Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07011940

Walk With Me (WWM) for Perinatal Grief

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)

Recruiting

Interested in participating?

Request Info

Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Behavioral Intervention Strategies, Inc., Eugene, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: Baseline, 3,6,9 months post-baseline

    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.

  2. Suicide Cognitions Scale (SCS-R)

    Time frame: Baseline, 3,6,9 months post-baseline

    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.

  3. Columiba Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline, 3, 6, and 9 moths post-baseline

    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.

Secondary outcomes

  1. Generalized Anxiety Disorder 2-item scale (GAD-2)

    Time frame: 3, 6, 9 months post-baseline

    The GAD-2 is a brief screening tool for generalized anxiety disorder, made up of the first two items of the longer GAD-7. It's designed as a fast, first-pass screen for anxiety in primary care and research settings. Respondents rate how often they've been bothered by each symptom over the past two weeks using a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total sum score ranges from 0 to 6, with higher scores indicating greater severity of anxiety symptoms.

  2. Patient Health Questionnaire-2 (PHQ-2)

    Time frame: 3,6,9 months post-baseline

    The PHQ-2 is a brief screening tool for depression, made up of the first two items of the longer PHQ--9. It's designed as a fast, first-pass screen for anxiety in primary care and research settings. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total sum score ranges from 0 to 3, with higher scores indicating greater severity of depression.

  3. Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool

    Time frame: 3,6,9 months post-baseline

    The TAPS Tool is a brief assessment instrument designed to identify problematic substance use and substance use disorders, consisting of 3-4 items per substance class, evaluating past 3-month usage (=1), problems related to use (=1), and concerns expressed by others (=1). Score for alcohol can range from 0-4, and other substances from 0-3. Scores greater than 1 indicate problematic use, and scores greater than 2 indicate a potential substance use disorder.

  4. Perintal Grief Scale (PGS)

    Time frame: Baseline, 3, 6, and 9 months post-baseline.

    The Perinatal Grief Scale (PGS) is a 33-item brief version was developed to quantify grief reactions following perinatal loss, including losses due to spontaneous abortion, fetal or neonatal death, or ectopic pregnancy. Response options are on a 5-point Likert-type scale (1 = strongly agree, 5 = strongly disagree). All but two items (item 11 and 33) are reveresed scored and three grief subdomain sum scores created: Active Grief (11items), Difficulty Coping (11 items), and Despair (11 items). Subdomain scores can range from 11 to 55 with higher scores indicating higher levels of grief.

Study contacts

Contact information is provided by the study sponsor or research team.

Camille Cioffi, PhD

CONTACT

[email protected]

541-484-2123

David R Smith, PhD

CONTACT

[email protected]

541-484-2123

Sponsors and collaborators

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Industry

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: PeriGrief-II

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.