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

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.

Study Overview

• Status: Unknown
• Conditions: Mental Health in Expectant First-time Fathers
• Intervention / Treatment: Behavioral: Psychoeducational modules to prevent/reduce depression; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N1A4
      • University of Calgary
  • Ontario
    • Toronto, Ontario, Canada, M5T1P8
      • University of Toronto
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HealthyDads.ca web-based program; 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; Psychoeducational learning modules and tools. Men will choose modules based on interest and need.
Other: Control group; No access to the intervention. Will complete the same questionnaires as the Healthydads.ca group over the study period.	Other: Control Group; Continue with standard care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Movember Foundation

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Movember A03-B15-14B