Group Videoconferencing Intervention to Improve Maternal Sensitivity

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Recruiting

CT.gov ID

NCT04904861

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parent-Child Relations Parenting	Behavioral: Videoconference intervention group Other: Control group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Videoconference Intervention group

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

Behavioral: Videoconference intervention group

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. .

Active Comparator: Control group

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

Other: Control group

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

Outcome Measures

Primary Outcome Measures

Feasibility of the intervention: eligibility rates [Through study completion, approximately 18 months]
percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria
Feasibility of the intervention: attrition rates [Through study completion, approximately 18 months]
Attrition and follow-up rates by treatment condition.
Feasibility of the intervention: recruitment rates [Through study completion, approximately 18 months]
percentage that meets entry criteria and agrees to participate
Acceptability of the intervention : participation rates [Through study completion, approximately 18 months]
Proportion of performed sessions versus planned sessions.
Acceptability of the intervention : Satisfaction with the intervention [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.
Acceptability of the intervention (qualitative assessment) [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

Secondary Outcome Measures

Change in Maternal sensitivity [Through study completion, approximately 18 months]
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 [Through study completion, approximately 18 months]
Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores meaning higher depressive symptomatology.
Change in Children Socio Emotional Development [Through study completion, approximately 18 months]
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 [Evaluation at study entry (T0) and at the end of the intervention (T1)]
Maternal postnatal attachment scale (MPAS) : is a 19-item, self-report measure have 19 items, ranging from 1 (low bonding) to 5 (high bonding),

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)