N/A
N=22
MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
Stillbirth · Grief · Infant Death
Bottom Line
View on ClinicalTrials.gov: NCT04600076 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Percentage of Participants Approached for Enrollment Who Signed up for the Study — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BabyCenter site and the community group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Approached for Enrollment Who Signed up for the Study |
22 | — |
| PRIMARY Feasibility: Retention |
20; 20; 19 | — |
| SECONDARY Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8) |
9.1; 8.1 | — |
| SECONDARY Change in Post-traumatic Stress Disorder (PTSD) |
38.6; 35.8 | — |
| SECONDARY Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7) |
12.8; 11.9 | — |
| SECONDARY Change in Grief Based on the Perinatal Grief Scale |
91.9; 88.1 | — |
Summary
This is a 6-week pilot study to see how research participants feel about an internet support site after a stillbirth or infant death. Losing a baby through stillbirth or early infant death is typically devastating for families. However, investigators do not know if internet on-line support for parents helps manage grief more easily.
In addition to using the BabyCenter.com website, participants will be asked to complete online surveys at the beginning and the end of the study, as well partake in an interview.
Data from this pilot study will help develop a much larger randomized control study of on-line support outcomes after perinatal loss.
Eligibility Criteria
Inclusion Criteria
- Michigan residence and infant delivery
- Non-Caucasian race and/or Hispanic ethnicity
- Read/speak English
- Gave birth to a stillborn baby or had an infant death in the first 28 days of life
- Did not give the baby up for adoption pre-loss
- Internet access
Exclusion Criteria
- Don't Read/speak English
Data sourced from ClinicalTrials.gov (NCT04600076). 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.