Project Portugal 2030

Summary

GENERAL GOAL: to develop and test the efficacy and cost-effectiveness of the Growing Together program, a selective and indicated preventive intervention for pregnant and postpartum women and their partners with identified risk factors for depression/anxiety disorders and/or those already exhibiting early signs of a depression/anxiety disorder and/or high parenting stress. The Growing Together is designed to prevent the development of depression/anxiety disorders and promote a positive mental health in the perinatal period. Additionally, it seeks to prevent the development of high parenting stress and encourage mindful and compassionate parenting practices after birth. Two delivery formats of the intervention will be developed: a fully self-guided online format and a blended online format that combines self-guided sessions with therapist-guided sessions. The intervention consists of two modules: Module 1 (8 sessions during the third trimester of pregnancy) and Module 2 (6 sessions starting in the early postpartum period; Annex 1). Two randomized controlled trials (RCT), each with a 3-arm design, will be conducted to evaluate whether the two delivery formats are more effective in preventing symptoms of perinatal depression/anxiety and parenting stress, and promoting mindful/compassionate parenting compared to the standard care received by women in the perinatal periods (treatment as usual; TAU). One trial (RCT1) will include women who complete Modules 1 and 2; the second trial (RCT2) will include an independent sample of women who only complete Module 2 (Annexes 5-7). SPECIFIC GOALS: 1. To develop the Growing Together program 2. To examine the acceptability and feasibility of Growing Together 3. To examine the efficacy of Growing Together, compared to a TAU control group, in changing the following outcomes (Annexes 3, 8): a. Primary outcomes: Perinatal depression and anxiety symptoms, parenting stress, positive mental health, mindful/compassionate parenting. b. Secondary outcomes: Parent-infant interactions (parental sensitivity and intrusiveness; parent-infant synchrony; parent-infant bonding); obstetric and neonatal outcomes (e.g., pregnancy complications, fetal growth; only in RCT 1); childbirth-related outcomes (e.g., delivery type, birth satisfaction; only in RCT 1); infant outcomes (social-emotional development); impacts on quality of life and consumption of social resources. c. Psychological processes of change: parental reflective functioning, mindfulness, self-compassion, psychological flexibility, emotion regulation. 4. To analyze whether adding human contact through therapist guidance can improve the efficacy of the program, by comparing the two delivery formats. 5. To examine whether completing both modules of the intervention is more effective than only completing Module 2 (i.e., starting the intervention in the postpartum period). 4. To investigate potential predictors and moderators of treatment response to better understand what works best for whom in which circumstances. 5. To identify key factors that may predict adherence to the program. 6. To compare participants participating in the intervention as a couple with those participating alone in primary and secondary outcomes. 7. To examine whether the Growing Together program is cost-effective compared to TAU. 8. To identify barriers and facilitators to the adoption, implementation, and sustainability of Growing Together.