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Evaluating a Mental Health Digital Intervention for Dads

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06872411
Acronym
HealthyDads
Enrollment
100
Registered
2025-03-12
Start date
2025-03-15
Completion date
2027-03-01
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health

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.

Interventions

OTHERHealthyDads 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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
McGill University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Engagement with Digital Intervention: Number of LoginsFrom enrollment to the end of the intervention at 6 weeksTo 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)From enrollement to the end of the intervention at 6 weeksEvaluates 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 viewedFrom enrollment to the end of the intervention at 6 weeksIn 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 viewedFrom enrollment to the end of the intervention at 6 weeksIn order to evaluate the engagement with the digital intervention HealthDads, the investigators will track the total number of intervention pages each participant views.

Secondary

MeasureTime frameDescription
Male Depression Risk Scale (MDRS-22)From enrollment to the end of follow-up at 12 months following the birth of their babyThe Male Depression Risk Scale will assess masculine depressive symptoms. The minimum score is 0 and maximum is 154 with higher scores indicative of a greater risk of significant depressive symptoms.
Generalized Anxiety Disorder 7-item (GAD-7)From enrollment to the end of follow-up 12 months after the birth of their babyThe Generalized Anxiety Disorder 7-item (GAD-7) scale is scored from 0 to 21, with higher scores indicating more severe anxiety.
Edinburgh Postnatal Depression Scale (EPDS)From enrollment to the end of follow-up at 12 months following the birth of their babyThe Edinburgh Postnatal Depressive Scale is a 10 question screening tool used to evaluate depressive symptoms. The minimum score is 0 and maximum is 30 with a higher score indicating more severe depression.

Contacts

Primary ContactDeborah Da Costa, PhD
deborah.dacosta@mcgill.ca514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026