Evidence map›Paper›PMID 35377882›Full record

Trial reportPloS one2022

A randomized controlled trial of a proportionate universal parenting program delivery model (E-SEE Steps) to enhance child social-emotional wellbeing.

Tracey Bywater, Vashti Berry, Sarah Blower, Matthew Bursnall, Edward Cox, Amanda Mason-Jones, Sinead McGilloway, Kirsty McKendrick, Siobhan Mitchell, Kate Pickett and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Observational
  7. 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

15 authors.

Tracey BywaterDepartment of Health Sciences, University of York, York, North Yorkshire, United Kingdom.ORCID 0000-0001-7207-8753
Vashti BerryCollege of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.
Sarah BlowerDepartment of Health Sciences, University of York, York, North Yorkshire, United Kingdom.
Matthew BursnallSheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom.
Edward CoxCentre for Health Economics, University of York, York, North Yorkshire, United Kingdom.
Amanda Mason-JonesDepartment of Health Sciences, University of York, York, North Yorkshire, United Kingdom.
Sinead McGillowayCentre for Mental Health and Community Research, Maynooth University, Maynooth, Co Kildare, Ireland.
Kirsty McKendrickSheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom.
Siobhan MitchellCollege of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom.
Kate PickettDepartment of Health Sciences, University of York, York, North Yorkshire, United Kingdom.
Gerry RichardsonCentre for Health Economics, University of York, York, North Yorkshire, United Kingdom.
Kiera SolaimanSheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom.
M Dawn TeareInstitute of Health and Society University, Newcastle upon Tyne, Tyne and Wear, United Kingdom.
Simon WalkerCentre for Health Economics, University of York, York, North Yorkshire, United Kingdom.
Karen WhittakerSchool of Nursing, University of Central Lancashire, Preston, Lancashire, United Kingdom.

Funding

Department of Health 13/93/10Department of Health NIHR200166Department of Health NIHR200167
6 · The paper itself

Abstract

backgroundEvidence for parenting programs to improve wellbeing in children under three is inconclusive. We investigated the fidelity, impact, and cost-effectiveness of two parenting programs delivered within a longitudinal proportionate delivery model ('E-SEE Steps').

methodsEligible parents with a child ≤ 8 weeks were recruited into a parallel two-arm, assessor blinded, randomized controlled, community-based, trial with embedded economic and process evaluations. Post-baseline randomization applied a 5:1 (intervention-to-control) ratio, stratified by primary (child social-emotional wellbeing (ASQ:SE-2)) and key secondary (maternal depression (PHQ-9)) outcome scores, sex, and site. All intervention parents received the Incredible Years® Baby Book (IY-B), and were offered the targeted Infant (IY-I)/Toddler (IY-T) program if eligible, based on ASQ:SE-2/PHQ-9 scores. Control families received usual services. Fidelity data were analysed descriptively. Primary analysis applied intention to treat. Effectiveness analysis fitted a marginal model to outcome scores. Cost-effectiveness analysis involved Incremental Cost-Effectiveness Ratios (ICERs).

resultsThe target sample (N = 606) was not achieved; 341 mothers were randomized (285:56), 322 (94%) were retained to study end. Of those eligible for the IY-I (n = 101), and IY-T (n = 101) programs, 51 and 21 respectively, attended. Eight (of 14) groups met the 80% self-reported fidelity criteria. No significant differences between arms were found for adjusted mean difference scores; ASQ:SE-2 (3.02, 95% CI: -0.03, 6.08, p = 0.052), PHQ-9 (-0.61; 95% CI: -1.34, 0.12, p = 0.1). E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control. Serious adverse events (n = 86) were unrelated to the intervention.

conclusionsE-SEE Steps was not effective, but was borderline cost-effective. The model was delivered with varying fidelity, with lower-than-expected IY-T uptake. Changes to delivery systems and the individual programs may be needed prior to future evaluation.

trial registrationInternational Standard Randomized Controlled Trial Number: ISRCTN11079129.

Indexed as

ParentingQuality of LifeCost-Benefit AnalysisFemaleHumansInfantMothersParentsQuality-Adjusted Life Years

Identifiers

PMID35377882
PMCPMC8979462

What OpenQuestion holds

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Registered trials

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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.