NCT Number: NCT04904861
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
CESFAM Juan Pablo Segundo ANCORA UC Christus, Santiago, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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. .
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
Time frame: Through study completion, approximately 18 months
percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria
Time frame: Through study completion, approximately 18 months
Attrition and follow-up rates by treatment condition.
Time frame: Through study completion, approximately 18 months
percentage that meets entry criteria and agrees to participate
Time frame: Through study completion, approximately 18 months
Proportion of performed sessions versus planned sessions.
Time frame: Through study completion, approximately 18 months
Credibility/Expectancy Questionnaire (CEQ).Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention.
Time frame: Through study completion, approximately 18 months
Semi-structured interviews with monitors of the intervention (two psychologists) and focus groups with participating mothers (7 in total) with the aim of collecting information about the experience and identifying possible improvements
Time frame: Through study completion, approximately 18 months
Adult Sensitivity Scale (E.S.A.) rubric with 19 indicators, each indicator is scored between 1 and 3, and a higher score indicates higher sensitivity
Time frame: Through study completion, approximately 18 months
Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores meaning higher depressive symptomatology.
Time frame: Through study completion, approximately 18 months
Ages and Stages Questionnaire (ASQ-SE). Scores range from 0 to 75 with higher scores meaning lower socio-emotional development
Time frame: Evaluation at study entry (T0) and at the end of the intervention (T1)
Maternal postnatal attachment scale (MPAS) : is a 19-item, self-report measure have 19 items, ranging from 1 (low bonding) to 5 (high bonding),
Pontificia Universidad Catolica de Chile
Other
Group Videoconferencing Intervention to Improve Maternal Sensitivity in Mother-infant Dyads in Primary Care in Chile : Randomized Controlled Feasibility Trial
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