NCT05110456

To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk

Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: St. Justine's Hospital · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Parents \& Babies intervention to be evaluated is an adaptation of the existing, evidence-based Mothers \& Babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling The Parents \& Babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. Participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team. Participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.

Conditions

• Depression, Postpartum

Interventions

Type	Name	Description
BEHAVIORAL	Telephone support	Participants will receive 10 telephone counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks postpartum. We have included individual telephone calls by a trained coaches aimed to : 1. encourage the use of online material; 2. identify strategies for overcoming obstacles; 3. help apply content to real-life settings; and 4. underscore the participants' success in using effective coping strategies

Timeline

• Start date: 2021-11-09
• Primary completion: 2024-08-30
• Completion: 2024-09-30
• First posted: 2021-11-08
• Last updated: 2026-02-17

Locations

1 site across 1 country: Canada