Walk With Me (WWM) for Perinatal Grief (PeriGrief-II)

Oregon Research Behavioral Intervention Strategies

Status: Begins enrollment in 2 months

Conditions: Infant Death; Suicidal Ideation; Grief; Post Traumatic Stress Disorder; Stillbirth; Miscarriage

Treatments: Behavioral: Along With Me; Behavioral: Peer Guide

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT07011940

2R44MH126788-02 (U.S. NIH Grant/Contract)

MH126788-02

Details and patient eligibility

About

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)

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 3 patient groups

Services as Usual

No Intervention group

Description:

Services as usual received by referral or identified by the participant

Along With Me Web-Based Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Along With Me

Along With Me Web-Based Intervention Plus Peer Guide Support

Experimental group

Description:

Web-based tool plus support from a Peer Guide.

Treatment:

Behavioral: Peer Guide

Behavioral: Along With Me