Walk With Me for Perinatal Grief
This study, called "Walk With Me (WWM)," is testing a therapeutic app called "Along With Me" and the support of a "Peer Guide" for parents experiencing grief after pregnancy or early infant loss. The app uses cognitive behavior therapy (CBT) and mindfulness to help with grief and trauma symptoms. The Peer Guide offers reminders and support. The study wants to see if these interventions can lower post-traumatic stress disorder (PTSD) symptoms and suicidal thoughts. You might be able to join if you are at least 15 years old, live in the United States, and have experienced pregnancy or early infant loss within the last month. The study aims to enroll 300 participants.
- Study design
- This is a randomized study with 300 participants divided into three groups: one receiving usual care, one receiving the Along With Me app, and one receiving the app plus a Peer Guide.
- What's involved
- You would complete a baseline assessment and then additional assessments at 3, 6, and 9 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 9 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Walk With Me (WWM) for Perinatal Grief
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- David R Smith, PhD · PRINCIPAL_INVESTIGATOR · Oregon Research Behavioral Intervention Strategies, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- PTSD Checklist for DSM-5 (PCL-5)Baseline, 3,6,9 months post-baseline
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.
- Suicide Cognitions Scale (SCS-R)Baseline, 3,6,9 months post-baseline
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.
- Columiba Suicide Severity Rating Scale (C-SSRS)Baseline, 3, 6, and 9 moths post-baseline
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.