Recruiting

Along With Me & Peer Guide

Sponsor:

Oregon Research Behavioral Intervention Strategies, Inc.

Code:

NCT07011940

Conditions

Grief

Post Traumatic Stress Disorder

Suicidal Ideation

Miscarriage

Stillbirth

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

Interventions

Along With Me

Peer Guide

Study Details

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)

Conditions

Grief

Post Traumatic Stress Disorder

Suicidal Ideation

Miscarriage

Stillbirth

Study ID

NCT07011940

Start date

Jul 13, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

David R Smith, PhD

541-484-2123david.smith@influentsin.com

Camille Cioffi, PhD

541-484-2123camille.cioffi@influentsin.com

Locations

Oregon Research Behavioral Intervention Strategies, Inc.

Recruiting

Eugene, Oregon, United States, 97477

More Information

Sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Research Behavioral Intervention Strategies, Inc. on 2026-07-15.