GriefPeriGriefNCT05318287
Walk With Me for Perinatal Grief
A study testing Walk with Me in people with Grief and Traumatic Stress, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site in United States.
Trial summary
This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief, Traumatic Stress, Usability
- What is being tested?
- Walk with Me
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Research Behavioral Intervention Strategies, Inc.
Springfield, Oregon, 97477
About this study
Official title: Walk With Me (WWM) for Perinatal Grief
This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process.
Read the detailed description
The investigators will develop grief processing and healing activities for bereaved parents, via an iterative formative development process with stakeholder input. The investigators will embed the core intervention components in administrative, provider, and client interfaces which will comprise the prototype Walk with Me (WWM) intervention.
The investigators will evaluate its feasibility and initial efficacy of WWM in a within-subjects pre-post design study. The investigators will provide the mobile-based provider component for use by health care professionals (HCPs) who work in the partner hospital. HCPs will have access to training videos and bereaved parent content. After training, the HCPs will recruit 52 bereaved parents.
HCPs will obtain consent from bereaved parents who express interest in the study to share their contact information with the research team. Parents who wish to participate will provide consent for their own participation in the study. After consent, parents will complete the baseline survey via the Qualtrics online assessment form and then be provided download access to the WWM prototype. At 4 and 8 weeks, parents will be administered post-treatment surveys. This design will allow the investigators to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of the prototype WWM program.
Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences. The post-survey questionnaire will contain measures of usability, as well as any difficulties experienced or problems made worse. Demographics will be collected at the baseline assessment. Project staff will follow-up with parents as needed to encourage survey completion in a timely manner.
- Conditions
- Grief, Traumatic Stress, Usability
- Being tested
- Walk with Me
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk with MeBehavioural
Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving.
| Study group | Role | What they receive |
|---|---|---|
| PeriGrief | Experimental | A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. Receives: Behavioral: Walk with Me |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traumatic Stress - Intrusion Subscale
Impact of Event Scale-Revised (IES-R) includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Traumatic Stress - Avoidance Subscale
Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Traumatic Stress - Hyperarousal Subscale
Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Grief Intensity - Reality Subscale
The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Grief Intensity - Congruence Subscale
The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Grief Intensity - Ability to Confront Others Subscale
The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Grief Management Self-efficacy
Three items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a six-point scale (1 to 6) with a mean total score that ranges from 1 to 6. Higher scores indicate greater self-efficacy.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Negative Attitudes on Personal Grief
6 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree) to indicate level of agreement. A means score was computed and could range from 1 to 4. Higher scores indicate more negative experiences.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale
11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Difficulties in Emotional Regulation - Lack of Emotional Response Subscale
11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.
Measured: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Usability
The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable.
Measured: Post-Treatment (8 weeks post loss)
Acceptability
Developed as part of the current study, 7 items were designed to measure the degree, on a 5-point Likert-type scale (1 = strongly or somewhat disagree, 5 = strongly or somewhat agree) to which parents found the program helpful, acceptable, and suited to their needs. A mean score was computed across all items and could range from 1 to 5. Higher scores indicate greater acceptability.
Measured: Post-Treatment (8 weeks post loss)
Program Use - Days Using the Program
Program metrics on the backend of the program were used to track the total number of days the program was used.
Measured: Access to the program through through the study completion which was on average 2-months.
Program Use - Modules Completed
Program metrics on the backend of the program were used to track the the total number of modules completed out of the 6 modules.
Measured: Access to the program through through the study completion which was on average 2-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Feb 2021
- Primary completion12 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Camille C Cioffi, PhD, Principal investigator, Oregon Research Behavioral Intervention Strategies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318287
- Sponsor's protocol ID
- MH126788
- Acronym
- PeriGrief
- Status last verified
- Jun 2025
- First submitted
- 1 Feb 2022
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. 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
- NCT05318287
- Acronym / sponsor ID
- PeriGrief / MH126788
- Conditions
- Grief, Traumatic Stress, Usability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process.
Detailed description
The investigators will develop grief processing and healing activities for bereaved parents, via an iterative formative development process with stakeholder input. The investigators will embed the core intervention components in administrative, provider, and client interfaces which will comprise the prototype Walk with Me (WWM) intervention.
The investigators will evaluate its feasibility and initial efficacy of WWM in a within-subjects pre-post design study. The investigators will provide the mobile-based provider component for use by health care professionals (HCPs) who work in the partner hospital. HCPs will have access to training videos and bereaved parent content. After training, the HCPs will recruit 52 bereaved parents.
HCPs will obtain consent from bereaved parents who express interest in the study to share their contact information with the research team. Parents who wish to participate will provide consent for their own participation in the study. After consent, parents will complete the baseline survey via the Qualtrics online assessment form and then be provided download access to the WWM prototype. At 4 and 8 weeks, parents will be administered post-treatment surveys. This design will allow the investigators to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of the prototype WWM program.
Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences. The post-survey questionnaire will contain measures of usability, as well as any difficulties experienced or problems made worse. Demographics will be collected at the baseline assessment. Project staff will follow-up with parents as needed to encourage survey completion in a timely manner.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PeriGrief | Experimental | Behavioral: Walk with MeA brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.
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 |
|---|---|---|
| Walk with MeWalk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving. | Behavioural | PeriGrief |
Primary outcome
Traumatic Stress - Intrusion Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Impact of Event Scale-Revised (IES-R) includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Traumatic Stress - Avoidance Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Traumatic Stress - Hyperarousal Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma.
Grief Intensity - Reality Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Grief Intensity - Congruence Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Grief Intensity - Ability to Confront Others Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity.
Grief Management Self-efficacy
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Three items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a six-point scale (1 to 6) with a mean total score that ranges from 1 to 6. Higher scores indicate greater self-efficacy.
Negative Attitudes on Personal Grief
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
6 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree) to indicate level of agreement. A means score was computed and could range from 1 to 4. Higher scores indicate more negative experiences.
Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.
Difficulties in Emotional Regulation - Lack of Emotional Response Subscale
Time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions.
Usability
Time frame: Post-Treatment (8 weeks post loss)
The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable.
Acceptability
Time frame: Post-Treatment (8 weeks post loss)
Developed as part of the current study, 7 items were designed to measure the degree, on a 5-point Likert-type scale (1 = strongly or somewhat disagree, 5 = strongly or somewhat agree) to which parents found the program helpful, acceptable, and suited to their needs. A mean score was computed across all items and could range from 1 to 5. Higher scores indicate greater acceptability.
Program Use - Days Using the Program
Time frame: Access to the program through through the study completion which was on average 2-months.
Program metrics on the backend of the program were used to track the total number of days the program was used.
Program Use - Modules Completed
Time frame: Access to the program through through the study completion which was on average 2-months.
Program metrics on the backend of the program were used to track the the total number of modules completed out of the 6 modules.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Camille C Cioffi, PhD principal investigator
Oregon Research Behavioral Intervention Strategies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk with Me in people with Grief and Traumatic Stress, run by Oregon Research Behavioral Intervention Strategies, Inc. at 1 site 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic Stress - Intrusion Subscale (time frame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss). The study lists 14 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 4 Jun 2025.