Walk With Me (WWM) for Perinatal Grief

NCT ID: NCT07011940

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Grief Post Traumatic Stress Disorder Suicidal Ideation Miscarriage Stillbirth Infant Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Services as Usual

Services as usual received by referral or identified by the participant

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Along With Me

Intervention Type 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.

Along With Me Web-Based Intervention Plus Peer Guide Support

Web-based tool plus support from a Peer Guide.

Group Type EXPERIMENTAL

Along With Me

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David R Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Behavioral Intervention Strategies, Inc.

Locations

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Oregon Research Behavioral Strategies, Inc.

Springfield, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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David R Smith, PhD

Role: CONTACT

541-484-2123

Camille Cioffi, PhD

Role: CONTACT

541-484-2123

Facility Contacts

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David R Smith, PhD

Role: primary

541-484-2123

Other Identifiers

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2R44MH126788-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH126788-02

Identifier Type: -

Identifier Source: org_study_id