Walk With Me for Perinatal Grief (PeriGrief)

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.

Study Overview

• Status: Completed
• Conditions: Grief; Usability; Traumatic Stress
• Intervention / Treatment: Behavioral: Walk with Me

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Research Behavioral Intervention Strategies, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PeriGrief; 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.	Behavioral: Walk with Me; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-Treatment (8 weeks post loss)
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline (immediately following loss), 4 weeks and 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.	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.	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.	Access to the program through through the study completion which was on average 2-months.

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
• Investigators: Principal Investigator: Camille C Cioffi, PhD, Oregon Research Behavioral Intervention Strategies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MH126788

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No