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MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
NA trial testing BabyCenter site and the community group in Stillbirth in 22 participants. Completed in 15 August 2021.
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 22 |
| Start date | 20 November 2020 |
| Primary completion | 15 August 2021 |
| Estimated completion | 15 August 2021 |
| Sites | 1 location across United States |
University of Michigan
18 and older, female only, with Stillbirth or Grief. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of recruitment as shown by percent of those approached for enrollment who signed up for the study.
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 22 |
Number of participants that completed: * The 6 week intervention. * Pre-post surveys. * Phone interview
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 20 |
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 20 |
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 19 |
The Personal Health Questionnaire Depression (PHQ-8) is a widely used and validated screen for depression. The PHQ-8 is scored by adding scores from each question (0-3) to a final score (0 to 24). Higher scores indicate worse outcome and a score of 10 or higher indicates a positive screen. A positive screen is probable for clinical depression.
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 9.1 | ± 6.4 |
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 8.1 | ± 5.2 |
PTSD will be measured using the 20-question Post-traumatic stress disorder (PTSD) checklist for the Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 (PTSD Checklist for DSM-5, Civilian Version). Scores range from 0-80. A score of 33 or above will be used as our cutoff. A score above this indicated a probable diagnosis of PTSD.
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 38.6 | ± 14.9 |
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 35.8 | ± 13.6 |
The Generalized Anxiety Disorder screen (GAD-7) is a seven-item self-report instrument for screening, diagnosis and severity assessment of anxiety disorder. The GAD-7 total score for the seven items ranges from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety.
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 12.8 | ± 5.7 |
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 11.9 | ± 5.6 |
The Perinatal Grief Scale measures grief, coping, and despair following the death of a child. It includes 33 questions on a 5-point Likert scale that ranges from 1=strongly agree to 5=strongly disagree. A higher score would indicate more grief and a lower score less grief. A score cutoff of \>40 to indicates more severe grief. Two questions were inadvertently dropped from the PGS in our surveys; this allows pre-post analysis but limits comparison to other studies. With this omission, our PGS scores could range from 31 -155.
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 91.9 | ± 18.9 |
| Group | Value | 95% CI |
|---|---|---|
| BabyCenter Site and the Community Group | 88.1 | ± 19.7 |
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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