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Group Videoconferencing Intervention to Improve Maternal Sensitivity

NCT04904861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-03-29

No results posted yet for this study

Summary

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 , with pregnant women and mothers of children under one year of age being an especially vulnerable group . On the other hand, access to mental health interventions in person is restricted by confinement measures , especially group interventions, so it is relevant to have remote interventions that support this group of mothers.

Objectives: to evaluate the feasibility and acceptability of a group videoconferencing intervention to improve maternal sensitivity aimed at mother / infant dyads attended in Primary Health Care in Chile Methodology: a randomized pilot feasibility study will be carried out with a mixed design with quantitative and qualitative evaluations. A face-to-face group intervention with proven effectiveness will be adapted to videoconferencing format , then 50 dyads will be randomized in a 3: 2 ratio to receive the videoconferencing intervention ( n=30) or the delivery of educational brochures (n=20) . The feasibility and acceptability will be evaluated assessing the participation, adherence and satisfaction in a quantitative way, in addition the qualitative evaluation will be carried out through interviews and focus groups. Changes in clinical outcomes will also be evaluated: maternal sensitivity, depressive symptoms, postnatal maternal attachment and infant socio-emotional development. This pilot study will allow the identification of the key parameters for the implementation and evaluation of the intervention, which will allow the design of an effectiveness study in the future.

Conditions

  • Parent-Child Relations
  • Parenting

Interventions

BEHAVIORAL

Videoconference intervention group

A short face-to-face dyadic group workshop focused on increasing maternal sensitivity was adapted to be carried out virtually by videoconference. The intervention considers 4 sessions, with a weekly frequency, with a minimum of 3 and a maximum of 6 dyads per group led by a monitor (psychologist). The activities are protocolized in a manual and are designed to be carried out by the mother with the baby under one year of age. .

OTHER

Control group

Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks) in addition to the usual care in their primary care center

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04904861 on ClinicalTrials.gov