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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02503670
Enrollment
72
Registered
2015-07-21
Start date
2015-12-31
Completion date
2021-09-30
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health in Expectant First-time Fathers

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.

Interventions

BEHAVIORALPsychoeducational modules to prevent/reduce depression

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

OTHERControl Group

Continue with standard care.

Sponsors

Movember Foundation
CollaboratorOTHER
McGill University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of HealthyDads.caHealthyDads.ca measured by the Usability and Satisfaction questionnaire6 weeks post randomizationTo 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)Study entry, 6 weeks post randomization, 2 and 6 months following deliveryThis is a widely used reliable and standardized measure of depression.

Secondary

MeasureTime frameDescription
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 deliveryThis is a widely used reliable and standardized measure of physical activity.
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 deliveryThis is a widely used reliable and standardized measure of psychological well-being.
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 deliveryThis is a reliable and standardized measure of stigma perceptions associated with with seeking help for mental health issues.
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 deliveryThis is a widely used reliable and standardized of sleep quality.
Changes from baseline on parenting stress measured by the Parenting Stress Scale (PARSS)Study entry, 6 weeks post randomization, 2 and 6 months following deliveryThis is a widely used reliable and standardized measure of parenting stress.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026