Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)

Susan Ball; Tessa Reardon; Cathy Creswell; Lucy Taylor; Paul Brown; Tamsin Ford; Alastair Gray; Claire Hill; Bec Jasper; Michael Larkin; Ian Macdonald; Fran Morgan; Jack Pollard; Michelle Sancho; Falko F. Sniehotta; Susan H. Spence; Jason Stainer; Paul Stallard; Mara Violato; Obioha C. Ukoumunne

doi:10.1186/s13063-023-07898-6

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)

Susan Ball^*, Tessa Reardon, Cathy Creswell, Lucy Taylor, Paul Brown, Tamsin Ford, Alastair Gray, Claire Hill, Bec Jasper, Michael Larkin, Ian Macdonald, Fran Morgan, Jack Pollard, Michelle Sancho, Falko F. Sniehotta, Susan H. Spence, Jason Stainer, Paul Stallard, Mara Violato, Obioha C. Ukoumunne

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — ‘usual school practice’, for children aged 8–9 years in the following: (1) the ‘target population’, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the ‘total population’, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. Methods and design: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. Trial registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022

Original language	English
Article number	62
Number of pages	15
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07898-6
Publication status	Published - 17 Jan 2024

Bibliographical note

Copyright © 2024. The Author(s). This 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 https://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (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.

Keywords

Anxiety problems
Cluster randomised controlled trial
Estimand
School based
Screening
Statistical analysis plan
Humans
Parents
Anxiety/therapy
Anxiety Disorders
Feedback
Child
Schools

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13063_2023_Article_7898.pdf
Copyright © 2024. The Author(s). This 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. The Creative Commons Public Domain Dedication waiver (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.
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Ball, S., Reardon, T., Creswell, C., Taylor, L., Brown, P., Ford, T., Gray, A., Hill, C., Jasper, B., Larkin, M., Macdonald, I., Morgan, F., Pollard, J., Sancho, M., Sniehotta, F. F., Spence, S. H., Stainer, J., Stallard, P., Violato, M., & Ukoumunne, O. C. (2024). Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i). Trials, 25(1), Article 62. https://doi.org/10.1186/s13063-023-07898-6

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title = "Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)",

abstract = "Background: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether {\textquoteleft}screening and intervention{\textquoteright}, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — {\textquoteleft}usual school practice{\textquoteright}, for children aged 8–9 years in the following: (1) the {\textquoteleft}target population{\textquoteright}, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the {\textquoteleft}total population{\textquoteright}, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. Methods and design: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. Trial registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022",

keywords = "Anxiety problems, Cluster randomised controlled trial, Estimand, School based, Screening, Statistical analysis plan, Humans, Parents, Anxiety/therapy, Anxiety Disorders, Feedback, Child, Schools",

author = "Susan Ball and Tessa Reardon and Cathy Creswell and Lucy Taylor and Paul Brown and Tamsin Ford and Alastair Gray and Claire Hill and Bec Jasper and Michael Larkin and Ian Macdonald and Fran Morgan and Jack Pollard and Michelle Sancho and Sniehotta, {Falko F.} and Spence, {Susan H.} and Jason Stainer and Paul Stallard and Mara Violato and Ukoumunne, {Obioha C.}",

note = "Copyright {\textcopyright} 2024. The Author(s). This 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 https://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (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. ",

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day = "17",

doi = "10.1186/s13063-023-07898-6",

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Ball, S, Reardon, T, Creswell, C, Taylor, L, Brown, P, Ford, T, Gray, A, Hill, C, Jasper, B, Larkin, M, Macdonald, I, Morgan, F, Pollard, J, Sancho, M, Sniehotta, FF, Spence, SH, Stainer, J, Stallard, P, Violato, M & Ukoumunne, OC 2024, 'Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)', Trials, vol. 25, no. 1, 62. https://doi.org/10.1186/s13063-023-07898-6

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i). / Ball, Susan; Reardon, Tessa; Creswell, Cathy et al.
In: Trials, Vol. 25, No. 1, 62, 17.01.2024.

Research output: Contribution to journal › Article › peer-review

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AU - Ball, Susan

AU - Reardon, Tessa

AU - Creswell, Cathy

AU - Taylor, Lucy

AU - Brown, Paul

AU - Ford, Tamsin

AU - Gray, Alastair

AU - Hill, Claire

AU - Jasper, Bec

AU - Larkin, Michael

AU - Macdonald, Ian

AU - Morgan, Fran

AU - Pollard, Jack

AU - Sancho, Michelle

AU - Sniehotta, Falko F.

AU - Spence, Susan H.

AU - Stainer, Jason

AU - Stallard, Paul

AU - Violato, Mara

AU - Ukoumunne, Obioha C.

N1 - Copyright © 2024. The Author(s). This 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 https://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (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.

PY - 2024/1/17

Y1 - 2024/1/17

N2 - Background: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — ‘usual school practice’, for children aged 8–9 years in the following: (1) the ‘target population’, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the ‘total population’, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. Methods and design: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. Trial registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022

AB - Background: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — ‘usual school practice’, for children aged 8–9 years in the following: (1) the ‘target population’, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the ‘total population’, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. Methods and design: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. Trial registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022

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KW - Screening

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KW - Parents

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KW - Feedback

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Ball S, Reardon T, Creswell C, Taylor L, Brown P, Ford T et al. Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i). Trials. 2024 Jan 17;25(1):62. doi: 10.1186/s13063-023-07898-6

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)

Abstract

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Keywords

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