Walk With Me for Perinatal Grief

NCT05318287 | Completed Results

• 1 other identifier: MH126788
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 support the grieving process.

Conditions

Grief; Traumatic Stress; Usability

Outcome Measures

Primary Outcomes (14)

• 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

• 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)

• 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.

Study Arms (1)

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.

Behavioral: Walk with Me

Interventions

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.

PeriGrief

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Results Point of Contact

• Title: David Smith
• Organization: Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations

david.smith@influetnsin.com

541-484-2123

Study Officials

• Camille C Cioffi, PhD

  Oregon Research Behavioral Intervention Strategies, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: April 8, 2022
• Study Start: February 1, 2021
• Primary Completion: September 12, 2023
• Study Completion: September 30, 2023
• Last Updated: June 4, 2025
• Results First Posted: December 13, 2024

Record last verified: 2025-06

Locations

US (1)