Walk With Me (WWM) for Perinatal Grief
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Along With Me, Peer Guide.
- Who it may be relevant to
- Registry conditions: Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Along With Me
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. - Behavioral Peer Guide
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.
Primary outcome measures
- PTSD Checklist for DSM-5 (PCL-5) [Time frame: Baseline, 3,6,9 months post-baseline]
- Suicide Cognitions Scale (SCS-R) [Time frame: Baseline, 3,6,9 months post-baseline]
- Columiba Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline, 3, 6, and 9 moths post-baseline]
Secondary outcome measures (4)
- Generalized Anxiety Disorder 2-item scale (GAD-2) [Time frame: 3, 6, 9 months post-baseline]
- Patient Health Questionnaire-2 (PHQ-2) [Time frame: 3,6,9 months post-baseline]
- Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool [Time frame: 3,6,9 months post-baseline]
- Perintal Grief Scale (PGS) [Time frame: Baseline, 3, 6, and 9 months post-baseline.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Oregon Research Behavioral Intervention Strategies, Inc. — Eugene
- Oregon Research Behavioral Strategies, Inc. — Springfield
Identifiers
NCT: NCT07011940 · MH126788-02 · 2R44MH126788-02