Anxiety & Depression Association of America

Parents and Babies Pilot

Purpose

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)

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be recruited for two groups, with a maximum of eight participants per group. Only participants in the Chicagoland area will be eligible for the hybrid group; participants from across the US will be eligible for the virtual-only group.
Primary Purpose: Prevention
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Virtual Group	Sessions will be delivered virtually. Includes participants from across the US.	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.
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.	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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Northwestern University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.