Program on measures of self-regulation and executive function in primary school aged children in the Fitzroy Valley with fetal alcohol spectrum disorders compared to those without fetal alcohol spectrum disorders
Secondary ID [1] 286987 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-regulation 295444 0
Executive functioning 295514 0
Fetal alcohol spectrum disorders 295515 0
Condition category
Condition code
Neurological 295697 295697 0 0
Studies of the normal brain and nervous system
Neurological 295698 295698 0 0
Other neurological disorders
Mental Health 295778 295778 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Alert Program is a framework designed to support occupational therapist, teachers, parents and other professionals to teach children how to self-regulate by changing their arousal or levels of alertness using sensorimotor strategies. The primary focus is to help children learn to monitor, maintain, and change their levels of alertness so that it is appropriate to a situation or task. The program was initially designed for children aged eight to 12 however it can be adapted for preschool through high school, and for adults. It can be implemented in a variety of settings and the suggested activities can be adapted to meet the needs of the specific client group.

In this study, teachers from nine primary schools will deliver a curriculum version of the Alert Program that has been developed by adapting the commercial resources. Children attending schools in years 1 - 6 in Fitzroy Valley primary schools will by taught 8 Alert Program lessons by their teacher (with the support of the Aboriginal Islander Education Officer or Education Assistant if they have access to one in class). Each lesson will go for approximately 45 minutes to one hour. The curriculum will be delivered over eight weeks in one school term. Schools will make a decision to implement the curriculum (as they can do with any program) however parents will provide consent for their child to participate in data collection.

Teachers will be trained in the Alert Program concepts by attending two six hour training sessions delivered by researchers. The first training session will take place before the intervention commences in the classroom and the second training session between weeks three and four of the intervention. These sessions will include information about the research study, the Alert Program and familiarisation with the curriculum guide and resources provided to teachers. The training will include the viewing of five out of 18 of the original on-line Alert Program leader's training produced by Therapy Works Inc who are the program developers.

All materials and resources required to implement the curriculum will be provided to participating schools. Self-report measures for teacher's adherence to the lesson plans have been included in the curriculum guide. At least 20% of the lessons will be audio recorded and viewed by researchers who will check the lesson delivery against a fidelity checklist.

In addition to the Alert Program lessons being taught in class, a parent workshop will be designed by researchers and delivered to interested family members to learn about the Alert Program concepts and activities they can do at home with their children (who are learning about the program at school).

The sessions will be approximately 90 minutes in duration and delivered at a time negotiated with the school community during the classroom intervention period. The sessions have been designed in consultation with an occupational therapist and the Alert Program trained research team member and community researcher.
Intervention code [1] 292191 0
Behaviour
Comparator / control treatment
The control treatment is regular schooling. The control group will receive the intervention within this cluster randomised control trial (a stepped wedge like study design will be used).

Cluster one will receive the intervention in term two 2016.

The cluster two will act as a control to cluster one in term two 2016 and will receive the intervention in term three of 2016.
Cluster three will act as a control to cluster two in term three of 2016 then receive the intervention in term two 2017.
Cluster four will act as a control to cluster three in term two of 2017 and receive the intervention in term three of 2017.

