Parents and Babies Pilot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
self-identify as LGBTQ+
18 years old or older
live in the USA or territories
speak and understand English
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Parents and Babies Virtual Group Intervention
BehavioralParents 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.
Parents and Babies Hybrid Group Intervention
BehavioralParents 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Virtual GroupExperimental treatment 1 intervention
Group B: Hybrid GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)2
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.
Time frame
T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)3
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.
Time frame
T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)4
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.
Time frame
T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov