Clinical trial NCT05318287: Walk With Me for Perinatal Grief
Official title: Walk With Me (WWM) for Perinatal Grief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Traumatic Stress
Usability
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Traumatic Stress - Intrusion Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Traumatic Stress - Avoidance Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Traumatic Stress - Hyperarousal Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Grief Intensity - Reality Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Grief Intensity - Congruence Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Grief Intensity - Ability to Confront Others Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Grief Management Self-efficacy
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Negative Attitudes on Personal Grief
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Difficulties in Emotional Regulation - Lack of Emotional Response Subscale
timeFrame: Baseline (immediately following loss), 4 weeks and 8 weeks post loss
measure: Usability
timeFrame: Post-Treatment (8 weeks post loss)
measure: Acceptability
timeFrame: Post-Treatment (8 weeks post loss)
measure: Program Use - Days Using the Program
timeFrame: Access to the program through through the study completion which was on average 2-months.
measure: Program Use - Modules Completed
timeFrame: Access to the program through through the study completion which was on average 2-months.
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
name: Camille C Cioffi, PhD
role: PRINCIPAL_INVESTIGATOR
References: