Walk With Me (WWM) for Perinatal Grief
- Conditions
- GriefPost Traumatic Stress DisorderSuicidal IdeationMiscarriageStillbirthInfant Death
- Registration Number
- NCT07011940
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Within the first month of pregnancy or early infant loss
- Reside in the United State
- Speak and read either English or Spanish at a 6th grade reading level
- 15 or older
- Not pregnant or has not experienced an early infant loss
- Does not reside in the United State
- Does not speak and read either English or Spanish at a 6th grade reading level
- 14 or younger
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method PTSD Checklist for DSM-5 (PCL-5) 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) 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.
- Secondary Outcome Measures
Name Time Method Generalized Anxiety Disorder 7-item scale (GAD-7) 3, 6, 9 months post-baseline 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.
Patient Health Questionnaire-9 (PHQ-9) 3,6,9 months post-baseline 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.
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool 3,6,9 months post-baseline 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.
Intervention Appropriateness Measure (IAM) 3,6,9 months post-baseline The IAM is a brief, pragmatic, and psychometrically validated tool designed to assess stakeholders' perceptions of the appropriateness of an intervention. The measure consists of 4 items, and each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). A mean score is computed, and higher scores indicate greater perceived appropriateness of the intervention.
Acceptability of Intervention Measure (AIM) 3,6,9 months post-baseline The AIM is a brief, pragmatic, and psychometrically validated tool designed to assess stakeholders' perceptions of an intervention's acceptability. The measure consists of 4 items, and each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). A mean score is computed, and higher scores indicate greater perceived acceptability of the intervention.
Related Research Topics
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Trial Locations
- Locations (1)
Oregon Research Behavioral Strategies, Inc.
🇺🇸Springfield, Oregon, United States
Oregon Research Behavioral Strategies, Inc.🇺🇸Springfield, Oregon, United StatesDavid R Smith, PhDContact541-484-2123David.Smith@influentsin.com