Group Videoconferencing Intervention to Improve Maternal Sensitivity

NCT ID: NCT04904861

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parent-Child Relations Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Videoconference Intervention group

Brief group videoconferencing attachment-based intervention (sessions once a week for 4 weeks)

Group Type EXPERIMENTAL

Videoconference intervention group

Intervention Type BEHAVIORAL

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. .

Control group

Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks)

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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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. .

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CESFAM Juan Pablo Segundo ANCORA UC Christus

Santiago, , Chile

Site Status

CESFAM Madre Teresa Calcuta ANCORA UC Christus

Santiago, , Chile

Site Status

Countries

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Chile

References

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Davenport MH, Meyer S, Meah VL, Strynadka MC, Khurana R. Moms Are Not OK: COVID-19 and Maternal Mental Health. Front Glob Womens Health. 2020 Jun 19;1:1. doi: 10.3389/fgwh.2020.00001. eCollection 2020.

Reference Type BACKGROUND
PMID: 34816146 (View on PubMed)

Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.

Reference Type RESULT
PMID: 27717614 (View on PubMed)

Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4.

Reference Type RESULT
PMID: 27717615 (View on PubMed)

Torales J, O'Higgins M, Castaldelli-Maia JM, Ventriglio A. The outbreak of COVID-19 coronavirus and its impact on global mental health. Int J Soc Psychiatry. 2020 Jun;66(4):317-320. doi: 10.1177/0020764020915212. Epub 2020 Mar 31.

Reference Type RESULT
PMID: 32233719 (View on PubMed)

Ohannessian R, Duong TA, Odone A. Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action. JMIR Public Health Surveill. 2020 Apr 2;6(2):e18810. doi: 10.2196/18810.

Reference Type RESULT
PMID: 32238336 (View on PubMed)

Binda V, Olhaberry M, Castanon C, Abarca C, Caamano C. A Group Videoconferencing Intervention (C@nnected) to Improve Maternal Sensitivity: Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2022 Aug 15;11(8):e35881. doi: 10.2196/35881.

Reference Type DERIVED
PMID: 35969451 (View on PubMed)

Other Identifiers

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INTERDISCIPLINA II20029

Identifier Type: -

Identifier Source: org_study_id

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