Parents and Babies Pilot

NCT07607613 | Not Yet Recruiting

• 2 other identifiers: STU002255235K23MD018092-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Postpartum Depression (PPD); Perinatal Depression

Outcome Measures

Primary Outcomes (8)

• Patient Health Questionnaire - 9 (PHQ-9)

  The Patient Health Questionnaire-9 is the 9 item depression module of the Patient Health Questionnaire. It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher scores indicate an increased severity of depression symptoms.

  T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)

• Perceived Stress Scale (PSS-10)

  The Perceived Stress Scale (PSS-10; Cohen, Kamarch, \& Mermelstein,1983) is a 10 item measure of the degree to which situations in one's life are appraised as stressful with responses rated on a 5-point Likert scale (0 =never to 4 =very often). Higher scores indicate greater perceived stress.

  T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)

• Generalized Anxiety Disorder Scale (GAD-7)

  The Generalized Anxiety Disorder Scale (Spitzer et.al, 2006) is a 7 item self-report measure used to assess anxiety. Participants are queried regarding symptoms during the past two weeks and responses are tallied on a four-point Likert scale. (0 = not at all to 3=nearly every day.) Higher scores indicate an increased severity of anxiety symptoms.

  T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)

• Multidimensional Scale of Perceived Social Support (MSPSS)

  The Multidimensional Scale of Perceived Social Support (Zimet et al. 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). Higher scores in each subscale indicate greater perceived support from that source.

  T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)

• The Acceptability of Intervention Measure (AIM)

  The Acceptability of Intervention Measure (Weiner et al., 2017) is a four-item measure of implementation outcomes to determine the extent to which one believes an intervention is appealing and satisfactory on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived acceptability of the intervention.

  T2 (immediately post-intervention)

• Intervention Appropriateness Measure (IAM)

  Intervention Appropriateness Measure (Weiner et al., 2017) is a four-item measure evaluating the extent to which one believes an intervention is suitable, relevant, compatible, and applicable to one's needs on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived appropriateness of the intervention.

  T2 (immediately post-intervention)

• Feasibility of Intervention Measure (FIM)

  Feasibility of Intervention Measure (Weiner et al., 2017) is a four-item survey measuring the perceived feasibility of an intervention on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Higher scores indicate greater perceived feasibility of the intervention.

  T2 (immediately post-intervention)

• Implementation of Parents and Babies skills

  Parents and Babies Skill Utilization Survey - 8 item questionnaire to determine the extent to which one agrees that the PAB course taught skills related to the core modules, was useful, and was easy to understand; using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).

  T2 (immediately post-intervention), T3 (3-months post-intervention)

Study Arms (2)

Virtual Group

EXPERIMENTAL

Sessions will be delivered virtually. Includes participants from across the US.

Behavioral: Parents and Babies Virtual Group Intervention

Hybrid Group

EXPERIMENTAL

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

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.

Virtual Group

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.

Hybrid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as LGBTQ+
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

US (1)