Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Autism Spectrum Disorder | Study protocol

Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial

Authors: Jacqui Rodgers, Jane Goodwin, Jeremy R. Parr, Victoria Grahame, Catharine Wright, John Padget, Deborah Garland, Malcolm Osborne, Marie Labus, Ashleigh Kernohan, Mark Freeston

Published in: Trials | Issue 1/2019

Login to get access

Abstract

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

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

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

ISRCTN, ISRCTN10139240. Registered on 14 May 2018.
Appendix
Available only for authorised users
Literature
1.
Autistica. Your questions: shaping future autism research. London: Autistica; 2016.
2.
van Steensel FJA, Bögels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011;14(3):302.PubMedPubMedCentralCrossRef
3.
Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008;47(8):921–9.PubMedCrossRef
4.
Hill RM, Castellanos D, Pettit JW. Suicide-related behaviors and anxiety in children and adolescents: a review. Clin Psychol Rev. 2011;31(7):1133–44.PubMedCrossRef
5.
Rodgers J, Hodgson A, Shields K, Wright C, Honey E, Freeston M. Towards a treatment for intolerance of uncertainty in young people with autism spectrum disorder: development of the Coping with Uncertainty in Everyday Situations (CUES©) programme. J Autism Dev Disord. 2017;47(12):3959–66.PubMedCrossRef
6.
Kerns CM, Kendall PC, Berry L, Souders MC, Franklin ME, Schultz RT, et al. Traditional and atypical presentations of anxiety in youth with autism spectrum disorder. J Autism Dev Disord. 2014;44(11):2851–61.PubMedPubMedCentralCrossRef
7.
Carleton RN, Mulvogue MK, Thibodeau MA, McCabe RE, Antony MM, Asmundson GJG. Increasingly certain about uncertainty: intolerance of uncertainty across anxiety and depression. J Anxiety Disord. 2012;26(3):468–79.PubMedCrossRef
8.
Buhr K, Dugas MJ. The role of fear of anxiety and intolerance of uncertainty in worry: an experimental manipulation. Behav Res Ther. 2009;47(3):215–23.PubMedCrossRef
9.
Keefer A, Kreiser NL, Singh V, Blakeley-Smith A, Duncan A, Johnson C, et al. Intolerance of uncertainty predicts anxiety outcomes following CBT in youth with ASD. J Autism Dev Disord. 2017;47(12):3949–58.PubMedCrossRef
10.
Wigham S, Rodgers J, South M, McConachie H, Freeston M. The interplay between sensory processing abnormalities, intolerance of uncertainty, anxiety and restricted and repetitive behaviours in autism spectrum disorder. J Autism Dev Disord. 2015;45(4):943–52.PubMedCrossRef
11.
Boulter C, Freeston M, South M, Rodgers J. Intolerance of uncertainty as a framework for understanding anxiety in children and adolescents with autism spectrum disorders. J Autism Dev Disord. 2014;44(6):1391–402.PubMedCrossRef
12.
Chamberlain PD, Rodgers J, Crowley MJ, White SE, Freeston MH, South M. A potentiated startle study of uncertainty and contextual anxiety in adolescents diagnosed with autism spectrum disorder. Mol Autism. 2013;4(1):31.PubMedPubMedCentralCrossRef
13.
Maisel ME, Stephenson KG, South M, Rodgers J, Freeston MH, Gaigg SB. Modeling the cognitive mechanisms linking autism symptoms and anxiety in adults. J Abnorm Psychol. 2016;125(5):692–703.PubMedCrossRef
14.
Boswell JF, Thompson-Hollands J, Farchione TJ, Barlow DH. Intolerance of uncertainty: a common factor in the treatment of emotional disorders. J Clin Psychol. 2013;69(6):630–45.PubMedCrossRef
15.
Wild A, Freeston M, Heary S, Rodgers J. Diminished physiological flexibility is associated with intolerance of uncertainty during affective decision making in adolescence. J Exp Psychopathol. 2014;5(4):503–13.CrossRef
16.
Perrin S, editor A randomized controlled trial of cognitive therapy for generalized anxiety disorder in youth: the role of intolerance of uncertainty in symptom change. British Association of Behavioural and Cognitive Therapy (BABCP) annual meeting; 2014.
17.
Laugesen N, Dugas MJ, Bukowski WM. Understanding adolescent worry: the application of a cognitive model. J Abnorm Child Psychol. 2003;31(1):55–64.PubMedCrossRef
18.
Kertz S, Woodruff-Borden J. The role of metacognition, intolerance of uncertainty, and negative problem orientation in children’s worry. Behav Cogn Psychother. 2013;41(2):243–8.PubMedCrossRef
19.
Fialko L, Bolton D, Perrin S. Applicability of a cognitive model of worry to children and adolescents. Behav Res Ther. 2012;50(5):341–9.PubMedCrossRef
20.
Wilkinson A, Meares K, Freeston M. CBT for worry and generalised anxiety disorder. London: Sage Publications Ltd; 2011.CrossRef
21.
Hebert EA, Dugas MJ. Behavioral experiments for intolerance of uncertainty: challenging the unknown in the treatment of generalized anxiety disorder. Cogn Behav Pract. 2019;26(2):421–36.CrossRef
22.
Payne S, Bolton D, Perrin S. A pilot investigation of cognitive therapy for generalized anxiety disorder in children aged 7–17 years. Cogn Ther Res. 2011;35(2):171–8.CrossRef
23.
Leger E, Ladouceur R, Dugas MJ, Freeston MH. Cognitive-behavioral treatment of generalized anxiety disorder among adolescents: a case series. J Am Acad Child Adolesc Psychiatry. 2003;42(3):327–30.PubMedCrossRef
24.
