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Trial registered on ANZCTR


Registration number
ACTRN12623000392662
Ethics application status
Approved
Date submitted
20/03/2023
Date registered
18/04/2023
Date last updated
9/05/2024
Date data sharing statement initially provided
18/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive behaviour therapy for anxious autistic children: A session-by-session program evaluation
Scientific title
Cognitive behaviour therapy for autistic children: Exploring mechanisms of change in anxiety and social behaviour
Secondary ID [1] 309241 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 329397 0
Anxiety 329398 0
Condition category
Condition code
Mental Health 326341 326341 0 0
Autistic spectrum disorders
Mental Health 326342 326342 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Exploring Feelings' program (Attwood, 2004) will be delivered across six 1.5 hour sessions delivered weekly, with parents and children in separate yet concurrent groups, each with two group leaders. Group leaders will be a paired combination of the lead researcher, and volunteer research assistants pooled from generally registered psychologists and provisional psychologists who are interested in assisting with the Study.

Children will be taught to confront negative cognitions regarding maladaptive emotional judgements through the weekly introduction of new tools or coping strategies, which are added to the ‘Emotional Toolbox’. At the end of each session, children will be provided with ‘project work’ to be completed before the next session. Project work is comprised of tasks that the child is to do outside of sessions that relates the session content, such as collecting ideas from family members or friends about ‘tools’ they use to help manage anxiety, or physically putting together a ‘toolbox’ of items that the child identifies would be helpful to them to manage their anxiety in other settings (e.g., school, home). It is expected that 'project tasks' should take no more than 30 minutes across a week to complete and are to be supported/accompanied by parents where possible. Completion of project work is encouraged but incomplete project work does not preclude children from ongoing participation. Parents will receive psychoeducation about autism and emotion regulation while observing the tools being taught to the children by group leaders. Parents will be encouraged to support their child with project tasks during the parent sessions.

Two additional social skills sessions will be provided at the conclusion of the 'Exploring Feelings' program. These sessions will be of the same duration and frequency (i.e., 1.5 hours each week over two weeks) and will explicitly target asking something to someone, asking to participate, discussing with someone, playing a social game, and saying no. A total of eight sessions are provided overall (i.e., six of the 'Exploring Feelings' program and two social skills sessions).

Adherence to the program will be monitored by weekly attendance reviews and 'check-ins' at the commencement of each session regarding strategies employed over the preceding week. Informal parent feedback will be obtained during parent sessions.

Table 1

Session Overview of the Exploring Feelings Program

Session Number Content of Session and Central Themes

1 Introduction of participants; Being happy; Feeling relaxed; Explanation of the project (things to be happy about, happiness diary, pleasures book, relaxation pictures, cue cards, feeling anxious list). Strengths and talents, Being Happy, Feeling Relaxed.
2 Review main points session 1; Discuss project work; Why we feel anxious; Heroes who become anxious; A time when I have felt anxious; An emotional toolbox to fix the feeling; Session 2 project. Heroes who become anxious, A time when I have felt anxious, An emotional took box (physical tools), An emotional toolbox (relaxation tools)
3 Review main points in session 2; Discuss project work; An emotional toolbox part 2; Session 3 project. Social Tools, Thinking Tools, Other Tools, Inappropriate Tools.
4 Review main points in session 3; Discuss each person’s emotional toolbox and how have been used since last session; Thermometer activity. Practice using the Toolbox.
5 Review main points in session 4; Discuss thermometer’s and review strategies; Social Stories; Antidote to poisonous thoughts; Social story project. Antidote to poisonous thoughts.
6 Review key points from session 5; Discuss each person’s Social Story and antidotes to poisonous thoughts; Sharing Strategies. Sharing Strategies.
7 Social skills I – Conversation skills including asking something to someone, asking to participate, discussing with someone.
8 Social skills II – Playing a social game, saying no.

All participants meeting inclusion criteria for the study (i.e., autistic, aged 6-10 years, Elevated or Clinical Total Anxiety) will be allocated to a treatment group. Three groups will be run each week. Treatment groups will comprise of 5-6 participants and differ only by the day/time of program administration (i.e., three groups running each week but on different days and/or different times). All treatment groups will receive the same program (Exploring Feelings), with all sessions provided in the same order.

The lead researcher is Rachel Pearce. Rachel is a registered psychologist (AHPRA No. PSY0000976955) and Board Certified Behaviour Analyst (BACB CN 1-09-5275) with over 15 years’ experience in clinical practice. Rachel will be responsible for compiling the documentation and resources required for the proposed study (e.g., consent forms, flyers, participant information sheets, intake forms etc etc), identifying the likely participant pool, training research assistants, administering key measures, program delivery, data collection and analysis.

All measures pertaining to study inclusion and outcomes will be administered, scored, and interpreted by the lead researcher. However, assistance will be required to deliver the program outlined and assistance will be obtained by additional registered psychologists currently employed at Caterpillar Clinic, or provisional psychologists currently completing their AHPRA 4+2 internship (meaning they have completed an Honours degree in psychology and are currently completing two-year postgraduate practical training) to obtain registration as a general psychologist if they are willing and able to do this. This is completely voluntary for the registered and provisional psychologists and not a requirement of their employment at the Clinic.

