Walk With Me for Perinatal Grief (PeriGrief)

Oregon Research Behavioral Intervention Strategies

Status: Completed

Conditions: Grief; Traumatic Stress; Usability

Treatments: Behavioral: Walk with Me

Study type: Interventional

Funder types: Industry

Identifiers

NCT05318287

MH126788

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

PeriGrief

Experimental group

Description:

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.

Treatment:

Behavioral: Walk with Me