There is no direct control group for cluster four.
Control group
Active

Outcomes
Primary outcome [1] 295406 0
Changes in student executive functioning assessed by direct testing of students using:*Tower of London task (computerised assessment) * Go no Go task (computerised assessment) * Wisconsin card sorting test (computerised assessment) * Match to sample task (computerised assessment) and * Child occupational self assessment
Timepoint [1] 295406 0
Time point for all instruments: Baseline, within two weeks of the Alert Program curriculum having been delivered and 7-8 weeks after the Alert Program has been delivered
Primary outcome [2] 295525 0
Parental perception of change in their child's executive functioning assessed by parent reports: * Behavior Rating Inventory of Executive Function 2 Screening form - parent version * Eyberg Child Behavior Inventory
Timepoint [2] 295525 0
Time point for all instruments: Baseline, within two weeks of the Alert Program curriculum having been delivered and 7-8 weeks after the Alert Program has been delivered
Primary outcome [3] 295526 0
Teacher perception of change in their students' executive functioning assessed by teacher report: * Behavior Rating Inventory of Executive Function 2 screening form - teacher version * Sutter - Eyberg Student Behavior Inventory - revised
Timepoint [3] 295526 0
Time point for all instruments: Baseline, within two weeks of the Alert Program curriculum having been delivered and 7-8 weeks after the Alert Program has been delivered
Secondary outcome [1] 315527 0
Parent / caregiver satisfaction with the family workshops using structured questionnaire. This questionnaire is being designed specifically for this study.
Timepoint [1] 315527 0
At the conclusion of each family workshop.
Secondary outcome [2] 315885 0
ADDITIONAL PRIMARY OUTCOME: Changes in student self-regulation assessed by direct testing of students using: * Child occupational self assessment ** Tower of London task (computerised assessment) * Go no Go task (computerised assessment) * Wisconsin card sorting test (computerised assessment) * Match to sample task (computerised assessment)
Timepoint [2] 315885 0
Time point for all instruments: Baseline, within two weeks of the Alert Program curriculum having been delivered and 7-8 weeks after the Alert Program has been delivered
Secondary outcome [3] 315886 0
ADDITIONAL PRIMARY OUTCOME: Parental perception of change in their child's self-regulation assessed by parent reports: * Behavior Rating Inventory of Executive Function 2 Screening form - parent version * Eyberg Child Behavior Inventory
Timepoint [3] 315886 0
Time point for all instruments: Baseline, within two weeks of the Alert Program curriculum having been delivered and 7-8 weeks after the Alert Program has been delivered
Secondary outcome [4] 315887 0
ADDITIONAL PRIMARY OUTCOME: Teacher perception of change in their students' self regulation assessed by teacher report: * Behavior Rating Inventory of Executive Function 2 screening form - teacher version * Sutter - Eyberg Student Behavior Inventory - revised
Timepoint [4] 315887 0
Time point for all instruments: Baseline, within two weeks of the Alert Program curriculum having been delivered and 7-8 weeks after the Alert Program has been delivered

Eligibility
Key inclusion criteria
* Children enrolled in years one to six at one of the nine study site schools in the Fitzroy Valley
Minimum age
6 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No children were excluded from the study from the commencement of the enrolment period.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All schools within the Fitzroy Valley region of Western Australia have all agreed in principle to take part in this study. The computer randomisation of schools to clusters was undertaken by Data and Statistics Manager who was not involved in inclusion eligibility decisions.

All eligible students at participating schools will be invited to enrol in the study with consent sought from their parent/caregiver.

As the clustering occurs at the school level with the entire school receiving the program it is not possible to conceal allocation from participants or researchers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each school will be assigned to a cluster using geographical proximity and school enrolment numbers. he timing for each cluster to receive the Alert Program or act as a control will be randomised by computer generated sequence. One cluster will not be randomised because of local considerations. This cluster will receive the intervention last (term three, 2017).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster randomised control trial. This is a variation of the stepped wedge design. There are four geographically stratified clusters. At each time step a new randomly selected cluster is selected to receive the program with an associated control cluster. Clusters which act as controls then receive treatment in the next time step. The final time step has only one treatment group with no control. Testing will occure before and after each time step for each involved cluster with additional follow-up testing undertaken for each treatment cluster.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For quantitative measures the generalized linear mixed model (GLMM) approach will be used as is seems most appropriate for this modified stepped wedge design, can provide weighting for unequal cluster sizes and can estimate effects for other independent variables.

Qualitative data collected via the structured interviews will be analysed using an iterative framework. This framework involves collecting information via interviews or observation, transcribing the collected information and finally reflecting upon the data to determine emergent themes. In this study the researcher will digitally record interviews, which will be transcribed verbatim and then analysed.

Original power calculations were based on a full stepped wedge study design and required 261 children assuming a 10% loss for an RCT with an effect of 30%. As this design has been altered additional power calculations will need to be undertaken by statistical experts. However, all schools within the geographical area have been invited to take part.

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)
WA
Recruitment postcode(s) [1] 9878 0
6765 - Fitzroy Crossing

Funding & Sponsors
Funding source category [1] 291542 0
Government body
Name [1] 291542 0
National Health and Medical Research Council
Address [1] 291542 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country [1] 291542 0
Australia
Funding source category [2] 294157 0
Charities/Societies/Foundations
Name [2] 294157 0
100 Women
Address [2] 294157 0
c/o The Alchemist Foundation Inc.

