Parents and Babies Pilot Study for Perinatal Depression
This study is testing two versions of the "Parents and Babies" program: a virtual group and a hybrid group. Both are 10-session programs adapted from a well-known intervention for depression during pregnancy and after childbirth (postpartum). The program uses methods like cognitive-behavioral therapy (CBT), which helps you change thinking patterns, and psychoeducation, which teaches you about your condition. We want to see if these programs are practical, acceptable, and if they help improve mental health. You might be able to join if you are 18 or older, identify as LGBTQ+, live in the USA, speak English, are currently pregnant or within one year of childbirth, and have mild depressive symptoms or risk factors for postpartum depression. We will measure your depression, stress, and anxiety levels before, right after, and three months after the program.
- Study design
- This is an interventional pilot study with a planned enrollment of 16 participants. It is testing two different group interventions.
- What's involved
- You would participate in a 10-session intervention. Your mental health will be assessed before, immediately after, and three months following the intervention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your mental health will be followed for three months after the intervention ends.
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Parents and Babies Pilot
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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 skillsT2 (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).