Group Videoconferencing Intervention to Improve Maternal Sensitivity

Study Overview
=================
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.

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

Conditions
-----------------
Parent-Child Relations, Parenting

Intervention / Treatment
-----------------
* Behavioral: Videoconference intervention group
* Other: Control group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videoconference Intervention group<br>Brief group videoconferencing attachment-based intervention (sessions once a week for 4 weeks) | Behavioral: Videoconference intervention group<br>* 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. .<br>|
| Active Comparator: Control group<br>Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks) | Other: Control group<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, approximately 18 months | 
| Change in Maternal Depressive Symptoms | Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores meaning higher depressive symptomatology. | Through study completion, approximately 18 months | 
| 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 | Through study completion, approximately 18 months | 
| 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), | Evaluation at study entry (T0) and at the end of the intervention (T1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maternal sensitivity, videoconferencing, group intervention, primary care, telehealth