Walk With Me (WWM) for Perinatal Grief

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)

Conditions

• Grief
• Post Traumatic Stress Disorder
• Suicidal Ideation
• Miscarriage
• Stillbirth
• Infant Death

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Oregon Research Behavioral Intervention Strategies, Inc.

  lead INDUSTRY

Principal Investigators

• David R Smith, PhD · Oregon Research Behavioral Intervention Strategies, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-08-01

Completion

2027-08-31

Countries

• United States

Study Locations