Mental HealthHealthyDadsNCT06872411
Evaluating a Mental Health Digital Intervention for Dads
A study testing HealthyDads Digital Intervention in people with Mental Health, run by McGill University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mental Health
- What is being tested?
- HealthyDads Digital Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- suicidal ideation or intent
- score ≥12 on the EPDS
- having a severe psychiatric disorder as reported by the participant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Mental Health
- Being tested
- HealthyDads Digital Intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyDads Digital InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HealthyDads Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of the intervention at 6 weeks
Secondary outcomes (3)
Edinburgh Postnatal Depression Scale (EPDS)
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.
Measured: From enrollment to the end of follow-up at 12 months following the birth of their baby
Male Depression Risk Scale (MDRS-22)
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.
Measured: From enrollment to the end of follow-up at 12 months following the birth of their baby
Generalized Anxiety Disorder 7-item (GAD-7)
The Generalized Anxiety Disorder 7-item (GAD-7) scale is scored from 0 to 21, with higher scores indicating more severe anxiety.
Measured: From enrollment to the end of follow-up 12 months after the birth of their baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Deborah Da Costa, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872411
- Sponsor's protocol ID
- 2025-11066
- Other IDs
- 2025
- Acronym
- HealthyDads
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Acceptability and Feasibility of an Enhanced Digital Intervention for Preventing Postpartum Mental Health Difficulties in Fathers
- ClinicalTrials.gov ID
- NCT06872411
- Acronym / sponsor ID
- HealthyDads / 2025-11066
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HealthyDads web-based program group | Experimental | Other: HealthyDads Digital InterventionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- suicidal ideation or intent
- score ≥12 on the EPDS
- having a severe psychiatric disorder as reported by the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthyDads Digital InterventionHealthyDads 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. | Other | HealthyDads web-based program group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing HealthyDads Digital Intervention in people with Mental Health, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Da Costa, PhD (514-934-1934 ext. 44723, deborah.dacosta@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with Digital Intervention: Number of Logins (time frame: From enrollment to the end of the intervention at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.