Walk With Me for Perinatal Grief

Not Applicable

Completed

Conditions: Traumatic Stress
Usability
Grief

Interventions: Behavioral: Walk with Me

Registration Number: NCT05318287

Lead Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PeriGrief	Walk with Me	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.

Primary Outcome Measures

Name	Time	Method
Traumatic Stress - Intrusion Subscale	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	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	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	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	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	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	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	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	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	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	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	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	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	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.