Ladouceur R, Dugas MJ, Freeston MH, Leger E, Gagnon F, Thibodeau N. Efficacy of a cognitive-behavioral treatment for generalized anxiety disorder: evaluation in a controlled clinical trial. J Consult Clin Psychol. 2000;68(6):957–64.PubMedCrossRef
25.
Dugas MJ, Ladouceur R. Treatment of GAD. Targeting intolerance of uncertainty in two types of worry. Behav Modif. 2000;24(5):635–57.PubMedCrossRef
26.
27.
Joyce C, Honey E, Leekam SR, Barrett SL, Rodgers J. Anxiety, intolerance of uncertainty and restricted and repetitive behaviour: insights directly from young people with ASD. J Autism Dev Disord. 2017;47(12):3789–802.PubMedCrossRef
28.
Rodgers J, Glod M, Connolly B, McConachie H. The relationship between anxiety and repetitive behaviours in autism spectrum disorder. J Autism Dev Disord. 2012;42(11):2404–9.PubMedCrossRef
29.
Kanner L. Autistic disturbances of affective contact. Nerv Child. 1943;2:217–50.
30.
Rodgers J, Wigham S, Gray L, Honey E, Freeston M, South M. Making sense of repetitive behaviours in autism spectrum disorder: the relevance of intolerance of uncertainty. San Sebastian: International Meeting for Autism Research; 2013.
31.
Rodgers J, Wigham S, McConachie H, Freeston M, Honey E, Parr JR. Development of the anxiety scale for children with autism spectrum disorder (ASC-ASD). Autism Res. 2016;9(11):1205–15.PubMedCrossRef
32.
Hodgson AR, Freeston MH, Honey E, Rodgers J. Facing the unknown: intolerance of uncertainty in children with autism spectrum disorder. J Appl Res Intellect Disabil. 2017;30(2):336–44.PubMedCrossRef
33.
Neil L, Olsson NC, Pellicano E. The relationship between intolerance of uncertainty, sensory sensitivities, and anxiety in autistic and typically developing children. J Autism Dev Disord. 2016;46(6):1962–73.PubMedPubMedCentralCrossRef
34.
Kerns CM, Rump K, Worley J, Kratz H, McVey A, Herrington J, et al. The differential diagnosis of anxiety disorders in cognitively-able youth with autism. Cogn Behav Pract. 2016;23(4):530–47.CrossRef
35.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.PubMedCrossRef
36.
Rutter M, Bailey A, Lord C. The social communication questionnaire manual. Los Angeles: Western Psychological Services; 2003.
37.
Sparrow SS, Cicchetti DV, Saulnier CA. Vineland adaptive behavior scales third ed. San Antonio: Pearson; 2016.
38.
Kerns CM, Silverman WK, Albano AM. Anxiety disorders interview schedule for autism spectrum and developmental disorders: child version: Oxford University Press. In press
39.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.PubMedCrossRef
40.
Arnold LE, Vitiello B, McDougle C, Scahill L, Shah B, Gonzalez NM, et al. Parent-defined target symptoms respond to risperidone in RUPP autism study: customer approach to clinical trials. J Am Acad Child Adolesc Psychiatry. 2003;42(12):1443–50.PubMedCrossRef
41.
Grahame V, Brett D, Dixon L, McConachie H, Lowry J, Rodgers J, et al. Managing repetitive behaviours in young children with autism spectrum disorder (ASD): pilot randomised controlled trial of a new parent group intervention. J Autism Dev Disord. 2015;45(10):3168–82.PubMedCrossRef
42.
Maskey M, Lowry J, Rodgers J, McConachie H, Parr JR. Reducing specific phobia/fear in young people with autism spectrum disorders (ASDs) through a virtual reality environment intervention. PLoS One. 2014;9(7):e100374.PubMedPubMedCentralCrossRef
43.
Walker S. What do we know about the relationship between intolerance of uncertainty and worry in young children? Newcastle University; 2009.
44.
Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, et al. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997;36(4):545–53.PubMedCrossRef
45.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995;33(3):335–43.PubMedCrossRef
46.
King G, Law M, King S, Hurley P, Hanna S, Kertoy M, et al. Children’s Assessment of Participation and Enjoyment (CAPE) and Preferences for Activities of Children (PAC). San Antonio: Harcourt Assessment, Inc; 2004.
47.
Sofronoff K, Farbotko M. The effectiveness of parent management training to increase self-efficacy in parents of children with Asperger syndrome. Autism. 2002;6(3):271–86.PubMedCrossRef
48.
Sydes MR, Spiegelhalter DJ, Altman DG, Babiker AB, Parmar MK. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials. 2004;1(1):60–79.PubMedCrossRef
49.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef
Metadata
Title
Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial
Authors
Jacqui Rodgers
Jane Goodwin
Jeremy R. Parr
Victoria Grahame
Catharine Wright
John Padget
Deborah Garland
Malcolm Osborne
Marie Labus
Ashleigh Kernohan
Mark Freeston
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3479-0

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial

Research

Regional cerebral oxygen saturation and postoperative delirium in endovascular surgery: a prospective cohort study

Study protocol

Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): study protocol for a cluster randomised controlled trial of a community-based smoke-free homes intervention, with or without Indoor Air Quality feedback

Research

Leucine-enriched essential amino acid supplementation in mechanically ventilated trauma patients: a feasibility study

Editorial

Protocols—more structure, less ‘Wuthering Heights’

Study protocol

A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY)