Group Videoconferencing Intervention to Improve Maternal Sensitivity
Primary Purpose
Parent-Child Relations, Parenting
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Videoconference intervention group
Control group
Sponsored by
About this trial
This is an interventional prevention trial for Parent-Child Relations focused on measuring maternal sensitivity, videoconferencing, group intervention, primary care, telehealth
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
Sites / Locations
- CESFAM Juan Pablo Segundo ANCORA UC Christus
- CESFAM Madre Teresa Calcuta ANCORA UC Christus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Videoconference Intervention group
Control group
Arm Description
Brief group videoconferencing attachment-based intervention (sessions once a week for 4 weeks)
Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks)
Outcomes
Primary Outcome Measures
Feasibility of the intervention: eligibility rates
percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria
Feasibility of the intervention: attrition rates
Attrition and follow-up rates by treatment condition.
Feasibility of the intervention: recruitment rates
percentage that meets entry criteria and agrees to participate
Acceptability of the intervention : participation rates
Proportion of performed sessions versus planned sessions.
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.
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
Secondary Outcome Measures
Change in Maternal sensitivity
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
Change in Maternal Depressive Symptoms
Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores meaning higher depressive symptomatology.
Change in Children Socio Emotional Development
Ages and Stages Questionnaire (ASQ-SE). Scores range from 0 to 75 with higher scores meaning lower socio-emotional development
Change in postnatal maternal bonding
Maternal postnatal attachment scale (MPAS) : is a 19-item, self-report measure have 19 items, ranging from 1 (low bonding) to 5 (high bonding),
Full Information
NCT ID
NCT04904861
First Posted
May 17, 2021
Last Updated
March 27, 2023
Sponsor
Pontificia Universidad Catolica de Chile
1. Study Identification
Unique Protocol Identification Number
NCT04904861
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parent-Child Relations, Parenting
Keywords
maternal sensitivity, videoconferencing, group intervention, primary care, telehealth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videoconference Intervention group
Arm Type
Experimental
Arm Description
Brief group videoconferencing attachment-based intervention (sessions once a week for 4 weeks)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Videoconference intervention group
Intervention Description
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
Other
Intervention Name(s)
Control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of the intervention: eligibility rates
Description
percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria
Time Frame
Through study completion, approximately 18 months
Title
Feasibility of the intervention: attrition rates
Description
Attrition and follow-up rates by treatment condition.
Time Frame
Through study completion, approximately 18 months
Title
Feasibility of the intervention: recruitment rates
Description
percentage that meets entry criteria and agrees to participate
Time Frame
Through study completion, approximately 18 months
Title
Acceptability of the intervention : participation rates
Description
Proportion of performed sessions versus planned sessions.
Time Frame
Through study completion, approximately 18 months
Title
Acceptability of the intervention : Satisfaction with the intervention
Description
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
Title
Acceptability of the intervention (qualitative assessment)
Description
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
Secondary Outcome Measure Information:
Title
Change in Maternal sensitivity
Description
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
Title
Change in Maternal Depressive Symptoms
Description
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
Title
Change in Children Socio Emotional Development
Description
Ages and Stages Questionnaire (ASQ-SE). Scores range from 0 to 75 with higher scores meaning lower socio-emotional development
Time Frame
Through study completion, approximately 18 months
Title
Change in postnatal maternal bonding
Description
Maternal postnatal attachment scale (MPAS) : is a 19-item, self-report measure have 19 items, ranging from 1 (low bonding) to 5 (high bonding),
Time Frame
Evaluation at study entry (T0) and at the end of the intervention (T1)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CESFAM Juan Pablo Segundo ANCORA UC Christus
City
Santiago
ZIP/Postal Code
7610682
Country
Chile
Facility Name
CESFAM Madre Teresa Calcuta ANCORA UC Christus
City
Santiago
ZIP/Postal Code
7610682
Country
Chile
12. IPD Sharing Statement
Citations:
PubMed Identifier
34816146
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.
Results Reference
background
PubMed Identifier
27717614
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.
Results Reference
result
PubMed Identifier
27717615
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.
Results Reference
result
PubMed Identifier
32233719
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.
Results Reference
result
PubMed Identifier
32238336
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.
Results Reference
result
PubMed Identifier
35969451
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.
Results Reference
derived
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Group Videoconferencing Intervention to Improve Maternal Sensitivity
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