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Trial registered on ANZCTR


Registration number
ACTRN12614001221640
Ethics application status
Approved
Date submitted
31/10/2014
Date registered
19/11/2014
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Date results provided
29/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parent-mediated cognitive behavioural therapy for young children with high-functioning autism spectrum disorder and anxiety: a randomized control trial.
Scientific title
Parent-mediated cognitive behavioural therapy for young children with high-functioning autism spectrum disorder and anxiety: a randomized control trial.
Secondary ID [1] 285299 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asperger's Syndrome/High Functioning Autism 292971 0
Anxiety 292972 0
Condition category
Condition code
Mental Health 293268 293268 0 0
Autistic spectrum disorders
Mental Health 293816 293816 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group based cognitive behavioural therapy. Parents attend 10 x 1.5 hours sessions (over 13 weeks) administered by two provisional psychologists. Groups sizes range from 3 to 7 parents.
Intervention code [1] 290207 0
Behaviour
Intervention code [2] 290627 0
Treatment: Other
Comparator / control treatment
Wait-list control is offered the treatment after 10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 293112 0
Anxiety as measured by scores on the Child Behaviour Checklist.
Timepoint [1] 293112 0
Baseline and at 14 weeks and 26 weeks after intervention commencement. This change was made prior to any enrollments.
Secondary outcome [1] 310372 0
Internalizing and externalizing behaviours as measured by the Child Behaviour Checklist.
Timepoint [1] 310372 0
Baseline and 14 weeks and 26 weeks after intervention commencement.
Secondary outcome [2] 310373 0
Child emotional awareness as measured by an adapted versions of the Emotional Awareness Questionnare
Timepoint [2] 310373 0
Baseline and 14 weeks and 26 weeks after intervention commencement.
Secondary outcome [3] 310374 0
parent depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale 21
Timepoint [3] 310374 0
Baseline and 14 weeks and 26 weeks after intervention commencement.
Secondary outcome [4] 310375 0
parenting stress as measured by the Parenting Stress Index-Short Form
Timepoint [4] 310375 0
Baseline and 14 weeks and 26 weeks after intervention commencement.
Secondary outcome [5] 310376 0
parenting competence as measured by the Parenting Sense of Competence Scale
Timepoint [5] 310376 0
Baseline and 14 weeks and 26 weeks after intervention commencement.

Eligibility
Key inclusion criteria
To be included in the study children must have a diagnosis of 1) Asperger's Syndrome or 2) Autism Spectrum Disorder, requiring support for deficits in social communication and requiring support for restricted, repetitive behaviors, without accompanying intellectual impairment or 3) High Functioning Autism (autism without accompanying intellectual impairment) from a pediatrician or psychologist. Children must also meet the criteria for Asperger's Syndrome/High Functioning Autism according to the Checklist of Autism Spectrum Disorders and have elevated scores on the Preschool Anxiety Scale.
No inclusion criteria applied to parents.
Minimum age
48 Months
Maximum age
83 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who are currently receiving psychological treatment for anxiety will be excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization. Participants were randomly allocated to either treatment condition(TX) or the waitlist control (WLC)via a computer generated, block randomization list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous treatment studies examining the efficacy of modified CBT in treating older children with High Functioning Autism/ Asperger’s Syndrome and anxiety have found large effect sizes for the effect of treatment on anxiety (e.g. Storch et al. 2013). Previous studies on interventions that focus on emotional management in children with ASD have found small to medium effect sizes for the effect of treatment on parent’s mental health and wellbeing (e.g. Scarpa &Reyes, 2011; Whittingham, Sofronoff, Sheffield, & Sanders, 2008). Given that this study is primarily concerned with child outcomes, a large effect size was used to calculate the minimum sample size for the study. As past research has demonstrated the direction of the effect of CBT on anxiety, a one tail analysis was used to calculate sample size. Additionally, as per the convention in clinical psychology an alpha level of .05 was used to calculate sample size. According to the ClinTools Software for Windows (Devilly, 2007) a minimum sample size of 40 participants was needed to produce an effect size of 0.80 with a power of 0.80 (a = 0.05, 1 tailed) for a between groups designed.
A series of preliminary analyses will be conducted to ensure there are no significant differences between treatment and waitlist condition on demographic variables and outcome measures prior to treatment. Chi-square analysis will be conducted to test for significant differences between groups for child gender, child country of birth, mother educational level, father educational level and household income. Univariate analysis of variance (ANOVA) will be used to test for significant differences between groups for child age, mother age, father age and number of siblings. In relation to children’s functioning at pre-treatment ANOVA will be used to test for significant differences between groups on the Preschool Anxiety Scale, Child Behaviour Checklist, Emotional Awareness Questionnaire, Depression, Anxiety and Stress Scale, and Parenting Sense of Competence Scale and Parenting Stress Index.
In order to evaluate effects from pre-post treatment, a series of repeated measures, between groups, 2 (Condition: Treatment, Waitlist Control) x 2 (Time: Pre, Post) ANOVA’s will be conducted for each of the dependent variables separately. Effect sizes for the Condition x Time interaction will be calculated using Hedge’s g and will be based upon the changes scores for each condition’s mean form pre- to post-treatment. Reliable and clinical change will also be computed to evaluate the meaningfulness of change within each condition.
In order to assess for maintenance effects at 3-month follow-up, a series of repeated measures ANOVAS (pre, post, follow-up) will be conducted with the treatment participants only, as the waitlist group cease to be part of the study after post-assessment. The significance of multiple follow up tests will be determined by using Bonferroni adjustments and partial eta squared will be computed to estimate effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2014
Actual
13/05/2014
Date of last participant enrolment
Anticipated
1/06/2015
Actual
16/03/2015
Date of last data collection
Anticipated
Actual
14/09/2015
Sample size
Target
40
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8684 0
4122 - Mount Gravatt

