Parents and Babies Pilot

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07607613
Status
Not Yet Recruiting

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Conditions

  • Perinatal Depression
  • Postpartum Depression (PPD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Parents and Babies Virtual Group Intervention — BEHAVIORAL
    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.
  • Parents and Babies Hybrid Group Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Virtual Group
    Sessions will be delivered virtually. Includes participants from across the US.
  • Experimental: Hybrid Group
    Sessions will be delivered virtually with three hybrid sessions with options for in-person attendance. Includes only participants located in the Chicagoland area.

Primary Outcome Measure

Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Leiszle Lapping-Carr
[email protected]
312- 503-3814

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By research site
Northwestern University· Chicago, IL

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