The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes. The main questions it aims to answer are: • Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation. Participants will: * Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * Receive check-ins with a Peer Guide (in the Peer Guide condition only)
Our clinical trial is a randomized, three-group controlled trial in which 300 bereaved parents who have experienced pregnancy or early infant loss will be randomly assigned to control (Group 1: treatment as usual, n = 100), Along With Me only (Group 2, n = 100), or the Along With Me Plus Peer Guide (Group 3, n = 100). Participants will be recruited prior to randomization and assigned to condition after consent. Bereaved parents in the treatment arms will receive access to the Along With Me app that provides psychoeducation on grief, and Cognitive Behavioral Therapy (CBT) and Mindfulness skills to manage grief and reduce the risk of posttraumatic stress following pregnancy loss. All participants will complete a baseline assessment that includes self-report of posttraumatic stress symptoms and suicidal ideation, and secondary measures pertaining to mental health symptoms, substance use, coping, grief self-efficacy, and for those in the treatment condition, acceptability and usability for the Along With Me app. Additional assessments will occur at 3 months, 6 months, and 9 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Along With Me is a therapeutic app that delivers cognitive behavior therapy and mindfulness-based psychoeducation and skills, grief normalization, and exercises to address perinatal grief and to reduce trauma symptoms related to the experience of perinatal loss. The Along With Me only arm will deliver the app-based intervention only.
The peer guide will provide light touch reminders, opportunities to debrief, and resource navigation support, similar to community health navigator interventions provided remotely through insurers.
Oregon Research Behavioral Strategies, Inc.
Springfield, Oregon, United States
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a widely used self-report measure for assessing PTSD symptoms based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria (DSM-5). There are 20 self-report items, and each item is rated on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"). A sum score is computed and can range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Time frame: Baseline, 3,6,9 months post-baseline
Suicide Cognitions Scale (SCS-R)
The SCS-R is a 16-item self-report measure designed to assess suicidogenic cognitions-beliefs and perceptions that increase vulnerability to suicidal behavior. The response option utilizes a 0-4 Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree). A sum score is computed, resulting in a total score range of 0 to 64. Higher scores indicate stronger endorsement of maladaptive cognitions associated with suicide risk.
Time frame: Baseline, 3,6,9 months post-baseline
Columiba Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a 6-item structured set of questions used to assess suicidal ideation (5 items listed from least to most severe) and suicidal behavior (1 item). It is designed to help determine whether suicide-related thoughts/behaviors are present, and if so, their severity and clinical urgency, using standardized definitions and prompts. Response options are on a "yes" and "no" format. Clinically, you use the highest ideation category endorsed (1-5) as the ideation severity indicator and higher scores indicate greater levels of suicidal ideation. The suidial behavior item is a stand alone item indicating presense (=yes) or absence (=no) of any suicidal behavior.
Time frame: Baseline, 3, 6, and 9 moths post-baseline
Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is a 7-item self-report questionnaire designed to screen for and assess the severity of generalized anxiety disorder (GAD). Each item corresponds to one of the core symptoms of GAD as outlined in the DSM-IV. Respondents rate how often they've been bothered by each symptom over the past two weeks using a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total sum score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Time frame: 3, 6, 9 months post-baseline
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-administered tool designed to screen for and measure the severity of depression. It consists of 9 items, each corresponding to one of the DSM-IV criteria for major depressive disorder. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total sum score ranges from 0 to 27, with higher scores indicating greater severity of depression.
Time frame: 3,6,9 months post-baseline
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool
The TAPS Tool is a brief assessment instrument designed to identify problematic substance use and substance use disorders, consisting of 3-4 items per substance class, evaluating past 3-month usage (=1), problems related to use (=1), and concerns expressed by others (=1). Score for alcohol can range from 0-4, and other substances from 0-3. Scores greater than 1 indicate problematic use, and scores greater than 2 indicate a potential substance use disorder.
Time frame: 3,6,9 months post-baseline
Perintal Grief Scale (PGS)
The Perinatal Grief Scale (PGS) is a 33-item brief version was developed to quantify grief reactions following perinatal loss, including losses due to spontaneous abortion, fetal or neonatal death, or ectopic pregnancy. Response options are on a 5-point Likert-type scale (1 = strongly agree, 5 = strongly disagree). All but two items (item 11 and 33) are reveresed scored and three grief subdomain sum scores created: Active Grief (11items), Difficulty Coping (11 items), and Despair (11 items). Subdomain scores can range from 11 to 55 with higher scores indicating higher levels of grief.
Time frame: Baseline, 3, 6, and 9 months post-baseline.
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