Evaluating a Mental Health Digital Intervention for Dads

NCT06872411 | Not Yet Recruiting

• 1 other identifier: 2025-11066
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health

Outcome Measures

Primary Outcomes (4)

• Engagement with Digital Intervention: Number of Logins

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

  From enrollment to the end of the intervention at 6 weeks

• Intervention Acceptability and Expectancies Questionnaire (IAEQ)

  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.

  From enrollement to the end of the intervention at 6 weeks

• Engagement with Digital Intervention: Number of modules viewed

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

  From enrollment to the end of the intervention at 6 weeks

• Engagement with Digital Intervention: Total number of pages viewed

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

  From enrollment to the end of the intervention at 6 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Other: HealthyDads Digital Intervention

Interventions

HealthyDads Digital Intervention OTHER

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.

HealthyDads web-based program group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Deborah Da Costa, PhD

CONTACT

514-934-1934; deborah.dacosta@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deborah Da Costa, PhD, Associate Professor, Department of Medicine, McGill University; Scientist, RI-MUHC

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 12, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-02