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临床试验/NCT04748731
NCT04748731已完成不适用

Internet Mentalization-based Video Feedback Intervention to Improve Parental Sensitivity in Mother-infant Dyads With Maternal Depressive Symptoms: Randomized Controlled Feasibility Trial

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年3月1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
86
试验地点
1
主要终点
Change in Maternal sensitivity

研究概览

简要总结

Title: "Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms: randomized controlled feasibility trial". Funding: ANID Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP ICS13_005 (MIDAP, www.midap.org).

Principal Investigator: Marcia Olhaberry Huber, PhD, Academic, School of Psychology, Pontificia Universidad Católica de Chile, Associate Researcher, MIDAP.

MIDAP Research Team: Javier Moran, PhD. Academic at the University of Valparaíso, María José León, PhD, Stefanella Costa, PhD. and Fanny Leyton, PhD. (c) University of Valparaíso.

General Objective: To evaluate feasibility and acceptability of a brief Internet mentalization-based video feedback intervention to improve sensitivity in mothers with depressive symptoms. Key parameters for a future effectiveness study will be identified

Design: Pilot randomized clinical trial; Participants: 60 mother-infant dyads (aged 4-12 months) attended in Public Health Centres.30 dyads will be assigned to the experimental group (EG) and will receive a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting. 30 dyads will be assigned to the control group (CG) and will receive only psycho-educational materials. The study includes 3 assessments (pre-intervention, post-intervention and follow-up) and four weekly intervention sessions. Data analysis: For quantitative data descriptive statistics and ANCOVA will be used, for qualitative data Grounded Theory.

详细描述

Background A growing body of research recognises the key role of both parental sensitivity and mentalizing in fostering positive parent-child relationships. This, in turn, is fundamental for a child's mental health and intergenerational transmission of attachment.

Parental sensitivity concerns a parent's ability to perceive and interpret their child's cues accurately and to respond accordingly in a contingent manner (Ainsworth et al., 1978). Parental sensitivity has been associated with the development of attachment and general socio-emotional development in childhood. The association between parental sensitivity and cognitive variables like joint attention, executive functioning development in early childhood and Theory of Mind in preschoolers has also demonstrated it.

The caregiver's capacity to think of his/her child in terms of mental state (i.e., parental mentalizing or parental reflective functioning) is linked with the development of affect regulation in the child, with the intergenerational transmission of attachment and with the development of social and reflective abilities in childhood. Evidence also suggests that mentalizing may constitute a protective factor for the transmission of psychopathology in childhood.

*THE INTERVENTION*

The present intervention aims to improve parental sensitivity and mentalizing in depressed mothers using a model based on video-feedback methodology in an online modality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Mother must be over 18 years old
  • •Mother must have a 4 to 12 months infant
  • •Mother must be a user of primary public health
  • •Mother must score at least 5 points in the EPDS during routine health controls in health centres

排除标准

  • •Mothers presenting severe intellectual deficit or psychotic symptoms.
  • •Infants presenting developmental disorders and/or at high risk of abuse or neglect

研究组 & 干预措施

Experimental Group. Video-feedback intervention.

Experimental

A weekly online brief intervention using video-feedback and psycho-educational materials on early parenting (detailed description of the intervention on section 5).

干预措施: Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms (Behavioral)

Control Group. Psycho-educational intervention

Other

They will receive weekly information on parenting in the 1st year of life. They will have direct contact (via WhatsApp) with a child psychologist to ask questions about the material and to refer to specialized support if needed.

干预措施: Psycho-Educational Intervention (Behavioral)

结局指标

主要结局

Change in Maternal sensitivity

时间窗: before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.

Emotional Availability Scale (EAS). Scores range from 0 to 10o with higher scores indicating higher emotional availability. Therefore, higher scores mean better outcomes.

次要结局

  • Change in Parental Reflective Functioning(before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.)
  • Change in Maternal Depressive Symptoms Measured with EPDS(before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.)
  • Change in Maternal Depressive Symptoms Measured with CORE OM(before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.)
  • Change in Maternal Depressive Symptoms Measured with PHQ 9(before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.)
  • Change in Children Socio Emotional Development(before the intervention; through study completion, an average of 1 year; and a 3 months follow-up.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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