GriefPeriGrief-IINCT07011940
Walk With Me (WWM) for Perinatal Grief
A study testing Along With Me and Peer Guide in people with Grief and Post Traumatic Stress Disorder, run by Oregon Research Behavioral Intervention Strategies, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief, Post Traumatic Stress Disorder, Suicidal Ideation
- What is being tested?
- Along With Me and Peer Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Oregon Research Behavioral Intervention Strategies, Inc.
Eugene, Oregon, 97477
- Not yet recruiting
Oregon Research Behavioral Strategies, Inc.
Springfield, Oregon, 97477
David R Smith, PhD, 541-484-2123, David.Smith@influentsin.com
About this study
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:
Read more
- 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)
Read the 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.
- Conditions
- Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage, Stillbirth, Infant Death
- Being tested
- Along With Me, Peer Guide
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicidal Ideation, Abortion, Spontaneous, Stillbirth, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Along With MeBehavioural
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 GuideBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Services as Usual | No intervention | Services as usual received by referral or identified by the participant |
| Along With Me Web-Based Intervention | Experimental | 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. Receives: Behavioral: Along With Me |
| Along With Me Web-Based Intervention Plus Peer Guide Support | Experimental | Web-based tool plus support from a Peer Guide. Receives: Behavioral: Along With Me; Behavioral: Peer Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
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.
Measured: Baseline, 3,6,9 months post-baseline
Suicide Cognitions Scale (SCS-R)
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.
Measured: Baseline, 3,6,9 months post-baseline
Columiba Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Baseline, 3, 6, and 9 moths post-baseline
Secondary outcomes (4)
Generalized Anxiety Disorder 2-item scale (GAD-2)
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.
Measured: 3, 6, 9 months post-baseline
Patient Health Questionnaire-2 (PHQ-2)
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.
Measured: 3,6,9 months post-baseline
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool
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.
Measured: 3,6,9 months post-baseline
Perintal Grief Scale (PGS)
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.
Measured: Baseline, 3, 6, and 9 months post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start13 Jul 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- David R Smith, PhD, Principal investigator, Oregon Research Behavioral Intervention Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011940
- Sponsor's protocol ID
- MH126788-02
- Other IDs
- 2R44MH126788-02
- Acronym
- PeriGrief-II
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be accessible through openICPSR's Search function by topic (e.g., maternal health). Other researchers will be able to see a study description and a link to download data and documentation files. openICPSR provides a DOI number for each data upload such that published study results will be linked to the exact data used and allows depositors to update data files and metadata at any time. Survey Data: De-identified individual and aggregate survey data (raw and recoded) will be shared. The de-identification process will remove direct and indirect respondent identifiers. Once data are confirmed final, respondent identifiers will be deleted.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk With Me (WWM) for Perinatal Grief
- ClinicalTrials.gov ID
- NCT07011940
- Acronym / sponsor ID
- PeriGrief-II / MH126788-02
- Conditions
- Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage, Stillbirth, Infant Death
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Services as Usual | No intervention | –Services as usual received by referral or identified by the participant |
| Along With Me Web-Based Intervention | Experimental | Behavioral: Along With MeWeb-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. |
| Along With Me Web-Based Intervention Plus Peer Guide Support | Experimental | Behavioral: Along With Me, Behavioral: Peer GuideWeb-based tool plus support from a Peer Guide. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Along With MeAlong 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. | Behavioural | Along With Me Web-Based Intervention, Along With Me Web-Based Intervention Plus Peer Guide Support |
| Peer GuideThe peer guide will provide light touch reminders, opportunities to debrief, and resource navigation support, similar to community health navigator interventions provided remotely through insurers. | Behavioural | Along With Me Web-Based Intervention Plus Peer Guide Support |
Primary outcome
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.
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.
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.
4 secondary outcomes
Generalized Anxiety Disorder 2-item scale (GAD-2)
Time frame: 3, 6, 9 months post-baseline
Patient Health Questionnaire-2 (PHQ-2)
Time frame: 3,6,9 months post-baseline
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool
Time frame: 3,6,9 months post-baseline
Perintal Grief Scale (PGS)
Time frame: Baseline, 3, 6, and 9 months post-baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. Study data will be accessible through openICPSR's Search function by topic (e.g., maternal health). Other researchers will be able to see a study description and a link to download data and documentation files. openICPSR provides a DOI number for each data upload such that published study results will be linked to the exact data used and allows depositors to update data files and metadata at any time. Survey Data: De-identified individual and aggregate survey data (raw and recoded) will be shared. The de-identification process will remove direct and indirect respondent identifiers. Once data are confirmed final, respondent identifiers will be deleted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David R Smith, PhD principal investigator
Oregon Research Behavioral Intervention Strategies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Along With Me and Peer Guide in people with Grief and Post Traumatic Stress Disorder, run by Oregon Research Behavioral Intervention Strategies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David R Smith, PhD (541-484-2123, david.smith@influentsin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Baseline, 3,6,9 months post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.