“C@nnected” : Group videoconferencing intervention to improve maternal sensitivity in mothers-infant dyads attending primary care in Chile: Protocol for a randomized feasibility trial (Preprint)

Abstract

BACKGROUND Early childhood development is highly dependent on the sensitive care provided by their caregivers. Interventions focused on supporting parents to improve their sensitivity have been shown to be effective. The COVID-19 pandemic has had a great impact on mental health. Pregnant women and mothers of infants being an especially vulnerable group, and maternal sensitivity is particularly affected. On the other hand, access to face-to-face interventions is restricted, above all group interventions, so it is relevant to have remote interventions to support this group of mothers. OBJECTIVE The objective of the study is to evaluate the feasibility and acceptability of a group videoconferencing intervention : “C@nnected” to improve maternal sensitivity aimed at mother-infant dyads attended in Primary Health Care in vulnerable areas of Santiago , Chile. METHODS This is a randomized pilot feasibility study single-masked (outcome assessor) study with a qualitative component. It will involve a block randomization procedure to generate a 3:2 allocation (with more people allocated to the intervention arm). The intervention consists of four group videoconferencing sessions, adapted from a face-to-face intervention of proven effectiveness. The control group will receive treatment as usual plus educational brochures. Feasibility and acceptability of the study will be quantitatively and qualitatively assessed. Changes in clinical outcomes will also be evaluated: maternal sensitivity, depressive symptoms, postnatal maternal attachment, and infant socio-emotional development. RESULTS We have completed the adaptation of the face-to-face intervention to the videoconferencing format, our study is currently in the recruitment phase, which is expected to be completed by January 2022, the results of the study are expected by August 2022. CONCLUSIONS 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. CLINICALTRIAL ClinicalTrials.gov, NCT04904861.