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临床试验/NCT06872411
NCT06872411尚未招募不适用

Evaluating Acceptability and Feasibility of an Enhanced Digital Intervention for Preventing Postpartum Mental Health Difficulties in Fathers

McGill University0 个研究点目标入组 100 人开始时间: 2025年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Engagement with Digital Intervention: Number of Logins

研究概览

简要总结

Approximately one in 10 fathers experience mental health difficulties during their partner's pregnancy and/or the postpartum period. There is a need for routine depression screening and timely interventions for fathers in the postpartum however there is a lack of resources tailored to men. To fill this gap, the investigators developed HealthyDads which includes up-to-date information and strategies related to i) prevention or reduction of stress and depressive symptoms; ii) parenting skills preparation tailored to expectant dads and iii) healthy lifestyle promotion for men at risk for depression. The investigators objective is to evaluate the acceptability of the HealthDads website targeting the mental health of at risk expectant fathers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Fathers-to-be who:
  • •reside in Canada
  • •able to communicate in French or English
  • •gestational age of partner's pregnancy between 14-28 weeks
  • •internet access
  • •score <12 on the EPDS
  • •at least 1 risk factor for depression if they score <6 on the EPDS: a) history of depression; b) elevated anxiety (score >10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale)116; or c) couple discord (established cutoff score <13 on the 4-item Dyadic Adjustment Scale117 or Pittsburgh Sleep Quality Index global score >5

排除标准

  • •suicidal ideation or intent
  • •score ≥12 on the EPDS
  • •having a severe psychiatric disorder as reported by the participant

研究组 & 干预措施

HealthyDads web-based program group

Experimental

All participants in the study will be asked to use the HealthyDads website which includes up-to-date information and strategies related to i) prevention or reduction of stress and depressive symptoms; ii) parenting skills preparation tailored to expectant dads and iii) healthy lifestyle promotion for men at risk for depression.

干预措施: HealthyDads Digital Intervention (Other)

结局指标

主要结局

Engagement with Digital Intervention: Number of Logins

时间窗: From enrollment to the end of the intervention at 6 weeks

To evaluate participant engagement with the digital intervention HealthDads, the investigators will track the number of times the participant logs into the intervention.

Intervention Acceptability and Expectancies Questionnaire (IAEQ)

时间窗: From enrollement to the end of the intervention at 6 weeks

Evaluates users' acceptance of the DI and potential barriers and facilitators to acceptance. Scale of minimum value 1 to a maximum value of 5 where a higher score indicates a better outcome.

Engagement with Digital Intervention: Number of modules viewed

时间窗: From enrollment to the end of the intervention at 6 weeks

In order to evaluate the engagement with the digital intervention HealthDads, the investigators will track the number of modules each participant views.

Engagement with Digital Intervention: Total number of pages viewed

时间窗: From enrollment to the end of the intervention at 6 weeks

In order to evaluate the engagement with the digital intervention HealthDads, the investigators will track the total number of intervention pages each participant views.

次要结局

  • Edinburgh Postnatal Depression Scale (EPDS)(From enrollment to the end of follow-up at 12 months following the birth of their baby)
  • Male Depression Risk Scale (MDRS-22)(From enrollment to the end of follow-up at 12 months following the birth of their baby)
  • Generalized Anxiety Disorder 7-item (GAD-7)(From enrollment to the end of follow-up 12 months after the birth of their baby)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Da Costa

Deborah Da Costa, PhD, Associate Professor, Department of Medicine, McGill University; Scientist, RI-MUHC

McGill University

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