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临床试验/NCT04904861
NCT04904861已完成不适用

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

Pontificia Universidad Catolica de Chile2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Acceptability of the intervention : participation rates

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •Mother with severe intellectual deficit or psychotic symptoms
  • •Participate in another early intervention at the health care center

研究组 & 干预措施

Videoconference Intervention group

Experimental

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

干预措施: Videoconference intervention group (Behavioral)

Control group

Active Comparator

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

干预措施: Control group (Other)

结局指标

主要结局

Acceptability of the intervention : participation rates

时间窗: Through study completion, approximately 18 months

Proportion of performed sessions versus planned sessions.

Feasibility of the intervention: attrition rates

时间窗: Through study completion, approximately 18 months

Attrition and follow-up rates by treatment condition.

Acceptability of the intervention (qualitative assessment)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Through study completion, approximately 18 months

percentage that meets entry criteria and agrees to participate

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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