Evidence map›Paper›PMID 38233861›Full record

Trial reportTrials2024

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 and 10 more

Open access · goldAbstract readRandomized Controlled TrialPragmatic Clinical TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 13 institutions in 4 countries.

Susan BallNational Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) South West Peninsula (PenARC), Department of Health and Community Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK. s.ball3@exeter.ac.uk.ORCID http://orcid.org/0000-0002-9937-4832
Tessa ReardonDepartments of Experimental Psychology and Psychiatry, University of Oxford, Oxford, UK.
Cathy CreswellDepartments of Experimental Psychology and Psychiatry, University of Oxford, Oxford, UK.
Lucy TaylorDepartments of Experimental Psychology and Psychiatry, University of Oxford, Oxford, UK.
Paul BrownBransgore C of E Primary School, Christchurch, UK.
Tamsin FordUniversity of Cambridge and Cambridge and Peterborough Foundation Trust, Cambridge, UK.
Alastair GrayNuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.
Claire HillSchool of Psychology & Clinical Language Sciences, University of Reading, Reading, UK.
Bec JasperParents and Carers Together, Suffolk, UK.
Michael LarkinLife and Health Sciences, Aston University, Birmingham, UK.
Ian MacdonaldCharlie Waller Trust, Thatcham, UK.
Fran MorganSquare Peg, East Sussex, Eastbourne, UK.
Jack PollardNuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.
Michelle SanchoWest Berkshire Council, Newbury, UK.
Falko F SniehottaNIHR Policy Research Unit Behavioural Science, Newcastle University, Newcastle upon Tyne, UK.
Susan H SpenceSchool of Applied Psychology and Australian Institute of Suicide Research and Prevention, Griffith University, Brisbane, Australia.
Jason StainerStanley Primary School, Strathmore Road, London, UK.
Paul StallardDepartment of Health, University of Bath, Bath, UK.
Mara ViolatoNuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.
Obioha C UkoumunneNational Institute for Health and Care Research (NIHR) Applied Research Collaboration (ARC) South West Peninsula (PenARC), Department of Health and Community Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
University of Oxford · GBOxford Health NHS Foundation Trust · GBUniversity of Exeter · GBAston University · GBEast Sussex County Council · GBGriffith University · AUHeidelberg University · DENational Security Agency · USUniversity of Bath · GBUniversity of Cambridge · GBUniversity of Reading · GBUniversity of Suffolk · GBWiltshire Council · GB

Funding

Programme Grants for Applied Research RP-PG-0218-20010
6 · The paper itself

Abstract

backgroundThe 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

designiCATS-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 registrationClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.

Indexed as

AnxietySchoolsAnxiety DisordersChildFeedbackHumansParentsAnxiety problemsCluster randomised controlled trialEstimandSchool basedScreeningStatistical analysis plan

Identifiers

PMID38233861
PMCPMC10795300
OpenAlexW4390945716

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.