ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1246-1460

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety Disorder

Autism Spectrum Disorder

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

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]

Secondary outcome (2) is children's intolerance of uncertainty, as assessed using the Responses to Uncertainty and Low Environmental Structure (RULES) questionnaire.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

11 Lancaster Pl,
Australian Capital Territory,
CANBERRA 2609

Country [1]

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]

Charities/Societies/Foundations

Name [1]

AEIOU Foundation

Address [1]

Central Office
3 Balaclava St
Woolloongabba
QLD
4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Nathan Campus
170 Kessels Rd
Nathan
QLD
4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/11/2019

Approval date [1]

24/12/2019

Ethics approval number [1]

2019/989

Summary

Brief summary

Anxiety disorders affect up to 40% of children on the autism spectrum, with many more showing sub-clinical levels of elevated anxiety. As anxiety can negatively impact many areas of a person’s life, including well-being and academic performance, it is important to develop ways to minimise its occurrence. One such intervention targeting anxiety is the Cool Little Kids group parenting program. Although originally developed for typically developing pre-schoolers, this intervention has shown promise in reducing anxiety in children on the autism spectrum. To better tailor this program for this population, the intervention has been modified to incorporate topics pertinent to anxiety in autism, specifically the intolerance of uncertainty. This study aims to determine the efficacy of this modified Cool Little Kids program on the reduction (or prevention) of anxiety in young children with autism (4- to 5-years-old). It is predicted that parental participation in this program will be associated with a reduction (or prevention) in their child’s anxiety level.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Dawn Adams

Address

Griffith University,
Mount Gravatt Campus,
176 Messines Ridge Road,
Mount Gravatt,
QLD,
4122

Country

Australia

Phone

+61737355854

Fax

[email protected]

Contact person for public queries

Name

A/Prof Dawn Adams

Address

Griffith University,
Mount Gravatt Campus,
176 Messines Ridge Road,
Mount Gravatt,
QLD,
4122

Country

Australia

Phone

+61737355854

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Dawn Adams

Address

Griffith University,
Mount Gravatt Campus,
176 Messines Ridge Road,
Mount Gravatt,
QLD,
4122

Country

Australia

Phone

+61737355854

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Protocol for a longitudinal study investigating the role of anxiety on academic outcomes in children on the autism spectrum.	2021	https://dx.doi.org/10.1371/journal.pone.0257223

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically