Along With Me for Perinatal Grief

(PeriGrief-II Trial)

Overseen By David R Smith, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.

Disqualifiers: Not pregnant, No infant loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a web-based program called Along With Me can reduce stress and suicidal thoughts in parents grieving after losing a pregnancy or infant. It will evaluate whether the program alone, or with additional support from a Peer Guide, is more effective than the usual support provided at hospitals. Participants will use a mobile app with 10 modules to help manage grief. This trial may suit those in the U.S. who have experienced a pregnancy or early infant loss within the past month and can read English or Spanish at a 6th-grade level. As an unphased trial, this study offers a unique opportunity to explore new methods for managing grief and stress.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Along With Me web-based intervention is safe for bereaved parents?

Research has shown that the "Along With Me" online program is designed to assist with posttraumatic stress and suicidal thoughts in individuals who have experienced pregnancy and early infant loss. Studies have found that online tools like this can provide crucial support and information. These tools often employ methods such as cognitive behavioral therapy (a therapy that helps change negative thinking) and mindfulness to aid in managing grief.

A Peer Guide—someone who has undergone a similar experience—can offer additional support. Although specific safety data for this trial is not available, online programs are generally well-received. They are designed to be user-friendly and supportive, without causing medical side effects. The inclusion of a Peer Guide adds emotional support, which many find comforting.

Overall, both the standalone online tool and the version with peer support aim to provide safe and helpful resources for managing grief and mental health challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Along With Me" web-based interventions for perinatal grief because they offer a unique blend of cognitive behavioral therapy and mindfulness strategies delivered online. Unlike traditional therapy sessions that require in-person visits, this web-based tool provides convenient access to therapeutic support through 10 interactive modules. Additionally, the version with Peer Guide support adds a personalized touch, offering guidance from someone who has experienced similar challenges, which isn't typically available in standard care. This innovative approach not only broadens access to mental health resources but also enhances the support system for individuals experiencing perinatal grief.

What evidence suggests that the Along With Me intervention could be effective for reducing posttraumatic stress symptoms and suicidal ideation?

Research has shown that the Along With Me online program, one of the interventions in this trial, uses techniques like cognitive behavioral therapy and mindfulness to help parents who have lost a child cope with their grief. Studies suggest this approach can lower stress related to trauma and improve grief management. Participants in this trial may receive the Along With Me Web-Based Intervention alone or with additional Peer Guide support. Early results also highlight the benefits of online support groups in reducing emotional distress after losing a baby. Additionally, support from peers in the program might further enhance these positive effects. This indicates that the Along With Me program, especially with peer support, could effectively reduce stress and suicidal thoughts in grieving parents. ^{1 2 6 7 8}

Who Is on the Research Team?

David R Smith, PhD

Principal Investigator

Oregon Research Behavioral Intervention Strategies, Inc.

Are You a Good Fit for This Trial?

This trial is for bereaved parents who have experienced pregnancy or early infant loss, such as sudden infant death syndrome, stillbirth, or miscarriage. It aims to help those struggling with post-traumatic stress symptoms and suicidal thoughts.

Inclusion Criteria

Reside in the United States

I can speak and read English or Spanish at a 6th grade level.

I am 15 years old or older.

Exclusion Criteria

I am 14 years old or younger.

Not pregnant or has not experienced an early infant loss

I cannot read or speak English or Spanish at a 6th grade level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including self-report of posttraumatic stress symptoms and suicidal ideation

1 week

Treatment

Participants receive access to the Along With Me app with therapeutic modules and, if applicable, check-ins with a Peer Guide

9 months

Regular app usage and check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3, 6, and 9 months

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Along With Me
• Peer Guide

Trial Overview The trial tests a web-based intervention called Along With Me that includes therapeutic modules on managing grief. Some participants will also receive support from a Peer Guide. The effectiveness of these approaches will be compared to standard hospital referrals.

How Is the Trial Designed?

Group I: Along With Me Web-Based Intervention Plus Peer Guide Support Experimental Treatment 2 Interventions

Web-based tool plus support from a Peer Guide.

Group II: Along With Me Web-Based Intervention Experimental Treatment 1 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 III: Services as Usual Active Control 1 Intervention

Services as usual received by referral or identified by the participant

Who Is Running the Clinical Trial?

Oregon Research Behavioral Intervention Strategies, Inc.

Lead Sponsor

Trials

21

Recruited

8,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11003949

Walk with Me (WWM) for Perinatal Grief This Phase II application proposes to expand and assess the efficacy of a promising digital therapeutic called Along With Me which combines cognitive behavioral ...

2. trial.medpath.com trial.medpath.com/clinical-trial/c1e266d9dbd014b9/nct05318287-walk-with-me-perinatal-grief

Walk With Me for Perinatal Grief - MedPath Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences ...

3. liebertpub.com liebertpub.com/doi/10.1089/cyber.2021.0304

Online Support Groups for Perinatal Loss This study demonstrated feasibility to recruit, retain, and track participation in an online support group for perinatally-bereaved mothers of color.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020748924001263

The impact of midwife/nurse-led psychosocial interventions ... Our findings demonstrate that midwife/nurse-led psychosocial interventions have the potential to improve grief, anxiety, depression, posttraumatic stress ...

5. link.springer.com link.springer.com/article/10.1007/s00404-025-08175-4

a narrative review of physical space in perinatal grief Perinatal loss is a profoundly complex form of grief, often linked to heightened risk of prolonged bereavement and adverse mental health ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451958824001805

The opportunities and challenges of using online social ... Online social platforms can provide important support and information to users that have experienced pregnancy loss.

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06713-7

Experiences and impacts of psychological support following ... Here we report some of the qualitative findings from the evaluation to highlight the experiences and impacts of the FWS on service users. This ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/15325024.2024.2415708

Living with Loss: Evaluating an Internet-Based Program for ... The primary outcome was psychological distress; secondary outcomes were perinatal grief intensity, anxiety, depression, and program satisfaction ...