Evaluating a Mental Health Digital Intervention for Dads (HealthyDads)

March 6, 2025 updated by: Deborah Da Costa, McGill University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HealthyDads web-based program group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the intervention at 6 weeks
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.
From enrollement to the end of the intervention at 6 weeks
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.
From enrollment to the end of the intervention at 6 weeks
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.
From enrollment to the end of the intervention at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow-up at 12 months following the birth of their baby
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.
From enrollment to the end of follow-up at 12 months following the birth of their baby
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.
From enrollment to the end of follow-up 12 months after the birth of their baby

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-11066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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