PO Box 7273

Karawara WA 6152
Country [2] 294157 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 290221 0
Charities/Societies/Foundations
Name [1] 290221 0
Telethon Kids Institute
Address [1] 290221 0
PO Box 855
West Perth WA 6872
Country [1] 290221 0
Australia
Other collaborator category [1] 278505 0
University
Name [1] 278505 0
University of Washington
Address [1] 278505 0
University of Washington
Box 356490
Seattle, WA 98195-6490
Country [1] 278505 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293084 0
University of Western Australia Human Ethics Committee
Ethics committee address [1] 293084 0
M459, 35 Stirling Highway
Crawley WA 6009
Ethics committee country [1] 293084 0
Australia
Date submitted for ethics approval [1] 293084 0
Approval date [1] 293084 0
16/01/2015
Ethics approval number [1] 293084 0
RA/4/1/7234
Ethics committee name [2] 293085 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 293085 0
450 Beaufort Street

Highgate

Western Australia

6003
Ethics committee country [2] 293085 0
Australia
Date submitted for ethics approval [2] 293085 0
Approval date [2] 293085 0
12/03/2015
Ethics approval number [2] 293085 0
601
Ethics committee name [3] 293086 0
Western Australian Country Health Service
Ethics committee address [3] 293086 0
189 Wellington St, Perth WA 6000
Ethics committee country [3] 293086 0
Date submitted for ethics approval [3] 293086 0
Approval date [3] 293086 0
26/06/2015
Ethics approval number [3] 293086 0

Summary
Brief summary
In 2008 local leaders in Fitzroy Valley identified prevention, diagnosis and management of Fetal Alcohol Spectrum Disorders (FASD) and early life trauma (ELT) as a community priority. This led to the development of the Marulu Strategy which aims to address FASD prevention, diagnosis and therapy. Following the results of a prevalence study, Aboriginal community leaders also identified an urgent need for a system-wide and sustainable response to high rates of FASD and neurodevelopmental impairment.
This study will investigate the effectiveness of the Alert Program (registered trademark) at improving primary school aged children’s measures of self-regulation and executive function in the Fitzroy Valley region including those children with FASD.
This study will introduce the Alert Program (registered trademark) to families and community members, into school programs and child health practices in the Fitzroy Valley. The project will document a sustainable and culturally appropriate method of implementing the program through the trial site schools. It is anticipated an approach to screening and therapy for impairments in self-regulation and executive functioning will be translated into other health and educational sites.
Teacher and school support staff will deliver ten Alert Program (registered trademark) lessons in their classrooms over eight weeks using a curriculum and resources provided by the study team. These materials have been developed by adapting existing Alert Program (registered trademark) activities and resources to suit the Kimberley classroom environment. Three workshops will be developed for parents and caregivers so they too can learn about Alert Program(registered trademark) and implement the concepts, activities and vocabulary of the program at home.
Furthermore, this study will contribute to an emerging evidence-base of a multidisciplinary and collaborative model for children in remote and regional areas with FASD, and the development of a sustainable model of health care in the remote Kimberley region. It is also hoped this research will lead to improving the efficiency of health service delivery through utilising telehealth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58398 0
Dr James Fitzpatrick
Address 58398 0
Telethon Kids Institute
PO BOX 855
West Perth WA 6872
Country 58398 0
Australia
Phone 58398 0
+61 403198769
Fax 58398 0
Email 58398 0
james.fitzpatrick@telethonkids.org.au
Contact person for public queries
Name 58399 0
Miss Bree Wagner
Address 58399 0
Telethon Kids Institute
PO BOX 855
West Perth WA 6872
Country 58399 0
Australia
Phone 58399 0
+61 8 94897752
Fax 58399 0
Email 58399 0
bree.wagner@telethonkids.org.au
Contact person for scientific queries
Name 58400 0
Miss Bree Wagner
Address 58400 0
Telethon Kids Institute
PO BOX 855
West Perth WA 6872
Country 58400 0
Australia
Phone 58400 0
+61 8 94897752
Fax 58400 0
Email 58400 0
bree.wagner@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
To be determined by the community partners involved in the study on a case by case basis.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 471 0
Study protocol
Citation [1] 471 0
Link [1] 471 0
Email [1] 471 0
Other [1] 471 0
https://bmjopen.bmj.com/content/8/3/e021462
Attachment [1] 471 0
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