Clinical trial NCT07011940: Walk With Me (WWM) for Perinatal Grief
Official title: Walk With Me (WWM) for Perinatal Grief
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Grief
Post Traumatic Stress Disorder
Suicidal Ideation
Miscarriage
Stillbirth
Infant Death
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-06-10
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 3,6,9 months post-baseline
measure: Suicide Cognitions Scale (SCS-R)
timeFrame: 3,6,9 months post-baseline
Secondary outcomes:
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 3, 6, 9 months post-baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3,6,9 months post-baseline
measure: Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool
timeFrame: 3,6,9 months post-baseline
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 3,6,9 months post-baseline
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 3,6,9 months post-baseline
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Behavioral Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
name: David R Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: