16 Participants NeededMy employer runs this trial

Parents and Babies Intervention for Postpartum Depression

(PAB Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help prevent postpartum depression in new or soon-to-be parents. It combines virtual group sessions with some in-person meetings for participants in the Chicago area and fully virtual sessions for those across the U.S. The researchers aim to evaluate the effectiveness and usability of these programs. The trial is open to LGBTQ+ individuals in the U.S. who are pregnant or have given birth within the past year and have mild depression symptoms or risks for postpartum depression. As an unphased study, this trial provides a unique opportunity to contribute to innovative mental health solutions for postpartum depression.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Parents and Babies interventions are safe?

Research has shown that programs like Parents and Babies are generally easy for participants to handle. For instance, the Mothers and Babies Virtual Group, similar to the Parents and Babies Virtual Group, effectively prevents postpartum depression without major side effects. This program uses talk therapy and ideas about building strong parent-child bonds, both of which are safe and improve mental health.

Additionally, studies on programs that combine online and in-person sessions have effectively reduced depression symptoms without causing harm. These methods offer flexibility, making it easier for new parents to join and benefit.

Overall, these group programs are considered safe, with research demonstrating positive results and a very low risk of negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Parents and Babies interventions because they offer innovative delivery methods for addressing postpartum depression. Unlike standard treatments such as medication and in-person therapy, the Hybrid Group Intervention combines virtual sessions with optional in-person meetings, making it accessible yet personal for those in the Chicagoland area. Meanwhile, the Virtual Group Intervention provides flexibility and accessibility to participants across the U.S., allowing for support without geographical constraints. These approaches aim to make mental health care more accessible and adaptable to new parents' varied needs and situations.

What evidence suggests that this trial's interventions could be effective for postpartum depression?

Research shows that the Parents and Babies program uses cognitive-behavioral therapy (CBT) to help change negative thoughts and attachment theory to build strong emotional bonds. Studies have found that this approach can prevent postpartum depression (PPD) by reducing depression symptoms and boosting parenting confidence. This trial will compare two versions of the program: the Hybrid Group, offering virtual sessions with options for in-person attendance in the Chicagoland area, and the Virtual Group, providing virtual sessions for participants across the US. Research on similar programs, such as the Mothers and Babies program, showed effectiveness in lowering the risk of PPD, particularly for high-risk groups like immigrant Latinas. Various studies back the program's success, demonstrating its positive impact in different communities. Overall, evidence suggests that the Parents and Babies program can be a useful tool for preventing PPD.678910

Are You a Good Fit for This Trial?

This trial is for new parents who may be at risk for postpartum depression. Participants should be willing to join group sessions focused on preventing depression after having a baby. Specific inclusion and exclusion criteria are not detailed, but the study targets those in the perinatal period.

Inclusion Criteria

I am 18 years old or older.
Self-identify as LGBTQ+
Live in the USA or territories
See 3 more

Exclusion Criteria

I am currently experiencing a severe depressive episode.
Have current active suicidal or homicidal ideation, active psychosis, or current mania
I am unable to make decisions or give consent for myself.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Parents and Babies perinatal depression prevention intervention, delivered virtually or in a hybrid format

8-12 weeks
Sessions delivered virtually with optional in-person attendance for hybrid group

Follow-up

Participants are monitored for mental health outcomes and intervention effectiveness

3 months
Assessments at T2 (immediately post-intervention) and T3 (3 months post-intervention)

What Are the Treatments Tested in This Trial?

Interventions

  • Parents and Babies Hybrid Group Intervention
  • Parents and Babies Virtual Group Intervention

Trial Overview

The study is testing two versions of a support program called Parents and Babies: one delivered fully online (virtual) and another combining online with some in-person meetings (hybrid). The goal is to see how well these programs help prevent postpartum depression.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Virtual GroupExperimental Treatment1 Intervention
Group II: Hybrid GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Citations

1.

samhsa.gov

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