Parents and Babies Pilot (PAB)
3 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
16
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Rekrytering
- Northwestern University
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Kontakt:
- Leiszle Lapping-Carr
- Telefonnummer: 312- 503-3814
- E-post: parentsandbabies@northwestern.edu
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Implementation of Parents and Babies skills
Tidsram: 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)
Tidsram: 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)
Tidsram: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 augusti 2026
Primärt slutförande (Beräknad)
1 april 2027
Avslutad studie (Beräknad)
1 april 2027
Studieregistreringsdatum
Först inskickad
19 maj 2026
Först inskickad som uppfyllde QC-kriterierna
19 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STU00225523
- 5K23MD018092-03 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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