Parents and Babies Pilot
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and…
Conditions studied
Perinatal Depression, Postpartum Depression (PPD)
About this study
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.
Interventions
- Behavioral: Parents and Babies Virtual Group Intervention — Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist.
- Behavioral: Parents and Babies Hybrid Group Intervention — Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation. Sessions are delivered virtually and led by a clinical psychologist, with an option for in-person participation at three sessions.
Primary outcomes
- Patient Health Questionnaire - 9 (PHQ-9) (T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention))
- Perceived Stress Scale (PSS-10) (T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention))
- Generalized Anxiety Disorder Scale (GAD-7) (T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention))
- Multidimensional Scale of Perceived Social Support (MSPSS) (T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention))
- The Acceptability of Intervention Measure (AIM) (T2 (immediately post-intervention))
- Intervention Appropriateness Measure (IAM) (T2 (immediately post-intervention))
- Feasibility of Intervention Measure (FIM) (T2 (immediately post-intervention))
- Implementation of Parents and Babies skills (T2 (immediately post-intervention), T3 (3-months post-intervention))
Eligibility information
Study locations
- Northwestern University, Chicago, Illinois 60611 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.