Funding & Sponsors
Funding source category [1] 290177 0
University
Name [1] 290177 0
Griffith University
Country [1] 290177 0
Australia
Primary sponsor type
Individual
Name
Caroline Donovan
Address
Griffith University
School of Psychology
Mt Gravatt Campus
Messines Ridge Road
Mt Gravatt QLD 4122
Country
Australia
Secondary sponsor category [1] 288886 0
None
Name [1] 288886 0
Address [1] 288886 0
Country [1] 288886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291644 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 291644 0
Office for Research
Gold Coast Campus
Room 4.25, The Learning Commons Building (G11)
Griffith University
Parklands Drive, Southport QLD 4215
Ethics committee country [1] 291644 0
Australia
Date submitted for ethics approval [1] 291644 0
Approval date [1] 291644 0
04/12/2013
Ethics approval number [1] 291644 0
PSY/E4/13/HREC

Summary
Brief summary
We are investigating the use of a parent-based Cognitive Behavioural Therapy (CBT) program for treating anxiety difficulties in children aged four to six with Asperger’s Syndrome/High Functioning Autism. Parent-based CBT programs offer an alternative to traditional child-based CBT programs which may be too intellectually demanding for children under the age of seven. Moreover, parent-based CBT programs have be found to effective in treating anxiety in young neuro-typical children and older children with Autism Spectrum Disorders. The design is between groups, repeated measures RCT in which parents will be assigned to one of two conditions: treatment or waitlist control.

It is hypothesized that from pre- to post- treatment children of parents in the CBT group, compared to children of parents in the waitlist control group, will demonstrate a significantly greater improvement in emotional awareness and a significantly greater reduction in anxiety. Additionally, it is hypothesized that from pre- to post- treatment, parents in the CBT group, compared to parents in the waitlist group, will demonstrate a greater reduction in parenting stress and parenting distress as well as a greater improvement in parental self-efficacy and parental satisfaction. Finally, it is hypothesized that pre- to post- treatment improvement for children and parents in the CBT group will be maintained or improved upon at 3-month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51282 0
Dr Caroline Donovan
Address 51282 0
Griffith University
School of Psychology
Mt Gravatt Campus
Messines Ridge Road
Mt Gravatt QLD 4122
Country 51282 0
Australia
Phone 51282 0
+61 07 3735 3401
Fax 51282 0
Email 51282 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 51283 0
Julia Cook
Address 51283 0
Griffith University
School of Psychology
Mt Gravatt Campus
Messines Ridge Road
Mt Gravatt QLD 4122
Country 51283 0
Australia
Phone 51283 0
+61 07 3735 3326
Fax 51283 0
Email 51283 0
julia.cook@griffithuni.edu.au
Contact person for scientific queries
Name 51284 0
Julia Cook
Address 51284 0
Griffith University
School of Psychology
Mt Gravatt Campus
Messines Ridge Road
Mt Gravatt QLD 4122
Country 51284 0
Australia
Phone 51284 0
+61 07 3735 3326
Fax 51284 0
Email 51284 0
c.donovan@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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Cook, J. M., Donovan, C. L., & Garnett, M. S. (201... [More Details]

Documents added automatically
No additional documents have been identified.