An Intervention Study to Evaluate a Website Tailored to New Dads to Promote Mental Health

Study Overview
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Brief Summary
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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.

Official Title
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HealthyDads.Ca-Development and Pilot Evaluation of a Multimodal E-Health Intervention to Promote the Mental Health of Men at Risk for Depression

Conditions
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Mental Health in Expectant First-time Fathers

Intervention / Treatment
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* Behavioral: Psychoeducational modules to prevent/reduce depression
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HealthyDads.ca web-based program<br>An on-line self-help psychoeducational website tailored to new dads. Psychoeducational learning modules and tools, including a 6 week physical activity challenge.. | Behavioral: Psychoeducational modules to prevent/reduce depression<br>* Psychoeducational learning modules and tools. Men will choose modules based on interest and need.<br>|
| Other: Control group<br>No access to the intervention. Will complete the same questionnaires as the Healthydads.ca group over the study period. | Other: Control Group<br>* Continue with standard care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Study entry, 6 weeks post randomization, 2 and 6 months following delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Study entry, 6 weeks post randomization, 2 and 6 months following delivery |