Northwestern University
Chicago, Illinois, 60611, United States
NCT Number: NCT07607613
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Northwestern University
Other
Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention
Acronym: PAB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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