Perinatal Depression, Postpartum Depression (PPD)
Conditions
Brief summary
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.
Interventions
BEHAVIORALParents 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.
BEHAVIORALParents 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.
Sponsors
Northwestern University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be recruited for two groups, with a maximum of eight participants per group. Only participants in the Chicagoland area will be eligible for the hybrid group; participants from across the US will be eligible for the virtual-only group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 9 (PHQ-9) | 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. |
| Perceived Stress Scale (PSS-10) | 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. |
| Generalized Anxiety Disorder Scale (GAD-7) | 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. |
| Multidimensional Scale of Perceived Social Support (MSPSS) | 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. |
| The Acceptability of Intervention Measure (AIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
| Feasibility of Intervention Measure (FIM) | 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. |
| Implementation of Parents and Babies skills | 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). |
Countries
United States
Outcome results
None listed