Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Access to an online cognitive behavioural intervention without telephone support
The control group will receive a fully automated version of the virtual intervention without telephone support
Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support.
The experimental group will receive an online cognitive behavioural intervention with weekly telephone support
干预措施: Telephone support (Behavioral)
结局指标
主要结局
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
时间窗: baseline (between gestational weeks 12-25) , 3 months postpartum
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
次要结局
- Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score(baseline (between gestational weeks 12-25) , 3 and 6 months postpartum)
- Sleep: Pittsburgh Sleep Quality Index (PSQI)(3 months postpartum)
- Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)(baseline (between gestational weeks 12-25))
- Well-being: WHO-5 (World Health Organization) index(3 months postpartum)
- Self-efficacy: General Self-Efficacy scale (GSE)(3 months postpartum)
- Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)(6 months postpartum)
- Stress: Perceived Stress Scale (PSS)(6 months postpartum)
- Self-compassion: Self-Compassion Scale (SCS)(3 months postpartum)
- Social support: Social Provisions(6 months postpartum)
- Parenting practices: Parenting Cognitions and Behaviors Scale(6 months postpartum)
- Child's temperament: Difficult Temperament Scale(6 months postpartum)
- Personality disorders symptoms: Personality Inventory for DSM-5 Brief Form (PID-5 BF)(baseline (between gestational weeks 12-25))
- Social Adjustment: Social Adjustment Scale - Self-report (SAS-SR)(3 months postpartum)
- Marital satisfaction: Short Form of the Dyadic Adjustment Scale (DAS-7)(3 months postpartum)
- 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)(3 and 6 months postpartum)
- Co-parenting: Co-parenting Relationship Scale (CRS)(3 months postpartum)
- Gender roles: Bem Sex Role Inventory (BSRI)(6 months postpartum)
研究者
Sylvana M Côté
Researcher at the research center of the university hospital of saint justine
St. Justine's Hospital