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Trial registered on ANZCTR


Registration number
ACTRN12620001322921
Ethics application status
Approved
Date submitted
7/10/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
“Cool for School”: Can a parent-group help to reduce anxiety in children with autism?
Scientific title
Investigating the effect of a parent-led anxiety intervention on academic outcomes in children with autism
Secondary ID [1] 300205 0
None
Universal Trial Number (UTN)
U1111-1246-1460
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorder 315761 0
Autism Spectrum Disorder 315762 0
Condition category
Condition code
Mental Health 314041 314041 0 0
Anxiety
Mental Health 314042 314042 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an adaptation of Cool Little Kids (CLK); a six-session, parent-led program that has demonstrated excellent outcomes in the reduction of anxiety among preschool-aged children. The core treatment strategy in this program is in vivo exposure, which primarily works via extinction to shift expectations of threat. To better tailor this intervention to children on the autism spectrum, the pre-existing CLK program has been modified to also include processes to help reduce "Intolerance of Uncertainty" which is a construct shown to have a key role in the expression of anxiety among children with autism. The modified CLK program also incorporates examples which describe children on the spectrum to make it more relevant to parents of children on the spectrum.

This modified CLK program is a six-session intervention, delivered face-to-face by a trained member of the research team. The program includes a clinician manual and parent workbook. These documents clearly map out the intervention sessions, providing information on the topics to be discussed and the associated activities. Parents are required to attend all sessions; if they are unable to make a session (due to parent or child illness) they are invited to attend a different session that week, or if they are still unwell all week, are offered a make-up session prior to the next session. Both parents are encouraged to attend if possible. Adherence to the intervention is monitored through checking of attendance and of homework completion. The content of the sessions, each of which lasts 1.75-2 hours with a maximum of 8 parents per session, is as follows:

- Week 1: Welcome to the program; presentation of anxiety in children and how this may differ for children with autism; the different forms of anxiety; discussion of how anxiety presents in the children of the participants; consideration of the factors which contribute to their children’s anxiety; goal setting (what each parent would like their child to be able to do)
- Week 2: How parents can/do deal with anxiety in their children; strategies for reducing anxiety and building bravery
- Week 3: Further strategies for reducing anxiety and how these can be tailored to specific children’s anxiety
- Week 4: Discussion of parents’ experiences of implementing strategies to reduce anxiety; troubleshooting any difficulties they may experience; consideration of the role intolerance of uncertainty plays in maintaining anxiety;
- Week 5: Strategies to increase children’s ability to cope with uncertainty; how to think about parents’ own concerns regarding their child’s anxiety
- Week 6: Considering their child’s progress over the previous 5-weeks; identification of areas that may need further work

During the sessions, parents are encouraged (but not required) to share and reflect on their own experiences of their child’s anxiety and share their homework achievements. Parents will be asked to identify the anxious behaviours or their child, consider how the strategies discussed during the sessions could minimise these behaviours, and practice these techniques at home. They are encouraged to practice the strategies as much as possible, as opportunities arise.

We are piloting this modified program with 4 parents who have provided positive feedback during the sessions. This study aims to further this pilot research by running a larger scale trial of the modified intervention with 64 parents of children with autism: 32 will be allocated to the invention group (thus will complete all four stages of the study; initial assessment, intervention program, short-term follow-up and one-year follow-up) and 32 will be in the control group (therefore only completing the initial, short-term follow-up and one-year follow-up assessments). This method allows for the comparison of anxiety levels between those children whose parents completed the program, and those who did not, thus providing data regarding the efficacy of the program.
Intervention code [1] 316478 0
Treatment: Other
Intervention code [2] 318970 0
Behaviour
Comparator / control treatment
The control group is a "no treatment" control. They will complete the baseline and follow-up assessments, but will not participate in any intervention/treatment as part of this research project.
Control group
Active

