To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postp… (NCT05110456) | Clinical Trial Compass
CompletedNot Applicable
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
Canada510 participantsStarted 2021-11-09
Plain-language summary
Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents \& Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents \& Babies program offered with telephone support compared to the course offered without telephone follow-up.
Who can participate
Age range
14 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women (12-25 weeks' gestation)
* subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
* ability to read and understand French.
Exclusion Criteria:
* EPDS score in the clinical range (≥ 17) or no symptoms (EPDS \< 8)
* Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
* self-reported substance abuse problems.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)