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NCT Number: NCT06872411

Evaluating a Mental Health Digital Intervention for Dads

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.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Engagement with Digital Intervention: Number of Logins

    Time frame: 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.

  2. Intervention Acceptability and Expectancies Questionnaire (IAEQ)

    Time frame: 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.

  3. Engagement with Digital Intervention: Number of modules viewed

    Time frame: 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.

  4. Engagement with Digital Intervention: Total number of pages viewed

    Time frame: 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 outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 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.

  2. Male Depression Risk Scale (MDRS-22)

    Time frame: 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.

  3. Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Da Costa, PhD

CONTACT

[email protected]

514-934-1934 ext. 44723

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: HealthyDads

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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