Skip to content

Group Videoconferencing Intervention to Improve Maternal Sensitivity

Group Videoconferencing Intervention to Improve Maternal Sensitivity in Mother-infant Dyads in Primary Care in Chile : Randomized Controlled Feasibility Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04904861
Enrollment
44
Registered
2021-05-27
Start date
2021-07-30
Completion date
2022-12-30
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parent-Child Relations, Parenting

Keywords

maternal sensitivity, videoconferencing, group intervention, primary care, telehealth

Brief 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.

Interventions

BEHAVIORALVideoconference 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. .

OTHERControl 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

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Mother of a baby between 4 months and a year * Attended at one of the participating primary care health centers * Older than 18 years-old * Handling Spanish fluently * Have an electronic device that allows videoconferencing (computer, tablet or smart cell phone)

Exclusion criteria

* Mother with severe intellectual deficit or psychotic symptoms * Participate in another early intervention at the health care center

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the intervention (qualitative assessment)Through study completion, approximately 18 monthsSemi-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
Feasibility of the intervention: attrition ratesThrough study completion, approximately 18 monthsAttrition and follow-up rates by treatment condition.
Feasibility of the intervention: recruitment ratesThrough study completion, approximately 18 monthspercentage that meets entry criteria and agrees to participate
Acceptability of the intervention : participation ratesThrough study completion, approximately 18 monthsProportion of performed sessions versus planned sessions.
Acceptability of the intervention : Satisfaction with the interventionThrough study completion, approximately 18 monthsCredibility/Expectancy Questionnaire (CEQ).Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention.
Feasibility of the intervention: eligibility ratesThrough study completion, approximately 18 monthspercentage of eligible population that is recruitable: meets inclusion and not exclusion criteria

Secondary

MeasureTime frameDescription
Change in Maternal Depressive SymptomsThrough study completion, approximately 18 monthsEdinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores meaning higher depressive symptomatology.
Change in Children Socio Emotional DevelopmentThrough study completion, approximately 18 monthsAges and Stages Questionnaire (ASQ-SE). Scores range from 0 to 75 with higher scores meaning lower socio-emotional development
Change in postnatal maternal bondingEvaluation 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),
Change in Maternal sensitivityThrough study completion, approximately 18 monthsAdult Sensitivity Scale (E.S.A.) rubric with 19 indicators, each indicator is scored between 1 and 3, and a higher score indicates higher sensitivity

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026