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Trial registered on ANZCTR


Registration number
ACTRN12621000294853
Ethics application status
Approved
Date submitted
14/01/2021
Date registered
17/03/2021
Date last updated
17/09/2023
Date data sharing statement initially provided
17/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent-mediated group-based therapy for young children diagnosed on the autism spectrum with worries about uncertainty or the unknown
Scientific title
A randomised-controlled trial of a parent-mediated intervention for managing uncertainty in young children diagnosed on the autism spectrum
Secondary ID [1] 303179 0
None
Universal Trial Number (UTN)
U1111-1263-8481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 320307 0
Condition category
Condition code
Mental Health 318228 318228 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention investigated in this trial is a parent-mediated group-based therapy called Coping with Uncertainty in Everyday Situation (CUES©), compared to a waitlist comparator condition.

Therapy will be conducted in small face-to-face groups (6-8 participants (parents/primary caregivers) per group), led by a psychologist (clinical or registered) with experience in delivering group interventions, in 8 2-hour weekly sessions. Intervention sessions will be based at CliniKids, Perth, Western Australia.

The intervention is designed to increase a child’s ability to tolerate uncertainty and develop a more flexible approach to uncertain situations or everyday events. Intervention is parent-mediated; that is, intervention where parents are the primary agent of change for children’s development. The intervention is designed to be delivered by community-based professionals with knowledge and experience of working with children with ASD. A clinical psychologist will run each group with a second facilitator (registered or training psychologist, speech pathologist, or other allied health professional).

Prior to starting the intervention parents are asked to identify a target situation that involves uncertainty through which they will practise the strategies learned with their child. Intervention sessions include understanding the nature of intolerance of uncertainty (IU), different strategies to flexibly manage IU across a variety of settings, and recognising developmental and environmental triggers of IU. Sessions by week include getting to know each other (week 1), understanding uncertainty (week 2), learning about the zone (week 3), practising strategies using visual stories (week 4), practising strategies using play (week 5), using strategies in a real life situation (week 6), conducting an experiment (week 7), reflecting and evaluating (week 8). During each of these sessions, weekly home activities are set for caregivers to complete with their child and consist of completing a one page diary (included with the CUES© manual) to document uncertain situations during the week which cause their child difficulty and their response/strategy to manage this. At the end of the programme, and at follow-up, parents will be asked to evaluate their ability to manage their child's responses to situations of uncertainty in their chosen target situations (primary outcome).

Fidelity to the manualised intervention will be assessed through checking random sessions with a fidelity checklist, completed at the end of the trial.
Intervention code [1] 319488 0
Behaviour
Intervention code [2] 319714 0
Treatment: Other
Comparator / control treatment
The comparator condition is a waitlist condition for two months. After this period, participants will be offered participation in the next available group.
Control group
Active

Outcomes
Primary outcome [1] 326212 0
Change in Target Intolerance of Uncertainty Situation ratings:

Parents will be asked to identify two situations in which the child experiences significant difficulty in tolerating uncertainty, one situation their child would like to do but cannot participate in, and one situation that is necessary to do for their developmental stage. Parents will be asked about the situation, how often it occurs, the child’s reaction (symptoms and intensity), and how it impacts upon the child and/or the family. At baseline, post-intervention, and at follow-up, behavioural examples for each child will be recorded and rated on a nine-point scale of improvement or worsening from baseline (1 = no longer a concern/no distress or impairment, 2 = markedly improved to 8 = markedly worse, 9 = significantly worse).
Timepoint [1] 326212 0
Baseline, 8-weeks post-randomisation (primary endpoint), and 16-weeks post-randomisation.
Secondary outcome [1] 390527 0
Responses to uncertainty and low environmental structure (RULES)

Parent-reported questionnaire assessing intolerance of uncertainty in children.
Timepoint [1] 390527 0
Baseline, 8-weeks post-randomisation, and 16-weeks post-randomisation.
Secondary outcome [2] 390529 0
The Anxiety Scale for Children – Autism Spectrum Disorder Parent version

Parent-reported scale measuring anxiety in children on the autism spectrum with four sub-scales: Separation Anxiety (SA), Uncertainty (U), Performance Anxiety (PA) and Anxious Arousal (AA).
Timepoint [2] 390529 0
Baseline, 8-weeks post-randomisation, and 16-weeks post-randomisation.
Secondary outcome [3] 390530 0
Intolerance of Uncertainty Scale (IUS-12)

This self-report tool assesses parents’ anxious and avoidant components of intolerance of uncertainty,
Timepoint [3] 390530 0
Baseline, 8-weeks post-randomisation, and 16-weeks post-randomisation.
Secondary outcome [4] 390531 0
Parenting Sense of Competence (PSOC)

Questionnaire concerning sense of efficacy and stress in the parenting role
Timepoint [4] 390531 0
Baseline, 8-weeks post-randomisation, and 16-weeks post-randomisation.
Secondary outcome [5] 390532 0
Depression Anxiety and Stress Scales

A self-report screening tool to identify feelings or behaviours related to depression, anxiety and stress.
Timepoint [5] 390532 0
Baseline, 8-weeks post-randomisation, and 16-weeks post-randomisation.

