Mental Health in Expectant First-time FathersNCT02503670
An Intervention Study to Evaluate a Website Tailored to New Dads to Promote Mental Health
A study testing Psychoeducational modules to prevent/reduce depression in people with Mental Health in Expectant First-time Fathers, run by McGill University at 3 sites in Canada.
Trial summary
The purpose of this study is to develop and pilot test HealthyDads.ca, a website for expectant first-time fathers who have known risk factors for depression. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health in Expectant First-time Fathers
- What is being tested?
- Psychoeducational modules to prevent/reduce depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2015to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to communicate in French or English
- Either married or cohabiting at the time of study entry
- First child for both partners
- Have internet access
- Score <12 on the Edinburgh Postnatal Depression Scale (EPDS)
- Not currently receiving psychotherapy from a health professional or on medication for a mental disorder
- At least 1 risk factor for depression if they score < 6 on the EPDS: a)history of depression, b) elevated anxiety or c) couple discord
Who cannot join
- Suicidal ideation or intent
- Physical condition precluding participation in exercise
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Calgary
Calgary, Alberta, T2N1A4
McGill University Health Centre
Montreal, Quebec, H3A 1A1
University of Toronto
Toronto, Ontario, M5T1P8
About this study
Official title: HealthyDads.Ca-Development and Pilot Evaluation of a Multimodal E-Health Intervention to Promote the Mental Health of Men at Risk for Depression
The purpose of this study is to develop and pilot test HealthyDads.ca, a website for expectant first-time fathers who have known risk factors for depression.
- Being tested
- Psychoeducational modules to prevent/reduce depression, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational modules to prevent/reduce depressionBehavioural
Psychoeducational learning modules and tools. Men will choose modules based on interest and need.
Control GroupOther
Continue with standard care.
| Study group | Role | What they receive |
|---|---|---|
| HealthyDads.ca web-based program | Other | An on-line self-help psychoeducational website tailored to new dads. Psychoeducational learning modules and tools, including a 6 week physical activity challenge.. Receives: Behavioral: Psychoeducational modules to prevent/reduce depression |
| Control group | Other | No access to the intervention. Will complete the same questionnaires as the Healthydads.ca group over the study period. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of HealthyDads.caHealthyDads.ca measured by the Usability and Satisfaction questionnaire
To evaluate the acceptability of the internet delivered program in terms of rating on items pertaining to the website's ease of use and satisfaction.
Measured: 6 weeks post randomization
Change from baseline on depressed mood as measured by the Edinburgh Postnatal Depression Scale (EPDS)
This is a widely used reliable and standardized measure of depression.
Measured: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Secondary outcomes (5)
Changes from baseline on emotional well-being as measured by the Mental Health Continuum-Short Form (MHC-SF)
This is a widely used reliable and standardized measure of psychological well-being.
Measured: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on parenting stress measured by the Parenting Stress Scale (PARSS)
This is a widely used reliable and standardized measure of parenting stress.
Measured: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on level of physical activity participation measured by the International Physical Activity Questionnaire (IPAQ)
This is a widely used reliable and standardized measure of physical activity.
Measured: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
This is a widely used reliable and standardized of sleep quality.
Measured: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on perceptions of stigma measured with the Stigma Scale for Receiving Psychological Help (SSRPH),
This is a reliable and standardized measure of stigma perceptions associated with with seeking help for mental health issues.
Measured: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startDec 2015
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health in Expectant First-time FathersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Movember Foundation
- Responsible party
- Principal investigator, Deborah Da Costa, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503670
- Sponsor's protocol ID
- Movember A03-B15-14B
- Status last verified
- Feb 2021
- First submitted
- 17 Jul 2015
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthyDads.Ca-Development and Pilot Evaluation of a Multimodal E-Health Intervention to Promote the Mental Health of Men at Risk for Depression
- ClinicalTrials.gov ID
- NCT02503670
- Acronym / sponsor ID
- Movember A03-B15-14B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Movember Foundation
- Study start
- Dec 2015
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 21 Jul 2015 (estimated)
- 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.
The purpose of this study is to develop and pilot test HealthyDads.ca, a website for expectant first-time fathers who have known risk factors for depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthyDads.ca web-based program | Other | Behavioral: Psychoeducational modules to prevent/reduce depressionAn on-line self-help psychoeducational website tailored to new dads. Psychoeducational learning modules and tools, including a 6 week physical activity challenge.. |
| Control group | Other | Other: Control GroupNo access to the intervention. Will complete the same questionnaires as the Healthydads.ca group over the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to communicate in French or English
- Either married or cohabiting at the time of study entry
- First child for both partners
- Have internet access
- Score <12 on the Edinburgh Postnatal Depression Scale (EPDS)
Key exclusion criteria (2 listed)
- Suicidal ideation or intent
- Physical condition precluding participation in exercise
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 |
|---|---|---|
| Psychoeducational modules to prevent/reduce depressionPsychoeducational learning modules and tools. Men will choose modules based on interest and need. | Behavioural | HealthyDads.ca web-based program |
| Control GroupContinue with standard care. | Other | Control group |
Primary outcome
Acceptability of HealthyDads.caHealthyDads.ca measured by the Usability and Satisfaction questionnaire
Time frame: 6 weeks post randomization
To evaluate the acceptability of the internet delivered program in terms of rating on items pertaining to the website's ease of use and satisfaction.
Change from baseline on depressed mood as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
This is a widely used reliable and standardized measure of depression.
5 secondary outcomes
Changes from baseline on emotional well-being as measured by the Mental Health Continuum-Short Form (MHC-SF)
Time frame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on parenting stress measured by the Parenting Stress Scale (PARSS)
Time frame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on level of physical activity participation measured by the International Physical Activity Questionnaire (IPAQ)
Time frame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Changes from baseline on perceptions of stigma measured with the Stigma Scale for Receiving Psychological Help (SSRPH),
Time frame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational modules to prevent/reduce depression in people with Mental Health in Expectant First-time Fathers, run by McGill University at 3 sites in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of HealthyDads.caHealthyDads.ca measured by the Usability and Satisfaction questionnaire (time frame: 6 weeks post randomization). The study lists 2 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 2 Mar 2021.