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Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol

BACKGROUND: Cognitive behavioural therapy (CBT) is the most widely recognised and efficacious psychological therapy for the treatment of anxiety disorders in children and adults. However, suboptimal remission rates indicate room for improvement in treatments, particularly when both children and thei...

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Autores principales: Galea, Samantha, Salvaris, Chloe A., Yap, Marie B. H., Norton, Peter J., Lawrence, Katherine A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127293/
https://www.ncbi.nlm.nih.gov/pubmed/34001265
http://dx.doi.org/10.1186/s40814-021-00846-8
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author Galea, Samantha
Salvaris, Chloe A.
Yap, Marie B. H.
Norton, Peter J.
Lawrence, Katherine A.
author_facet Galea, Samantha
Salvaris, Chloe A.
Yap, Marie B. H.
Norton, Peter J.
Lawrence, Katherine A.
author_sort Galea, Samantha
collection PubMed
description BACKGROUND: Cognitive behavioural therapy (CBT) is the most widely recognised and efficacious psychological therapy for the treatment of anxiety disorders in children and adults. However, suboptimal remission rates indicate room for improvement in treatments, particularly when both children and their parents have anxiety disorders. Bidirectional transmission and maintenance of anxiety within parent–child dyads could be better targeted by CBT, to improve treatment outcomes for children and parents with anxiety disorders. This study aimed to develop and evaluate the feasibility and acceptability of a concurrent parent–child enhanced CBT intervention that targets the individual’s anxiety disorder(s), as well as the bidirectional factors that influence and maintain anxiety in the dyad. METHODS: Feasibility and acceptability of the proposed CBT protocol will be evaluated in an open-label pilot trial of the intervention utilising qualitative and quantitative data collection. Ten parent–child dyad participants (n = 20) with anxiety disorders will be recruited for the proposed intervention. The intervention is based on an empirically supported 10-week CBT programme for anxiety disorders in adults, adapted to be delivered to parent–child dyads concurrently, and to target anxious modelling and overprotective behaviours through joint observational exposures. Intervention feasibility will be explored by pre-post symptom change on a range of clinician- and self-report measures to determine preliminary indications of participants’ intervention response and effect size calculations to estimate sample size for a future definitive randomised controlled trial (RCT). Additional feasibility measures will include recruitment rates, completion rates, and adherence to programme requirements. To explore participant acceptability of the intervention, qualitative interviews will be conducted with five parent–child dyads who complete the intervention (n = 10), along with five parent–child dyads with anxiety symptoms who express interest in the intervention (n = 10). Acceptability measures will include prospective and retrospective quantitative self-report and qualitative interview data. DISCUSSION: This pilot trial will utilise a mixed-methods design to determine the feasibility and acceptability of delivering an enhanced CBT intervention for the concurrent treatment of parent–child dyads with anxiety disorders. The results of this trial will inform the development and implementation of a future definitive randomised clinical trial to evaluate intervention efficacy. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ANZCTR1261900033410. Prospectively registered: pre-results. Registered 04 March 2019.
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spelling pubmed-81272932021-05-18 Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol Galea, Samantha Salvaris, Chloe A. Yap, Marie B. H. Norton, Peter J. Lawrence, Katherine A. Pilot Feasibility Stud Study Protocol BACKGROUND: Cognitive behavioural therapy (CBT) is the most widely recognised and efficacious psychological therapy for the treatment of anxiety disorders in children and adults. However, suboptimal remission rates indicate room for improvement in treatments, particularly when both children and their parents have anxiety disorders. Bidirectional transmission and maintenance of anxiety within parent–child dyads could be better targeted by CBT, to improve treatment outcomes for children and parents with anxiety disorders. This study aimed to develop and evaluate the feasibility and acceptability of a concurrent parent–child enhanced CBT intervention that targets the individual’s anxiety disorder(s), as well as the bidirectional factors that influence and maintain anxiety in the dyad. METHODS: Feasibility and acceptability of the proposed CBT protocol will be evaluated in an open-label pilot trial of the intervention utilising qualitative and quantitative data collection. Ten parent–child dyad participants (n = 20) with anxiety disorders will be recruited for the proposed intervention. The intervention is based on an empirically supported 10-week CBT programme for anxiety disorders in adults, adapted to be delivered to parent–child dyads concurrently, and to target anxious modelling and overprotective behaviours through joint observational exposures. Intervention feasibility will be explored by pre-post symptom change on a range of clinician- and self-report measures to determine preliminary indications of participants’ intervention response and effect size calculations to estimate sample size for a future definitive randomised controlled trial (RCT). Additional feasibility measures will include recruitment rates, completion rates, and adherence to programme requirements. To explore participant acceptability of the intervention, qualitative interviews will be conducted with five parent–child dyads who complete the intervention (n = 10), along with five parent–child dyads with anxiety symptoms who express interest in the intervention (n = 10). Acceptability measures will include prospective and retrospective quantitative self-report and qualitative interview data. DISCUSSION: This pilot trial will utilise a mixed-methods design to determine the feasibility and acceptability of delivering an enhanced CBT intervention for the concurrent treatment of parent–child dyads with anxiety disorders. The results of this trial will inform the development and implementation of a future definitive randomised clinical trial to evaluate intervention efficacy. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ANZCTR1261900033410. Prospectively registered: pre-results. Registered 04 March 2019. BioMed Central 2021-05-17 /pmc/articles/PMC8127293/ /pubmed/34001265 http://dx.doi.org/10.1186/s40814-021-00846-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Galea, Samantha
Salvaris, Chloe A.
Yap, Marie B. H.
Norton, Peter J.
Lawrence, Katherine A.
Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
title Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
title_full Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
title_fullStr Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
title_full_unstemmed Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
title_short Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
title_sort feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent–child dyads with anxiety disorders: a mixed-methods pilot trial protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127293/
https://www.ncbi.nlm.nih.gov/pubmed/34001265
http://dx.doi.org/10.1186/s40814-021-00846-8
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