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      Joint observation in NICU (JOIN): A randomized controlled trial testing an early, one-session intervention during preterm care to improve perceived maternal self-efficacy and other mental health outcomes

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          Abstract

          Background

          Parents of preterm infants in the Neonatal Intensive Care Unit (NICU) environment may experience psychological distress, decreased perceived self-efficacy, and/or difficulties in establishing an adaptive parent-infant relationship. Early developmental care interventions to support the parental role and infant development are essential and their impact can be assessed by an improvement of parental self-efficacy perception. The aims were to assess the effects of an early intervention provided in the NICU (the Joint Observation) on maternal perceived self-efficacy compared to controls (primary outcome) and to compare maternal mental health measures (perceived stress, anxiety, and depression), perception of the parent-infant relationship, and maternal responsiveness (secondary outcomes).

          Methods

          This study was a monocentric randomized controlled trial registered in clinicatrials.gov (NCT02736136), which aimed at testing a behavioural intervention compared with treatment-as-usual. Mothers of preterm neonates born 28 to 32 6/7 weeks gestation were randomly allocated to either the intervention or the control groups. Outcome measures consisted of self-report questionnaires completed by the mothers at 1 and 6 months after enrollment and assessing perceived self-efficacy, mental health, perception of the parent-infant relationship and responsiveness, as well as satisfaction with the intervention.

          Results

          No statistically significant group effects were observed for perceived maternal self-efficacy or the secondary outcomes. Over time, perceived maternal self-efficacy increased for mothers in both groups, while anxiety and depression symptoms decreased. High satisfaction with the intervention was reported.

          Conclusions

          The joint observation was not associated with improved perceived maternal self-efficacy or other mental health outcomes, but may constitute an additional supportive measure offered to parents in a vulnerable situation during the NICU stay.

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          Most cited references52

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          G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

          Franz Faul, Edgar Erdfelder, Albert-Georg Lang … (2007)
          G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
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            Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.

            Diane Wild, Alyson Grove, Mona Martin … (2005)
            In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.
            Article 0 comments Cited 797 times – based on 0 reviews     Review now
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              The MOS social support survey

              Cathy Donald Sherbourne, Anita L Stewart (1991)
              Article 0 comments Cited 582 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Juliane Schneider:
                ORCID: https://orcid.org/0000-0001-6849-6178
                Role: Data curationRole: Formal analysisRole: Project administrationRole: SupervisionRole: Writing – original draft
                Mathilde Morisod Harari: Role: ConceptualizationRole: Data curationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Noémie Faure: Role: ConceptualizationRole: MethodologyRole: Writing – original draft
                Alain Lacroix: Role: Formal analysisRole: Writing – original draft
                Ayala Borghini: Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Jean-François Tolsa: Role: ConceptualizationRole: Project administrationRole: Writing – review & editing
                Antje Horsch:
                ORCID: https://orcid.org/0000-0002-9950-9661
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Astawus Alemayehu Feleke: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS One
                Journal ID (publisher-id): plos
                Title: PLOS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 25 April 2024
                Publication date Collection: 2024
                Volume: 19
                Issue: 4
                Electronic Location Identifier: e0301594
                Affiliations
                [1 ] Department of Woman-Mother-Child, Clinic of Neonatology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
                [2 ] The Sense, Innovation, and Research Center, Lausanne, Switzerland
                [3 ] Division of Child and Adolescent Psychiatry, Department of Psychiatry, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
                [4 ] Centre Sages-Femmes, Vevey, Switzerland
                [5 ] UniVers Famille, Châtel-St-Denis, Switzerland
                [6 ] Institute of Higher Education and Research in Healthcare, University of Lausanne, Lausanne, Switzerland
                [7 ] Haute école de travail social, Geneva, Switzerland
                Harar Health Science College, ETHIOPIA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                ¶ The membership list of the JOIN Research Consortium is provided in the Acknowledgments.

                Author information
                https://orcid.org/0000-0001-6849-6178
                https://orcid.org/0000-0002-9950-9661
                Article
                Publisher ID: PONE-D-23-00084
                DOI: 10.1371/journal.pone.0301594
                PMC ID: 11045081
                PubMed ID: 38662661
                SO-VID: 83c85ac2-9418-4736-a481-981a34b02208
                Copyright © © 2024 Schneider et al
                License:

                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.

                History
                Date received : 21 January 2023
                Date accepted : 10 March 2024
                Page count
                Figures: 2, Tables: 3, Pages: 22
                Funding
                The authors received no specific funding for this work.
                Categories
                Subject: Research Article
                Subject: People and Places
                Subject: Population Groupings
                Subject: Age Groups
                Subject: Children
                Subject: Infants
                Subject: People and Places
                Subject: Population Groupings
                Subject: Families
                Subject: Children
                Subject: Infants
                Subject: Biology and Life Sciences
                Subject: Psychology
                Subject: Psychometrics
                Subject: Social Sciences
                Subject: Psychology
                Subject: Psychometrics
                Subject: Biology and Life Sciences
                Subject: Developmental Biology
                Subject: Neonates
                Subject: Medicine and Health Sciences
                Subject: Mental Health and Psychiatry
                Subject: Psychological Stress
                Subject: Biology and Life Sciences
                Subject: Psychology
                Subject: Psychological Stress
                Subject: Social Sciences
                Subject: Psychology
                Subject: Psychological Stress
                Subject: Biology and Life Sciences
                Subject: Psychology
                Subject: Behavior
                Subject: Parenting Behavior
                Subject: Social Sciences
                Subject: Psychology
                Subject: Behavior
                Subject: Parenting Behavior
                Subject: Medicine and Health Sciences
                Subject: Mental Health and Psychiatry
                Subject: Mood Disorders
                Subject: Depression
                Subject: Medicine and Health Sciences
                Subject: Mental Health and Psychiatry
                Subject: Research and Analysis Methods
                Subject: Research Design
                Subject: Survey Research
                Subject: Questionnaires
                Custom metadata
                Data Availability There are legal restrictions on sharing de-identified data set because no consent to do so is available from the participants according to the protocol submttted to the ethics committee in 2015.The data underlying the results presented in the study are available from the Institutional Review Board by contacting Mrs. Jeanne-Pascale Simon ( Jeanne-Pascale.Simon@ 123456chuv.ch ).

                ScienceOpen disciplines: Uncategorized
                Data availability:
                ScienceOpen disciplines: Uncategorized

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