Development and Evaluation of the CASTLE Trial Online Sleep Intervention for Parents of Children with Epilepsy

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Abstract

Introduction: Many of the sleep problems experienced by children with epilepsy (CWE) have the same behavioural basis as common sleep problems seen in typically developing (TD) children. Behavioural sleep interventions (BSIs) are widely used to treat these sleep problems in TD children and are hypothesised to be effective for CWE. However, specific considerations need to be addressed and incorporated into a BSI for CWE to ensure the intervention is tailored to this population's needs. This paper details developing and tailoring an online BSI for parents of CWE, to be used in the CASTLE (Changing Agendas on Sleep, Treatment and Learning in Epilepsy) Sleep-E clinical trial.

Method: In phase one, two existing theory-driven paediatric BSIs were adapted into a novel online behavioural sleep intervention (CASTLE Online Sleep Intervention or COSI) which specifically incorporated the needs and requirements reported by nine parents of CWE. Scoping their needs included conducting interviews with three CWE so that they could contribute to the overall intervention content. In phase two, six of these parents evaluated COSI, reviewing and feeding back on COSI until parental approval for content and functionality was achieved.

Results: In phase one, a range of adaptations was made to the content and presentation of standardised intervention material to acknowledge and emphasise the key seizure-specific issues to ensure COSI best met parents of CWE's needs. Adaptations included embedding parent and child experiences in the intervention, including particular information requested by parents, such as the links between sleep and seizures and managing child and parental anxieties around sleep, as well as developing functionality to personalise the delivery of content. In phase two, parents confirmed that they found the final version of COSI to be functional and appropriate (after one round of review) for use by parents of CWE and that 100% would recommend it to other families who have CWE.

Discussion: It is hoped that the use of evidence-based BSIs, adapted to consider salient epilepsy-specific factors, will increase parent-engagement, COSI's relevance for this particular patient group and overall efficacy in improving sleep in CWE. The effectiveness of COSI will be tested in the CASTLE Sleep-E clinical trial ( https://castlestudy.org.uk/).

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Most cited references 37

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Patient and family engagement offers a promising pathway toward better-quality health care, more-efficient care, and improved population health. Since definitions of patient engagement and conceptions of how it works vary, we propose a framework. We first present the forms engagement can take, ranging from consultation to partnership. We discuss the levels at which patient engagement can occur across the health care system, from the direct care setting to incorporating patient engagement into organizational design, governance, and policy making. We also discuss the factors that influence whether and to what extent engagement occurs. We explore the implications of our multidimensional framework for the development of interventions and policies that support patient and family engagement, and we offer a research agenda to investigate how such engagement leads to improved outcomes.

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A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy.

Susan Michie, Stefanie Ashford, Stephan Dombrowski … (2011)

Current reporting of intervention content in published research articles and protocols is generally poor, with great diversity of terminology, resulting in low replicability. This study aimed to extend the scope and improve the reliability of a 26-item taxonomy of behaviour change techniques developed by Abraham and Michie [Abraham, C. and Michie, S. (2008). A taxonomy of behaviour change techniques used in interventions. Health Psychology, 27(3), 379-387.] in order to optimise the reporting and scientific study of behaviour change interventions. Three UK study centres collaborated in applying this existing taxonomy to two systematic reviews of interventions to increase physical activity and healthy eating. The taxonomy was refined in iterative steps of (1) coding intervention descriptions, and assessing inter-rater reliability, (2) identifying gaps and problems across study centres and (3) refining the labels and definitions based on consensus discussions. Labels and definitions were improved for all techniques, conceptual overlap between categories was resolved, some categories were split and 14 techniques were added, resulting in a 40-item taxonomy. Inter-rater reliability, assessed on 50 published intervention descriptions, was good (kappa = 0.79). This taxonomy can be used to improve the specification of interventions in published reports, thus improving replication, implementation and evidence syntheses. This will strengthen the scientific study of behaviour change and intervention development.

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A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application.

