Evaluating a Mental Health Digital Intervention for Dads

Not Applicable

Not yet recruiting

• Conditions: Mental Health

• Registration Number: NCT06872411
• Lead Sponsor: McGill University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Study Start: 2025-03-15
• Primary Completion: 2026-09-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Engagement with Digital Intervention: Number of Logins	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)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (EPDS)	From enrollment to the end of follow-up at 12 months following the birth of their baby	The 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.
Male Depression Risk Scale (MDRS-22)	From enrollment to the end of follow-up at 12 months following the birth of their baby	The 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 baby	The Generalized Anxiety Disorder 7-item (GAD-7) scale is scored from 0 to 21, with higher scores indicating more severe anxiety.