Eligibility
Key inclusion criteria
(a) Parents/caregivers of a child aged between 4 and 7 years of age;
(b) Parents/caregivers of a child diagnosed with an Autism Spectrum Disorder (confirmed with diagnostic documentation);
(c) Parents/caregivers of a child who experiences some anxiety or distress in unfamiliar situations or environments, or routines;
(d) Parents/caregivers who speak and read sufficient English to: (i) understand the requirements of the study to provide informed consent and complete questionnaires, and (ii) participate fully in the therapy sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) The child has a diagnosed complex co-occurring medical or health condition that may preclude full participation in home activities or in implementation of behavioural strategies;
(b) The child has profound intellectual disability that requires significant functional supports;
(c) The family does not intend to remain living in the Perth area for the following 8 months;
(d) Any active court proceedings or special care arrangements (e.g., children in care of the state or situations where there is not a consistent, long-term caregiver) that may impact on participation in the study.
(e) The parent has a serious mental health or other condition that, at the time of the intervention, causes significant distress and or impairment/ impact on parenting and family life, and which would make it difficult for them to access the intervention or to implement the intervention

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)
Screening for eligibility to the trial will be conducted prior to randomisation by the trial coordinator. After informed consent has been provided and eligibility is confirmed, participant ID codes will then be entered into a computer-generated randomisation schedule to determine allocation to intervention or waitlist control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation by a computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Waitlist control. Participants in the control group will be offered the intervention after completion of the waitlist period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
60 parents/caregivers of children on the autism spectrum are planned to be recruited into this trial (30 per condition).

Sample size estimation was based on sample size estimation in a prior feasibility study of CUES in children and adolescents (Rodgers et al., 2019, Trials) and moderate-large effect sizes reported for clinician and parent-reported outcomes of anxiety interventions for young people on the autism spectrum (Perihan et al., 2020, JADD).

For the primary outcome (Target IU Situation ratings), each behaviour is rated on a 9 point scale from improvement to deterioration; top 3 points will constitute a ‘responder’ to intervention, and will be compared to waitlist condition at equivalent post-treatment and follow-up timepoints using a mixed ANOVA design.

Secondary outcomes of child and parent outcomes will be explored using effect estimates and confidence interval estimation using change scores (baseline to post, and to follow-up), controlling for baseline scores, using mixed design ANOVAs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2021
Actual
1/08/2021
Date of last participant enrolment
Anticipated
31/03/2023
Actual
20/02/2023
Date of last data collection
Anticipated
31/08/2023
Actual
16/08/2023
Sample size
Target
60
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 307588 0
Government body
Name [1] 307588 0
Government of WA Department of Health
Country [1] 307588 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Northern Entrance
Perth Children's Hospital
15 Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 308280 0
None
Name [1] 308280 0
Address [1] 308280 0
Country [1] 308280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307643 0
Child and Adolescent Health Service
Ethics committee address [1] 307643 0
Ethics committee country [1] 307643 0
Australia
Date submitted for ethics approval [1] 307643 0
17/08/2020
Approval date [1] 307643 0
27/10/2020
Ethics approval number [1] 307643 0
RGS0000004228

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

Contacts
Principal investigator
Name 107978 0
Dr Gail Alvares
Address 107978 0
CliniKids, Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
Country 107978 0
Australia
Phone 107978 0
+61 08 6319 1698
Fax 107978 0
Email 107978 0
gail.alvares@telethonkids.org.au
Contact person for public queries
Name 107979 0
Gail Alvares
Address 107979 0
CliniKids, Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
Country 107979 0
Australia
Phone 107979 0
+61 08 6319 1698
Fax 107979 0
Email 107979 0
gail.alvares@telethonkids.org.au
Contact person for scientific queries
Name 107980 0
Gail Alvares
Address 107980 0
CliniKids, Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
Country 107980 0
Australia
Phone 107980 0
+61 08 6319 1698
Fax 107980 0
Email 107980 0
gail.alvares@telethonkids.org.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.