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

NCT02503670 | Unknown

• 1 other identifier: Movember A03-B15-14B
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Mental Health in Expectant First-time Fathers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Changes from baseline on emotional well-being as measured by the Mental Health Continuum-Short Form (MHC-SF)

  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)

  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)

  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)

  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),

  Study entry, 6 weeks post randomization, 2 and 6 months following delivery

Study Arms (2)

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..

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.

Other: Control Group

Interventions

Psychoeducational modules to prevent/reduce depression BEHAVIORAL

Psychoeducational learning modules and tools. Men will choose modules based on interest and need.

HealthyDads.ca web-based program

Control Group OTHER

Continue with standard care.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead
• Movember Foundation: collaborator

Study Sites (3)

University of Calgary

Calgary, Alberta, T2N1A4, Canada

Location

University of Toronto

Toronto, Ontario, M5T1P8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: December 1, 2015
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

CA (3)