Outcomes
Primary outcome [1] 322447 0
The primary outcome is Academic Competence upon starting primary school, which will be completed by teachers as part of this study. As data is collected as part of this study, no data linkage to school records or assessments is required.
Timepoint [1] 322447 0
As children are preschoolers during the time of the intervention, the primary outcome is not measured before or immediately after the intervention. Data on children's academic competence will only be collected at longer-term follow up which will occur one year after the completion of the intervention.
Secondary outcome [1] 378572 0
The secondary outcome is a change in children's anxiety level, as assessed using the Preschool Anxiety Scale Revised (PAS-R) and the Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD).
Timepoint [1] 378572 0
Data on children's anxiety will be collected at three time points: 1) Initial assessment which will occur within four week prior to the start of the intervention; 2) short-term follow up which will occur within two months of the completion of the intervention; and 3) longer-term follow up which will occur one year after the completion of the intervention. Both the short-term follow-up and longer-term follow-up will be used to assess the second outcome.
Secondary outcome [2] 388473 0
Secondary outcome (2) is children's intolerance of uncertainty, as assessed using the Responses to Uncertainty and Low Environmental Structure (RULES) questionnaire.
Timepoint [2] 388473 0
Data on children's intolerance of uncertainty will be collected at three time points: 1) Initial assessment which will occur within four week prior to the start of the intervention; 2) short-term follow up which will occur within two months of the completion of the intervention; and 3) longer-term follow up which will occur one year after the completion of the intervention. Both the short-term follow-up and longer-term follow-up will be used to assess the second outcome.

Eligibility
Key inclusion criteria
Parents will be eligible to participate if their child is aged 4-to-5-years, has a score indicative of autism spectrum on the Autism Diagnostic Observation Schedule-2, and has not yet commenced their first year of formal schooling.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no specific exclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At the time of determining whether a participant was eligible for inclusion, the person making this decision was unaware of group allocation. Group allocation was only determined once participants were deemed eligible for the study. The holder of the group allocation is at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised random number generator.
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
The target sample size was determined though consultation of previous research. Bischof et al. (2018) piloted the original CLK program with children with autism, allocating 13 parents to the intervention group and 13 to the control group. An effect size of .91 was observed on the anxiety measure (Preschool Anxiety Scale-Revised; PAS-R) at two-year follow up. Conservatively assuming a more modest effect (.75) and applying a retention rate of 90% and a significance level of 5%, it is estimated that 64 participants (32 in each group) will be needed to obtain a statistical power of 80% to reject the null hypothesis of no difference. This calculation is based on the t statistic and non-centrality parameter. Under these assumptions, 64 participants will be enrolled.

To determine whether the intervention is able to reduce/prevent anxiety in autism, we will use a series of mixed ANOVAs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2020
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
64
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304635 0
Government body
Name [1] 304635 0
Australian Research Council
Country [1] 304635 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Mount Gravatt Campus
176 Messines Ridge Road
Mount Gravatt
QLD
4122
Country
Australia
Secondary sponsor category [1] 304942 0
Charities/Societies/Foundations
Name [1] 304942 0
AEIOU Foundation
Address [1] 304942 0
Central Office
3 Balaclava St
Woolloongabba
QLD
4102
Country [1] 304942 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305055 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 305055 0
Ethics committee country [1] 305055 0
Australia
Date submitted for ethics approval [1] 305055 0
15/11/2019
Approval date [1] 305055 0
24/12/2019
Ethics approval number [1] 305055 0
2019/989

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

Contacts
Principal investigator
Name 99118 0
A/Prof Dawn Adams
Address 99118 0
Griffith University,
Mount Gravatt Campus,
176 Messines Ridge Road,
Mount Gravatt,
QLD,
4122
Country 99118 0
Australia
Phone 99118 0
+61737355854
Fax 99118 0
Email 99118 0
dawn.adams@griffith.edu.au
Contact person for public queries
Name 99119 0
Dawn Adams
Address 99119 0
Griffith University,
Mount Gravatt Campus,
176 Messines Ridge Road,
Mount Gravatt,
QLD,
4122
Country 99119 0
Australia
Phone 99119 0
+61737355854
Fax 99119 0
Email 99119 0
dawn.adams@griffith.edu.au
Contact person for scientific queries
Name 99120 0
Dawn Adams
Address 99120 0
Griffith University,
Mount Gravatt Campus,
176 Messines Ridge Road,
Mount Gravatt,
QLD,
4122
Country 99120 0
Australia
Phone 99120 0
+61737355854
Fax 99120 0
Email 99120 0
dawn.adams@griffith.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
In line with our ethical approval, all data reported will be amalgamated data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a longitudinal study investigating the role of anxiety on academic outcomes in children on the autism spectrum.2021https://dx.doi.org/10.1371/journal.pone.0257223
N.B. These documents automatically identified may not have been verified by the study sponsor.