Clinical trial NCT02503670: An Intervention Study to Evaluate a Website Tailored to New Dads to Promote Mental Health
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health in Expectant First-time Fathers
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Movember Foundation
First posted: 2015-07-21
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Suicidal ideation or intent
* Physical condition precluding participation in exercise

Primary outcomes:
measure: Acceptability of HealthyDads.caHealthyDads.ca measured by the Usability and Satisfaction questionnaire
timeFrame: 6 weeks post randomization
measure: Change from baseline on depressed mood as measured by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Secondary outcomes:
measure: Changes from baseline on emotional well-being as measured by the Mental Health Continuum-Short Form (MHC-SF)
timeFrame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
measure: Changes from baseline on parenting stress measured by the Parenting Stress Scale (PARSS)
timeFrame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
measure: Changes from baseline on level of physical activity participation measured by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
measure: Changes from baseline on sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
measure: Changes from baseline on perceptions of stigma measured with the Stigma Scale for Receiving Psychological Help (SSRPH),
timeFrame: Study entry, 6 weeks post randomization, 2 and 6 months following delivery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: