Recruiting

Parents and Babies

Sponsor:

Northwestern University

Code:

NCT07607613

Conditions

Perinatal Depression

Postpartum Depression (PPD)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Parents and Babies Virtual Group Intervention

Parents and Babies Hybrid Group Intervention

Study Details

Brief summary:

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.

Conditions

Perinatal Depression

Postpartum Depression (PPD)

Study ID

NCT07607613

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • self-identify as LGBTQ+
  • 18 years old or older
  • live in the USA or territories
  • speak and understand English
  • Currently pregnant or within one year of childbirth
  • Endorse current mild depressive symptoms or risk factors for postpartum depression

Exclusion Criteria:

  • Are unable to consent/have impaired decision making capacity
  • Have current active suicidal or homicidal ideation, active psychosis, or current mania
  • Are currently experiencing a severe depressive episode
  • Do not have audio and/or video capacity for attending group sessions remotely.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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 outcome measure

  • Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention) ]
  • Perceived Stress Scale (PSS-10) [ Time Frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention) ]
  • Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention) ]
  • Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention) ]
  • The Acceptability of Intervention Measure (AIM) [ Time Frame: T2 (immediately post-intervention) ]
  • Intervention Appropriateness Measure (IAM) [ Time Frame: T2 (immediately post-intervention) ]
  • Feasibility of Intervention Measure (FIM) [ Time Frame: T2 (immediately post-intervention) ]
  • Implementation of Parents and Babies skills [ Time Frame: T2 (immediately post-intervention), T3 (3-months post-intervention) ]

Central Contacts and Locations

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Leiszle Lapping-Carr

312- 503-3814parentsandbabies@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-06.