Group Videoconferencing Intervention to Improve Maternal Sensitivity

NCT04904861 | Completed

• 1 other identifier: INTERDISCIPLINA II20029
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Parent-Child Relations; Parenting

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Feasibility of the intervention: eligibility rates

  percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria

  Through study completion, approximately 18 months

• Feasibility of the intervention: attrition rates

  Attrition and follow-up rates by treatment condition.

  Through study completion, approximately 18 months

• Feasibility of the intervention: recruitment rates

  percentage that meets entry criteria and agrees to participate

  Through study completion, approximately 18 months

• Acceptability of the intervention : participation rates

  Proportion of performed sessions versus planned sessions.

  Through study completion, approximately 18 months

• Acceptability of the intervention : Satisfaction with the intervention

  Credibility/Expectancy Questionnaire (CEQ).Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention.

  Through study completion, approximately 18 months

• Acceptability of the intervention (qualitative assessment)

  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

  Through study completion, approximately 18 months

Secondary Outcomes (4)

• Change in Maternal sensitivity

  Through study completion, approximately 18 months

• Change in Maternal Depressive Symptoms

  Through study completion, approximately 18 months

• Change in Children Socio Emotional Development

  Through study completion, approximately 18 months

• Change in postnatal maternal bonding

  Evaluation at study entry (T0) and at the end of the intervention (T1)

Study Arms (2)

Videoconference Intervention group

EXPERIMENTAL

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

Behavioral: Videoconference intervention group

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

Videoconference intervention group 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. .

Videoconference Intervention group

Control group 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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (2)

CESFAM Juan Pablo Segundo ANCORA UC Christus

Santiago, 7610682, Chile

Location

CESFAM Madre Teresa Calcuta ANCORA UC Christus

Santiago, 7610682, Chile

Location

Related Publications (6)

• 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.

  PMID: 34816146 BACKGROUND

• 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.

  PMID: 27717614 RESULT

• 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.

  PMID: 27717615 RESULT

• 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.

  PMID: 32233719 RESULT

• 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.

  PMID: 32238336 RESULT

• 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.

  PMID: 35969451 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: July 30, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 29, 2023

Record last verified: 2022-12

Locations

CL (2)