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Parents and Babies Pilot (PAB)

1. juni 2026 opdateret af: Leiszle Rae Lapping-Carr, Northwestern University

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Virtual Group
Sessions will be delivered virtually. Includes participants from across the US.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implementation of Parents and Babies skills
Tidsramme: T2 (immediately post-intervention), T3 (3-months post-intervention)
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)
Patient Health Questionnaire - 9 (PHQ-9)
Tidsramme: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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)
Tidsramme: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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)
Tidsramme: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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)
Tidsramme: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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)
Tidsramme: T2 (immediately post-intervention)
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)
Tidsramme: T2 (immediately post-intervention)
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)
Tidsramme: T2 (immediately post-intervention)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Samarbejdspartnere

National Institute on Minority Health and Health Disparities (NIMHD)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU00225523
  • 5K23MD018092-03 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Perinatal depression

Kliniske forsøg med Parents and Babies Virtual Group Intervention

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