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Recruiting NCT07607613

Parents and Babies Pilot

No phase Interventional Perinatal Depression Postpartum Depression (PPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parents and Babies Virtual Group Intervention, Parents and Babies Hybrid Group Intervention.
Who it may be relevant to
Registry conditions: Perinatal Depression, Postpartum Depression (PPD). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention

Overview

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 outcome measures

  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT07607613 · STU00225523 · 5K23MD018092-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