Parents and Babies Pilot (PAB)
3. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
16
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
Illinois
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Chicago, Illinois, Vereinigte Staaten, 60611
- Rekrutierung
- Northwestern University
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Kontakt:
- Leiszle Lapping-Carr
- Telefonnummer: 312- 503-3814
- E-Mail: parentsandbabies@northwestern.edu
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Virtual Group
Sessions will be delivered virtually.
Includes participants from across the US.
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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.
|
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Implementation of Parents and Babies skills
Zeitfenster: T2 (immediately post-intervention), T3 (3-months post-intervention)
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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).
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T2 (immediately post-intervention), T3 (3-months post-intervention)
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Patient Health Questionnaire - 9 (PHQ-9)
Zeitfenster: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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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.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
|
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Perceived Stress Scale (PSS-10)
Zeitfenster: 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.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Generalized Anxiety Disorder Scale (GAD-7)
Zeitfenster: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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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.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Multidimensional Scale of Perceived Social Support (MSPSS)
Zeitfenster: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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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.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Acceptability of Intervention Measure (AIM)
Zeitfenster: T2 (immediately post-intervention)
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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.
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T2 (immediately post-intervention)
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Intervention Appropriateness Measure (IAM)
Zeitfenster: T2 (immediately post-intervention)
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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.
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T2 (immediately post-intervention)
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Feasibility of Intervention Measure (FIM)
Zeitfenster: T2 (immediately post-intervention)
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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.
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T2 (immediately post-intervention)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
3. August 2026
Primärer Abschluss (Geschätzt)
1. April 2027
Studienabschluss (Geschätzt)
1. April 2027
Studienanmeldedaten
Zuerst eingereicht
19. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Mai 2026
Zuerst gepostet (Tatsächlich)
26. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU00225523
- 5K23MD018092-03 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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UNENTSCHIEDEN
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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