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OpenTrials
Completed

NCT Number: NCT05318287

Walk With Me 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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusions Criteria

Focus Groups and Usability Testing (Bereaved Parents)

  • Experienced a perinatal loss
  • Have had at least 6 months pass since experiencing the most recent loss
  • Age 15 and older

Efficacy Study (Bereaved Parents)

  • Bereaved parent who has experienced a perinatal loss within the last two weeks * Age 15 and older
  • Have access to technology to view WWM content

Exclusion criteria

  • Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.

Treatment and study plan

Walk with Me

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Industry

Registry information

Official study title

Walk With Me (WWM) for Perinatal Grief

Acronym: PeriGrief

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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