Clinical trial NCT04904861: Group Videoconferencing Intervention to Improve Maternal Sensitivity
Official title: Group Videoconferencing Intervention to Improve Maternal Sensitivity in Mother-infant Dyads in Primary Care in Chile : Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parenting
Keywords: maternal sensitivity
videoconferencing
group intervention
primary care
telehealth
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention: eligibility rates
timeFrame: Through study completion, approximately 18 months
measure: Feasibility of the intervention: attrition rates
timeFrame: Through study completion, approximately 18 months
measure: Feasibility of the intervention: recruitment rates
timeFrame: Through study completion, approximately 18 months
measure: Acceptability of the intervention : participation rates
timeFrame: Through study completion, approximately 18 months
measure: Acceptability of the intervention : Satisfaction with the intervention
timeFrame: Through study completion, approximately 18 months
measure: Acceptability of the intervention (qualitative assessment)
timeFrame: Through study completion, approximately 18 months
Secondary outcomes:
measure: Change in Maternal sensitivity
timeFrame: Through study completion, approximately 18 months
measure: Change in Maternal Depressive Symptoms
timeFrame: Through study completion, approximately 18 months
measure: Change in Children Socio Emotional Development
timeFrame: Through study completion, approximately 18 months
measure: Change in postnatal maternal bonding
timeFrame: Evaluation at study entry (T0) and at the end of the intervention (T1)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CESFAM Juan Pablo Segundo ANCORA UC Christus
city: Santiago
country: Chile
facility: CESFAM Madre Teresa Calcuta ANCORA UC Christus
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.