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

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          Abstract

          Background

          Evidence 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’).

          Methods

          Eligible 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).

          Results

          The 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.

          Conclusions

          E-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 registration

          International Standard Randomized Controlled Trial Number: ISRCTN11079129.

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          Most cited references31

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          The PHQ-9: validity of a brief depression severity measure.

          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            mice: Multivariate Imputation by Chained Equations inR

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              The Strengths and Difficulties Questionnaire: a research note.

              R. Goodman (1997)
              A novel behavioural screening questionnaire, the Strengths and Difficulties Questionnaire (SDQ), was administered along with Rutter questionnaires to parents and teachers of 403 children drawn from dental and psychiatric clinics. Scores derived from the SDQ and Rutter questionnaires were highly correlated; parent-teacher correlations for the two sets of measures were comparable or favoured the SDQ. The two sets of measures did not differ in their ability to discriminate between psychiatric and dental clinic attenders. These preliminary findings suggest that the SDQ functions as well as the Rutter questionnaires while offering the following additional advantages: a focus on strengths as well as difficulties; better coverage of inattention, peer relationships, and prosocial behaviour; a shorter format; and a single form suitable for both parents and teachers, perhaps thereby increasing parent-teacher correlations.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: MethodologyRole: ResourcesRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: Project administrationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: MethodologyRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: MethodologyRole: ResourcesRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                4 April 2022
                2022
                : 17
                : 4
                Affiliations
                [1 ] Department of Health Sciences, University of York, York, North Yorkshire, United Kingdom
                [2 ] College of Medicine and Health, University of Exeter, Exeter, Devon, United Kingdom
                [3 ] Sheffield Clinical Trials Research Unit, Sheffield, South Yorkshire, United Kingdom
                [4 ] Centre for Health Economics, University of York, York, North Yorkshire, United Kingdom
                [5 ] Centre for Mental Health and Community Research, Maynooth University, Maynooth, Co Kildare, Ireland
                [6 ] Institute of Health and Society University, Newcastle upon Tyne, Tyne and Wear, United Kingdom
                [7 ] School of Nursing, University of Central Lancashire, Preston, Lancashire, United Kingdom
                Illawarra Shoalhaven Local Health District, AUSTRALIA
                Author notes

                Competing Interests: All authors were supported by the grant, National Institute for Health Research (NIHR) Public Health Research (PHR) (ref 13/93/10). TB, SB, KP and GR were also supported by the NIHR Yorkshire and Humber Applied Research Collaboration (ARC-YH; Ref: NIHR200166, see https://www.arc-yh.nihr.ac.uk,); VB by the South West Peninsula ARC (PenARC, Ref: NIHR200167, see https://arc-swp.nihr.ac.uk). Public Health England supported research sites’ excess treatment costs (no award number). This above funding does not alter our adherence to PLOS ONE policies on sharing data and materials. In addition, TB is a voluntary Trustee for Children’s Early Intervention Trust (CEIT). Early Intervention Wales Training (EIWT) is owned by CEIT and offers training courses, including Incredible Years ® (IY). Trustees do not benefit financially from trainings or CEIT/EIWT activities. ESEE study trainings were arranged via the IY developer in the U.S., not via EIWT.

                Article
                PONE-D-21-24712
                10.1371/journal.pone.0265200
                8979462
                35377882
                77a5afaf-d930-4c13-997d-281c1c65d956
                © 2022 Bywater et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 1, Tables: 3, Pages: 17
                Product
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100001921, Public Health Research Programme;
                Award ID: 13/93/10
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;
                Award ID: ARC-YH NIHR200166
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;
                Award ID: PenARC NIHR200167
                Award Recipient :
                Funded by: Public Health England
                Award Recipient :
                The authors confirm the independence of researchers from funders and that all authors had full access to the study data (including statistical reports and tables) and take responsibility for the integrity of the data and the accuracy of the analysis. All authors were supported by the grant, National Institute for Health Research (NIHR) Public Health Research (PHR) (ref 13/93/10) (see https://fundingawards.nihr.ac.uk/award/13/93/10). TB, SB, KP and GR are also supported by the NIHR Yorkshire and Humber Applied Research Collaboration (ARC-YH; Ref: NIHR200166, see https://www.arc-yh.nihr.ac.uk,); VB by the South West Peninsula ARC (PenARC, Ref: NIHR200167, see https://arc-swp.nihr.ac.uk). The study sponsor (University of York), and funders (with additional support from Public Health England for site’s excess treatment costs (no award number), see https://www.gov.uk/government/organisations/public-health-england/about), were not involved in the study design; data collection, analysis, and interpretation; in the writing of the report; or in the decision to submit the article for publication. The views in this publication are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
                Categories
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                Age Groups
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                People and Places
                Population Groupings
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                Social Sciences
                Economics
                Economic Analysis
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                Custom metadata
                The E-SEE data sharing plan follows a controlled access model as described in Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials. Anonymised data are available upon request via the ‘Research Data York’ data repository: https://doi.org/10.15124/41fd35ba-bd9c-4c2f-bb50-c8c92b8661ee. To request access to this dataset please email Research Data York repository at lib-open-research@ 123456york.ac.uk . Sharing of this quantitative data set will be subject to the completion of a data access request form and, if approved, subject to a data sharing agreement, due to: a) Data containing potentially sensitive participant information such as mental health and domestic violence. b) Ethical concerns around using the data in a way that is not consistent with the PIS, e.g. for research that does not have ethical approval. Data requests will be reviewed by a data access committee, which will include members of the trial management team and independent members from ARC-YH Best Start Steering Committee. A data sharing agreement will be required to ensure data is used in accordance with the trial funder, and ethical guidelines.

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