Parent-mediated group-based therapy for young children diagnosed on the autism spectrum with worries about uncertainty or the unknow

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12621000294853
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-17
• Study Completion: 2023-08-16
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Target Intolerance of Uncertainty Situation ratings:<br><br>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). [ Baseline, 8-weeks post-randomisation (primary endpoint), and 16-weeks post-randomisation.]