Clinical trial NCT05110456: To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
Official title: Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Hewitt Foundation
First posted: 2021-11-08
Enrollment: 510
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
timeFrame: baseline (between gestational weeks 12-25) , 3 months postpartum
Secondary outcomes:
measure: Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 months postpartum
measure: Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score
timeFrame: baseline (between gestational weeks 12-25) , 3 and 6 months postpartum
measure: Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)
timeFrame: baseline (between gestational weeks 12-25)
measure: Stress: Perceived Stress Scale (PSS)
timeFrame: 6 months postpartum
measure: Well-being: WHO-5 (World Health Organization) index
timeFrame: 3 months postpartum
measure: Self-efficacy: General Self-Efficacy scale (GSE)
timeFrame: 3 months postpartum
measure: Self-compassion: Self-Compassion Scale (SCS)
timeFrame: 3 months postpartum
measure: Sleep: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months postpartum
measure: Social Adjustment: Social Adjustment Scale - Self-report (SAS-SR)
timeFrame: 3 months postpartum
measure: Marital satisfaction: Short Form of the Dyadic Adjustment Scale (DAS-7)
timeFrame: 3 months postpartum
measure: Co-parenting: Co-parenting Relationship Scale (CRS)
timeFrame: 3 months postpartum
measure: Social support: Social Provisions
timeFrame: 6 months postpartum
measure: Parenting practices: Parenting Cognitions and Behaviors Scale
timeFrame: 6 months postpartum
measure: Change from 3 months post-partum at 6 month post partum child social, emotional and cognitive development: Ages and stages questionnaire 3rd edition (ASQ-3)
timeFrame: 3 and 6 months postpartum
measure: Child's temperament: Difficult Temperament Scale
timeFrame: 6 months postpartum
measure: Personality disorders symptoms: Personality Inventory for DSM-5 Brief Form (PID-5 BF)
timeFrame: baseline (between gestational weeks 12-25)
measure: Gender roles: Bem Sex Role Inventory (BSRI)
timeFrame: 6 months postpartum
Other outcomes:
measure: Health Service Utilization and Cost of Care Questionnaire
timeFrame: 6 months postpartum
Locations:
city: Montréal
country: Canada
facility: St. Justine hospital
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Sylvana Côté
role: PRINCIPAL_INVESTIGATOR
References: