Group Videoconferencing Intervention to Improve Maternal Sensitivity in Mother-infant Dyads in Primary Care in Chile : Randomized Controlled Feasibility Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parent-Child Relations
- Sponsor
- Pontificia Universidad Catolica de Chile
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Acceptability of the intervention : participation rates
- Status
- Completed
- Last Updated
- 3 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
Acceptability of the intervention : participation rates
Time Frame: Through study completion, approximately 18 months
Proportion of performed sessions versus planned sessions.
Feasibility of the intervention: attrition rates
Time Frame: Through study completion, approximately 18 months
Attrition and follow-up rates by treatment condition.
Acceptability of the intervention (qualitative assessment)
Time Frame: Through study completion, approximately 18 months
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
Feasibility of the intervention: eligibility rates
Time Frame: Through study completion, approximately 18 months
percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria
Acceptability of the intervention : Satisfaction with the intervention
Time Frame: Through study completion, approximately 18 months
Credibility/Expectancy Questionnaire (CEQ).Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention.
Feasibility of the intervention: recruitment rates
Time Frame: Through study completion, approximately 18 months
percentage that meets entry criteria and agrees to participate
Secondary Outcomes
- Change in postnatal maternal bonding(Evaluation at study entry (T0) and at the end of the intervention (T1))
- 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 Maternal sensitivity(Through study completion, approximately 18 months)