Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial.
Adaptation, Psychological
Adolescent
Adolescent Behavior
Age Factors
Anxiety
/ diagnosis
Autism Spectrum Disorder
/ diagnosis
Child
Child Behavior
Emotional Regulation
England
Feasibility Studies
Female
Humans
Male
Parenting
Parents
/ psychology
Pilot Projects
Psychotherapy
/ methods
Randomized Controlled Trials as Topic
Single-Blind Method
Time Factors
Treatment Outcome
Uncertainty
Anxiety
Autism
Intervention study
Intolerance of uncertainty
Parent group
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
27 Jun 2019
27 Jun 2019
Historique:
received:
12
12
2018
accepted:
29
05
2019
entrez:
29
6
2019
pubmed:
30
6
2019
medline:
25
2
2020
Statut:
epublish
Résumé
Anxiety is a common diagnosis in children with autism spectrum disorder (ASD). One key mechanism underlying anxiety is intolerance of uncertainty, which is a tendency to react negatively on an emotional, cognitive, and behavioural level to uncertain situations and events. We developed the first intervention programme specifically targeting intolerance of uncertainty in children with ASD: Coping with Uncertainty in Everyday Situations (CUES). CUES is a parent group intervention providing parents of children with ASD with strategies to increase tolerance to uncertainty for their children in everyday situations. The principal aims of the current study are: 1) evaluate the acceptability and feasibility of delivering CUES to parents who have a child with ASD and anxiety; and 2) inform the design of a fully powered trial. This is a feasibility and acceptability single-blind pilot randomised controlled trial comparing CUES (intervention) to a brief psychoeducation, emotional literacy, and relaxation programme (enhanced services as usual). Participants will be assessed at baseline and followed-up immediately post-treatment, and at 12 and 26 weeks post-treatment. Parents who have a child with ASD and anxiety (aged 6-16 years) will be invited to take part in the study and written parental informed consent and child assent will be obtained. Participants will be recruited from the National Health Service mental health teams in the UK. Sixty participants will be randomised to either intervention or enhanced services as usual in a 1:1 ratio. The present study will provide evidence on the acceptability of the CUES intervention to parents and children, and the feasibility of recruitment and delivery to inform the design and sample size for a full-scale randomised controlled trial. Qualitative data will be obtained to understand how feasible CUES is for families, and the experiences of participants regarding their experiences of the intervention. ISRCTN, ISRCTN10139240 . Registered on 14 May 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Anxiety is a common diagnosis in children with autism spectrum disorder (ASD). One key mechanism underlying anxiety is intolerance of uncertainty, which is a tendency to react negatively on an emotional, cognitive, and behavioural level to uncertain situations and events. We developed the first intervention programme specifically targeting intolerance of uncertainty in children with ASD: Coping with Uncertainty in Everyday Situations (CUES). CUES is a parent group intervention providing parents of children with ASD with strategies to increase tolerance to uncertainty for their children in everyday situations. The principal aims of the current study are: 1) evaluate the acceptability and feasibility of delivering CUES to parents who have a child with ASD and anxiety; and 2) inform the design of a fully powered trial.
METHOD
METHODS
This is a feasibility and acceptability single-blind pilot randomised controlled trial comparing CUES (intervention) to a brief psychoeducation, emotional literacy, and relaxation programme (enhanced services as usual). Participants will be assessed at baseline and followed-up immediately post-treatment, and at 12 and 26 weeks post-treatment. Parents who have a child with ASD and anxiety (aged 6-16 years) will be invited to take part in the study and written parental informed consent and child assent will be obtained. Participants will be recruited from the National Health Service mental health teams in the UK. Sixty participants will be randomised to either intervention or enhanced services as usual in a 1:1 ratio.
DISCUSSION
CONCLUSIONS
The present study will provide evidence on the acceptability of the CUES intervention to parents and children, and the feasibility of recruitment and delivery to inform the design and sample size for a full-scale randomised controlled trial. Qualitative data will be obtained to understand how feasible CUES is for families, and the experiences of participants regarding their experiences of the intervention.
TRIAL REGISTRATION
BACKGROUND
ISRCTN, ISRCTN10139240 . Registered on 14 May 2018.
Identifiants
pubmed: 31248435
doi: 10.1186/s13063-019-3479-0
pii: 10.1186/s13063-019-3479-0
pmc: PMC6598241
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
385Subventions
Organisme : Autistica
ID : 7250
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