Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05318287
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2022-02-01
Brief Title:
Walk With Me for Perinatal Grief
Sponsor:
Oregon Research Behavioral Intervention Strategies Inc
Organization:
Oregon Research Behavioral Intervention Strategies Inc
Study Overview
Official Title:
Walk With Me WWM for Perinatal Grief
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeriGrief
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None