ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

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]

Baseline, 8-weeks post-randomisation (primary endpoint), and 16-weeks post-randomisation.

Secondary outcome [1]

Responses to uncertainty and low environmental structure (RULES)

Parent-reported questionnaire assessing intolerance of uncertainty in children.

Timepoint [1]