Evidence map›Paper›PMID 33024571›Full record

ArticlePilot and feasibility studies2020

The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability.

Elinor Coulman, Richard Hastings, Nick Gore, David Gillespie, Rachel McNamara, Stavros Petrou, Jeremy Segrott, Jill Bradshaw, Kerry Hood, Andrew Jahoda and 5 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 24% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
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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

15 authors at 6 institutions in 1 country.

Elinor CoulmanCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.ORCID 0000-0002-8854-2140
Richard HastingsCentre for Educational Development Appraisal and Research, University of Warwick, Coventry, CV4 7AL UK.
Nick GoreTizard Centre, University of Kent, Cornwallis North East, Canterbury, CT2 7NF UK.
David GillespieCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.
Rachel McNamaraCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.
Stavros PetrouWarwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL UK.
Jeremy SegrottDECIPHer Centre Cardiff University, 1-3 Museum Place, Cardiff, CF10 3BD UK.
Jill BradshawTizard Centre, University of Kent, Cornwallis North East, Canterbury, CT2 7NF UK.
Kerry HoodCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.
Andrew JahodaInstitute of Health and Wellbeing, University of Glasgow, G12 8RZ, Glasgow, UK.
Geoff LindsayCentre for Educational Development Appraisal and Research, University of Warwick, Coventry, CV4 7AL UK.
Fiona Lugg-WidgerCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.
Michael RoblingCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.
Jacqui ShurlockThe Challenging Behaviour Foundation, The Old Courthouse, New Road Avenue, Chatham, Kent, ME4 6BE UK.
Vaso TotsikaDivision of Psychiatry, Faculty of Brain Sciences, University College London, Wing B, Maple House, Tottenham Court Road, London, UK.
Cardiff University · GBUniversity of Warwick · GBUniversity of Kent · GBThe Challenging Behaviour Foundation · GBUniversity College London · GBUniversity of Glasgow · GB

Funding

Department of Health 15/126/11
6 · The paper itself

Abstract

backgroundChildren with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS.

methodsThis study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. DISCUSSION: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field.

trial registrationISRCTN70419473.

Indexed as

Early Positive Approaches to Support (E-PAtS)FeasibilityIntellectual disabilityLearning disabilityMental wellbeingRandomised controlled trialSupport

Identifiers

PMID33024571
PMCPMC7532596
OpenAlexW3091659021

What OpenQuestion holds

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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.