Janice G Douglas, S Kyle, Colin Espie … (2012)

The internet provides a pervasive milieu for healthcare delivery. The purpose of this study was to determine the effectiveness of a novel web-based cognitive behavioral therapy (CBT) course delivered by an automated virtual therapist, when compared with a credible placebo; an approach required because web products may be intrinsically engaging, and vulnerable to placebo response. Randomized, placebo-controlled trial comprising 3 arms: CBT, imagery relief therapy (IRT: placebo), treatment as usual (TAU). Online community of participants in the UK. One hundred sixty-four adults (120 F: [mean age 49y (18-78y)] meeting proposed DSM-5 criteria for Insomnia Disorder, randomly assigned to CBT (n = 55; 40 F), IRT placebo (n = 55; 42 F) or TAU (n = 54; 38 F). CBT and IRT each comprised 6 online sessions delivered by an animated personal therapist, with automated web and email support. Participants also had access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users had access to a moderated social network/community of users. TAU comprised no restrictions on usual care and access to an online sleep diary. Major assessments at baseline, post-treatment, and at follow-up 8-weeks post-treatment; outcomes appraised by online sleep diaries and clinical status. On the primary endpoint of sleep efficiency (SE; total time asleep expressed as a percentage of the total time spent in bed), online CBT was associated with sustained improvement at post-treatment (+20%) relative to both TAU (+6%; d = 0.95) and IRT (+6%: d = 1.06), and at 8 weeks (+20%) relative to IRT (+7%: d = 1.00) and TAU (+9%: d = 0.69) These findings were mirrored across a range of sleep diary measures. Clinical benefits of CBT were evidenced by modest superiority over placebo on daytime outcomes (d = 0.23-0.37) and by substantial improved sleep-wake functioning on the Sleep Condition Indicator (range of d = 0.77-1.20). Three-quarters of CBT participants (76% [CBT] vs. 29% [IRT] and 18% [TAU]) completed treatment with SE > 80%, more than half (55% [CBT] vs. 17% [IRT] and 8% [TAU]) with SE > 85%, and over one-third (38% [CBT] vs. 6% [IRT] and 0% [TAU]) with SE > 90%; these improvements were largely maintained during follow-up. CBT delivered using a media-rich web application with automated support and a community forum is effective in improving the sleep and associated daytime functioning of adults with insomnia disorder. ISRCTN - 44615689.

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Author and article information

Contributors

Luci Wiggs: URI : http://loop.frontiersin.org/people/312482/overview

Georgia Cook: URI : http://loop.frontiersin.org/people/1138054/overview

Harriet Hiscock: URI : http://loop.frontiersin.org/people/744914/overview

Deb K. Pal: URI : http://loop.frontiersin.org/people/233112/overview

Paul Gringras: URI : http://loop.frontiersin.org/people/232684/overview

Journal

Journal ID (nlm-ta): Front Psychol

Journal ID (iso-abbrev): Front Psychol

Journal ID (publisher-id): Front. Psychol.

Title: Frontiers in Psychology

Publisher: Frontiers Media S.A.

ISSN (Electronic): 1664-1078

Publication date (Electronic): 02 July 2021

Publication date Collection: 2021

Volume: 12

Electronic Location Identifier: 679804

Affiliations

[1] ¹Centre for Psychological Research, Department of Psychology, Health and Professional Development, Faculty of Health and Life Sciences, Oxford Brookes University , Oxford, United Kingdom

[2] ²Health Services Research Unit, Royal Children's Hospital , Melbourne, VIC, Australia

[3] ³Centre for Community Child Health, Murdoch Children's Research Institute , Melbourne, VIC, Australia

[4] ⁴Department of Paediatrics, The University of Melbourne , Melbourne, VIC, Australia

[5] ⁵Department of Paediatric Neuroscience, Evelina London Children's Hospital , London, United Kingdom

[6] ⁶Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London , London, United Kingdom

[7] ⁷Medical Research Council Centre for Neurodevelopmental Disorders, King's College London , London, United Kingdom

[8] ⁸Department of Paediatric Neuroscience, King's College Hospital , London, United Kingdom

[9] ⁹Children's Sleep Medicine, Evelina London Children's Hospital , London, United Kingdom

[10] ¹⁰Women and Children's Institute, King's College London , London, United Kingdom

Author notes

Edited by: Christian Franceschini, University of Parma, Italy

Reviewed by: Elizabeth Halstead, University College London, United Kingdom; Sejal V. Jain, University of Arizona, United States

*Correspondence: Luci Wiggs lwiggs@ 123456brookes.ac.uk

This article was submitted to Psychology for Clinical Settings, a section of the journal Frontiers in Psychology

Article

DOI: 10.3389/fpsyg.2021.679804

PMC ID: 8283529

PubMed ID: 34276499

SO-VID: 2ef25907-a3cc-4108-9e81-6d2379f8830e

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 12 March 2021

Date accepted : 17 May 2021

Page count

Figures: 7, Tables: 3, Equations: 0, References: 40, Pages: 13, Words: 10331

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Development and Evaluation of the CASTLE Trial Online Sleep Intervention for Parents of Children with Epilepsy

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Most cited references 37

Patient and family engagement: a framework for understanding the elements and developing interventions and policies.

A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy.

A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application.

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