Group Videoconferencing Intervention to Improve Maternal Sensitivity

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904861
• Other study ID #: INTERDISCIPLINA II20029
• Status: Completed
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Parent-Child Relations
• Parenting

Intervention

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. .

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

Locations

Country	Name	City	State
Chile	CESFAM Juan Pablo Segundo ANCORA UC Christus	Santiago
Chile	CESFAM Madre Teresa Calcuta ANCORA UC Christus	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (5)

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 develo — View 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, f — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility of the intervention: attrition rates	Attrition and follow-up rates by treatment condition.	Through study completion, approximately 18 months
Primary	Feasibility of the intervention: recruitment rates	percentage that meets entry criteria and agrees to participate	Through study completion, approximately 18 months
Primary	Acceptability of the intervention : participation rates	Proportion of performed sessions versus planned sessions.	Through study completion, approximately 18 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)