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      A Group Videoconferencing Intervention (C@nnected) to Improve Maternal Sensitivity: Protocol for a Randomized Feasibility Trial


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          Early childhood development is highly dependent on the sensitive care provided by caregivers, and interventions focused on supporting parents to improve their sensitivity have shown to be effective. The COVID-19 pandemic has had a significant impact on mental health, with pregnant women and mothers of infants being an especially vulnerable group and maternal sensitivity particularly affected. However, access to face-to-face interventions is restricted; thus, it is important to have remote interventions to support this group of mothers.


          The objective of this study is to evaluate the feasibility and acceptability of C@nnected, a group videoconferencing intervention to improve maternal sensitivity aimed at mother-infant dyads attending primary health care centers in vulnerable areas of Santiago, Chile.


          This is a randomized feasibility single-masked (outcome assessor) study with a qualitative component. It will involve a block randomization procedure to generate a 3:2 allocation ratio (with more people allocated to the intervention arm). The intervention consists of 4 group videoconferencing sessions adapted from a face-to-face intervention with proven effectiveness. The control group will receive treatment as usual, along with educational brochures. The feasibility and acceptability of this study will be quantitatively and qualitatively assessed. Changes in clinical outcomes relating to maternal sensitivity, depressive symptoms, postpartum maternal attachment, and infant socioemotional development will also be evaluated.


          We finished adapting the face-to-face intervention to the videoconferencing format in July 2021. The study began recruitment in August 2021, and enrollment is expected to end in August 2022, with final study results expected in December 2022.


          This study will contribute evidence for the use of eHealth interventions to promote maternal sensitivity. It will also inform the design and implementation of a future randomized clinical trial.

          Trial Registration

          ClinicalTrials.gov NCT04904861; https://clinicaltrials.gov/ct2/show/NCT04904861

          International Registered Report Identifier (IRRID)


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          Most cited references48

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          Using the framework method for the analysis of qualitative data in multi-disciplinary health research

          Background The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. Discussion The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. Summary Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.
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            SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

            High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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              Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale.

              The development of a 10-item self-report scale (EPDS) to screen for Postnatal Depression in the community is described. After extensive pilot interviews a validation study was carried out on 84 mothers using the Research Diagnostic Criteria for depressive illness obtained from Goldberg's Standardised Psychiatric Interview. The EPDS was found to have satisfactory sensitivity and specificity, and was also sensitive to change in the severity of depression over time. The scale can be completed in about 5 minutes and has a simple method of scoring. The use of the EPDS in the secondary prevention of Postnatal Depression is discussed.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                August 2022
                15 August 2022
                : 11
                : 8
                : e35881
                [1 ] Deparment of Family Medicine Medicine Faculty Pontificia Universidad Católica de Chile Santiago Chile
                [2 ] School of Psychology Social Sciences Faculty Pontificia Universidad Católica de Chile Santiago Chile
                Author notes
                Corresponding Author: Victoria Binda vbinda@ 123456uc.cl
                Author information
                ©Victoria Binda, Marcia Olhaberry, Carla Castañon, Constanza Abarca, Catalina Caamaño. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.08.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 22 December 2021
                : 26 April 2022
                : 9 June 2022
                : 10 June 2022

                maternal sensitivity,group intervention,primary care,ehealth,responsive caregiving,videoconferencing,early childhood,caregiver,ehealth intervention,health intervention,parenting,children,peer-support


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