Participants will attend Caterpillar Clinic to complete in-person measures required for the study, which is providing the location for the proposed research. Caterpillar Clinic is a private child psychology practice located in Cairns, Far North Queensland. Each room is furnished in a child- and family-friendly manner. Two rooms will be allocated for QUT participants and sign posted as such during the course of the study. It is likely that the program and parent sessions will be delivered out of the Clinic’s standard office hours (i.e., after 5 p.m. or on Saturdays) so as not to provide any impact to the Clinic’s operations nor confuse research participants with Clinic attendees, and not to interfere with children’s schooling or parent’s work schedules.






Intervention code [1] 325680 0
Treatment: Other
Comparator / control treatment
No control group (within-subjects repeated measures design)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334195 0
Participant's level of anxiety as assessed using the Spence Children's Anxiety Scale (Parent and Child versions) (SCAS-P / SCAS-C)

The SCAS-P is a 38-item measure and the SCAS-C a 44-item measure, both rated on a 4-point Likert-type ranging from 0 (never) to 3 (always).
Timepoint [1] 334195 0
Baseline (intake) and immediate post-intervention (session 8).
Primary outcome [2] 334196 0
Participant's levels of social behaviour using the parent-rated Social Responsiveness Scale 2nd Edition (SRS-2). This scale contains 65 items rated on a 4-point scale from 1 (not true) to 4 (almost always true) by the respondent (parent or legal guardian) based on the child’s behaviour over the past 6 months.
Timepoint [2] 334196 0
Baseline (intake) and immediate post-intervention (session 8)
Primary outcome [3] 334197 0
Participants reports (parent and child) of coping self-efficacy using the Coping Self-Efficacy Scale (CSES), a 26-item measure with each statement rated on a 0-10 point scale (0 being the lowest).
Timepoint [3] 334197 0
Baseline (intake) and immediate post-intervention (session 8).
Secondary outcome [1] 419804 0
Child ratings of session content will be obtained using the Child Outcome Rating Scale (CORS), The scale is comprised of four items measured on a line of least-to-most helpful.
Timepoint [1] 419804 0
Completed at the end of each session (1-8).
Secondary outcome [2] 419805 0
Parent satisfaction with the treatment provided will be measured using the Client Satisfaction Questionnaire (CSQ-8). It comprises of 8 items on a four-point Likert scale, with higher scores indicating higher satisfaction.
Timepoint [2] 419805 0
To be completed by parents at conclusion of treatment (i.e., session 8).
Secondary outcome [3] 419983 0
Additional primary outcome: Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD) Parent and Child versions (ASC-ASD-P and ASC-ASD-C).

The Anxiety Scale for Children- ASD (ASC-ASD©; Rodgers et al., 2016) is a 24 item self-report anxiety questionnaire. Severity is rated on a four-point scale ranging from 0 (never) to 3 (always).
Timepoint [3] 419983 0
Baseline (intake) and at the start of each session across eight sessions for the ASC-ASD-P/C.
Secondary outcome [4] 419984 0
Child ratings of the group program format will be measured with the Child Group Session Rating Scale (CGSRS). This scale comprises of four items measured on a line of least-to-most helpful.
Timepoint [4] 419984 0
The CGSRS will be administered in the final minutes of each session (sessions 1-8).
Secondary outcome [5] 419985 0
Parent ratings of session content will be obtained with the Parent Session Rating Scale (PSRS).This scale is comprised of four items measured on a line of least-to-most helpful.
Timepoint [5] 419985 0
Session ratings will be obtained at the conclusion of each session (sessions 1-8).

Eligibility
Key inclusion criteria
1. Aged between 6 years 0 months and 10 years 11 months; AND
2. Consent provided by parent/legal guardian and assent by child; AND
3. Elevated or Clinical Total anxiety, as determined by the SCAS-P/C; AND
4. Average intelligence (Verbal Comprehension Index (VCI) or Full Scale Intelligence Quotient (FSIQ) score is 85 or higher) as determined by the Weschler Intelligence Scale for Children 5th Edition Australia and New Zealand version (WISC-V A&NZ) at time of intake or during Study one; AND
5. Criteria for autism to be met through parent report and administration of the Autism Diagnostic Observation Schedule Second Edition (ADOS-2) or Social Communication Questionnaire (SCQ: Lifetime Version) at time of intake or during an earlier associated study (i.e., Study one).
Minimum age
6 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inclusion criteria not met; OR
2. Consent not provided by the parent or child; OR
3. Unable to attend in-person for assessment measures or ongoing participation (commit to weekly sessions).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Within-subjects repeated measures design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis indicated that the minimum sample size to yield a statistical power of at least 0.8 with an alpha of 0.05 and a medium effect size (f = 0.5) is 13 (GPower 3.1; Cohen, 1988).

