Walk With Me (WWM) for Perinatal Grief
PeriGrief-II
2 other identifiers
interventional
300
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 31, 2027
March 6, 2026
March 1, 2026
1.1 years
June 2, 2025
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Baseline, 3, 6, and 9 moths post-baseline
Secondary Outcomes (4)
Generalized Anxiety Disorder 7-item scale (GAD-7)
3, 6, 9 months post-baseline
Patient Health Questionnaire-9 (PHQ-9)
3,6,9 months post-baseline
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool
3,6,9 months post-baseline
Perintal Grief Scale (PGS)
Baseline, 3, 6, and 9 months post-baseline.
Study Arms (3)
Services as Usual
NO INTERVENTIONServices as usual received by referral or identified by the participant
Along With Me Web-Based Intervention
EXPERIMENTALWeb-based tool that offers therapeutic support modules with information that leverages cognitive behavioral therapy and mindfulness strategies. The web-based tool includes 10 modules and also includes a list of resources and journaling feature.
Along With Me Web-Based Intervention Plus Peer Guide Support
EXPERIMENTALWeb-based tool plus support from a Peer Guide.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- or older
You may not qualify if:
- 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
- or younger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Research Behavioral Strategies, Inc.
Springfield, Oregon, 97477, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R Smith, PhD
Oregon Research Behavioral Intervention Strategies, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2025
First Posted
June 10, 2025
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Project data and documentation will be uploaded into openICPSR at the time of initial publication, or by the end of the research project period, whichever occurs first. If publication occurs prior to the project's end, researchers will utilize the version update DOI process to maintain data sharing transparency for published study results and supporting data. A complete, deidentified project data set and all supporting documentation will resided on openICPSR as the final data version when the project concludes. Researchers anticipate having project data available in openICPSR for 5 years after the project ends.
- Access Criteria
- To meet data sharing requirement for our study data and documentation, we have selected the openICPSR repository.
Study data will be accessible through openICPSR's Search function by topic (e.g., maternal health). Other researchers will be able to see a study description and a link to download data and documentation files. openICPSR provides a DOI number for each data upload such that published study results will be linked to the exact data used and allows depositors to update data files and metadata at any time. Survey Data: De-identified individual and aggregate survey data (raw and recoded) will be shared. The de-identification process will remove direct and indirect respondent identifiers. Once data are confirmed final, respondent identifiers will be deleted.