N/A
N=52
Walk With Me for Perinatal Grief
Grief · Traumatic Stress · Usability
Bottom Line
View on ClinicalTrials.gov: NCT05318287 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Traumatic Stress - Intrusion Subscale — 2.17; 1.93; 1.32 units on a scale — p=.083
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Walk with Me (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Traumatic Stress - Intrusion Subscale |
2.17; 1.93; 1.32 | .083 |
| PRIMARY Traumatic Stress - Avoidance Subscale |
1.61; 1.44; 1.23 | .010 sig |
| PRIMARY Traumatic Stress - Hyperarousal Subscale |
1.61; 1.53; 1.31 | .160 |
| PRIMARY Grief Intensity - Reality Subscale |
3.39; 3.41; 3.51 | .167 |
| PRIMARY Grief Intensity - Congruence Subscale |
2.48; 2.59; 2.66 | .012 sig |
| PRIMARY Grief Intensity - Ability to Confront Others Subscale |
2.61; 2.71; 2.55 | .347 |
| PRIMARY Grief Management Self-efficacy |
4.26; 4.63; 4.66 | .007 sig |
| PRIMARY Negative Attitudes on Personal Grief |
3.88; 3.59; 3.21 | .001 sig |
| PRIMARY Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale |
2.25; 2.35; 2.08 | .403 |
| PRIMARY Difficulties in Emotional Regulation - Lack of Emotional Response Subscale |
2.32; 2.38; 2.20 | .194 |
| PRIMARY Usability |
74.4 | — |
| PRIMARY Acceptability |
2.88 | — |
| PRIMARY Program Use - Days Using the Program |
21.40 | — |
| PRIMARY Program Use - Modules Completed |
4; 10; 9; 6; 1; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05318287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.