Walk With Me for Perinatal Grief

Grief Clinical Trial

— PeriGrief  

Official title:

Walk With Me (WWM) for Perinatal Grief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318287
• Other study ID #: MH126788
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: Oregon Research Behavioral Intervention Strategies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 support the grieving process.

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 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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 30, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Grief
• Traumatic Stress
• Usability

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Research Behavioral Intervention Strategies, Inc.	Springfield	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traumatic stress will be analyzed as change over time	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." Higher scores indicate greater distress/trauma. Participants will be instructed to relate the IES-R items specifically to the loss of their child. The investigators will examine scores as a continuous variable and presence/absence of diagnosis using a cutoff score of 35 or more.	Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Primary	Grief intensity will be analyzed as change over time	The Perinatal Grief Intensity Scale is 14 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale (1 to 4) and is averaged across three scales with a total possible score of 4. Higher overall scores indicating higher intensity of grief.	Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Primary	Grief	The Perinatal Bereavement Scale is a 15-item scale designed as a measure of grief and yearning for the lost pregnancy and the lost baby. Respondents indicate how often the statement has been true in the past week, using a 4-point Likert-type scale ranging from rarely or none of the time, less than 1 day (scored 1) to most or all of the time, 5 to 7 days (scored 4). Responses are summed to yield a total score (possible range, 15-60)	Baseline (immediately following loss)
Primary	Grief management self-efficacy will be analyzed as a change over time	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 four-point scale (1 to 4) with a total available score of 12. Higher scores indicate greater self-efficacy.	4 weeks and 8 weeks post loss
Primary	Care experiences will be analyzed as a change over time	11 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale (1 to 4) to indicate level of agreement with a total available score of 44. Higher scores indicating better experiences.	Baseline (immediately following loss), 4 weeks and 8 weeks post loss
Primary	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)
Primary	Acceptability	Developed as part of the current study. Items developed to measure the degree, on a 7-point Likert-type scale, to which parents found the program helpful, acceptable, and suited to their needs. Higher scores will indicate greater acceptability.	Post-Treatment (8 weeks post loss)