Evaluating a Mental Health Digital Intervention for Dads

Официальное название

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

Обзор

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.

Вмешательства

• Другое HealthyDads Digital Intervention
  HealthyDads is a prototype bilingual self-guided psychoeducational Digital Intervention with accurate and easily accessible information on topics related to mental health, parenting and health behaviors, along with strategies to optimize each.

Первичные конечные точки

• Engagement with Digital Intervention: Number of Logins [Срок оценки: From enrollment to the end of the intervention at 6 weeks]
• Intervention Acceptability and Expectancies Questionnaire (IAEQ) [Срок оценки: From enrollement to the end of the intervention at 6 weeks]
• Engagement with Digital Intervention: Number of modules viewed [Срок оценки: From enrollment to the end of the intervention at 6 weeks]
• Engagement with Digital Intervention: Total number of pages viewed [Срок оценки: From enrollment to the end of the intervention at 6 weeks]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06872411 · 2025-11066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