Clinical trial NCT06872411: Evaluating a Mental Health Digital Intervention for Dads
Official title: Evaluating Acceptability and Feasibility of an Enhanced Digital Intervention for Preventing Postpartum Mental Health Difficulties in Fathers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2025-03-12
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Engagement with Digital Intervention: Number of Logins
timeFrame: From enrollment to the end of the intervention at 6 weeks
measure: Intervention Acceptability and Expectancies Questionnaire (IAEQ)
timeFrame: From enrollement to the end of the intervention at 6 weeks
measure: Engagement with Digital Intervention: Number of modules viewed
timeFrame: From enrollment to the end of the intervention at 6 weeks
measure: Engagement with Digital Intervention: Total number of pages viewed
timeFrame: From enrollment to the end of the intervention at 6 weeks
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: From enrollment to the end of follow-up at 12 months following the birth of their baby
measure: Male Depression Risk Scale (MDRS-22)
timeFrame: From enrollment to the end of follow-up at 12 months following the birth of their baby
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: From enrollment to the end of follow-up 12 months after the birth of their baby
Other outcomes:
Locations:
Study officials:
References: