Walk With Me (WWM) for Perinatal Grief

Part of paid clinical trials in Eugene, Oregon.

Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
Study ID
NCT07011940
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Along With Me — BEHAVIORAL
    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.
  • Peer Guide — BEHAVIORAL
    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.

Study Details

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)

Key Dates

First listed
Jun 10, 2025
Start date
Jul 13, 2025
Status verified
Jul 2026
Primary completion
Aug 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Services as Usual
    Services as usual received by referral or identified by the participant
  • Experimental: Along With Me Web-Based Intervention
    Web-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.
  • Experimental: Along With Me Web-Based Intervention Plus Peer Guide Support
    Web-based tool plus support from a Peer Guide.

Primary Outcome Measure

PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline, 3,6,9 months post-baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Oregon Research Behavioral Intervention Strategies, Inc.EugeneOregon97477-
Oregon Research Behavioral Strategies, Inc.SpringfieldOregon97477
David R Smith, PhD
[email protected]
541-484-2123

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By specialty
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By research site
Oregon Research Behavioral Intervention Strategies, Inc.· Eugene, OROregon Research Behavioral Strategies, Inc.· Springfield, OR

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