Measurements will be administered at nine timepoints: (Timepoint 0) during administration of pre-intervention assessment measures; (Timepoints 1-8) at the end of each session completed, and after completion of treatment (Timepoint 8). The purpose of the staggered timepoints is to a) evaluate for treatment versus no treatment effects from the first to final timepoint to determine decreases in anxiety occur as anticipated, and b) obtain evaluations of the program immediately post-session to capture information pertinent to each particular session.

To evaluate treatment effects from pre- to post-treatment for each of the outcome measures, a series of repeated measures ANOVAs will be performed on the full data set (i.e., all data combined from all weekly groups). Where significant time effects are found, simple contrasts will be conducted to assess between which time points the significant difference lays (e.g., 1 to 2, 1 to 3, 2 to 5 etc). For condition × time interactions, mean change scores will be used to calculate effect sizes, with effect sizes of 0.2, 0.5, and 0.8 (Cohen, 2013) corresponding to small, medium, and large effect sizes, respectively. Analyses will be performed with SPSS 25.0 (Version 25.0. Armonk, NY: IBM Corp, 2017) software. Statistical tests will be two-tailed with a significance level of p < 0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/04/2023
Actual
29/04/2023
Date of last participant enrolment
Anticipated
30/04/2023
Actual
22/08/2023
Date of last data collection
Anticipated
30/12/2023
Actual
27/12/2023
Sample size
Target
20
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 39860 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 313490 0
Other
Name [1] 313490 0
Caterpillar Clinic
Country [1] 313490 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Faculty of Health
Kelvin Grove Campus
O Block - B Wing - Level 5
Ring Road
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 315199 0
None
Name [1] 315199 0
Address [1] 315199 0
Country [1] 315199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312641 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 312641 0
Queensland University of Technology
Level 4, X Block
Kelvin Grove Campus
Victoria Park Road
Kelvin Grove QLD 4059
Ethics committee country [1] 312641 0
Australia
Date submitted for ethics approval [1] 312641 0
09/05/2022
Approval date [1] 312641 0
14/03/2023
Ethics approval number [1] 312641 0
5435

Summary
Brief summary
The proposed study will deliver an existing validated and empirically supported Cognitive Behaviour Therapy (CBT) program, Exploring Feelings - Anxiety, for anxious young autistic children. The program will be slightly extended based on the results for an earlier study, by way of the inclusion of two additional sessions specifically focused on social skills. A within-subjects design with repeated measures will be used to evaluate changes in levels of anxiety across the delivery of the program. Delivery of pre- and post-intervention assessments along with session-by-session measures will allow the researchers to explore (a) changes in anxiety levels from before to after intervention delivery, and (b) if any changes that do occur are more likely at certain timepoints of the intervention, pointing towards particular components of the intervention as being more helpful than others.
Trial website
Trial related presentations / publications
Public notes
The lead researcher is Rachel Pearce. Rachel completed her Master of Science (Psychology) at the University of Auckland, obtaining First Class Honours in her experimental research on pre-training simple discriminations to facilitate the acquisition of conditional discriminations in an animal population. Since then, Rachel became a registered psychologist (AHPRA No. PSY0000976955) and Board Certified Behaviour Analyst (BACB CN 1-09-5275), now with over 15 years’ experience in clinical practice. She is the founder and Clinical Director of Caterpillar Clinic, a private psychology practice located in Cairns, FNQ, which provides psychological services to typically developing and autistic children aged 2-18 years. She is adept in the administration of diagnostic assessments and screeners for children and parents and has access to diagnostic and physical (e.g., rooms, iPads) resources to be used for the proposed research.

Contacts
Principal investigator
Name 125390 0
Ms Rachel Pearce
Address 125390 0
Caterpillar Clinic Unit 4, 159-161 Aumuller Street, Bungalow QLD 4870
Country 125390 0
Australia
Phone 125390 0
+61 466823598
Fax 125390 0
Email 125390 0
[email protected]
Contact person for public queries
Name 125391 0
Rachel Pearce
Address 125391 0
Caterpillar Clinic Unit 4 159-161 Aumuller Street, Bungalow QLD 4870
Country 125391 0
Australia
Phone 125391 0
+61 466823598
Fax 125391 0
Email 125391 0
[email protected]
Contact person for scientific queries
Name 125392 0
Rachel Pearce
Address 125392 0
Caterpillar Clinic Unit 4, 159-161 Aumuller Street, Bungalow QLD 4870
Country 125392 0
Australia
Phone 125392 0
+61 466823598
Fax 125392 0
Email 125392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Data will be available at the conclusion of the trial (estimated September 2023). As the study involves child-based records, all data will be retained for 15 years and accessible through QUT during that period.
Available to whom?
Only researchers who provide a methodologically sound proposal with consideration made on a case-by-case basis at the discretion of Primary Sponsor (QUT)
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18627Study protocol  [email protected] 385583-(Uploaded-20-03-2023-14-15-41)-Study-related document.docx



Results publications and other study-related documents

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