MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers

Study Overview
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Brief Summary
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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.

Official Title
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MOMSonLINE2:A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers

Conditions
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Stillbirth, Grief, Infant Death

Intervention / Treatment
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* Behavioral: BabyCenter site and the community group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BabyCenter site and the community group<br> | Behavioral: BabyCenter site and the community group<br>* Participants will be asked to sign on to the BabyCenter community group for people with pregnancy or infant loss at least 3 times weekly for 6 weeks. Participants may choose to post or comment on the site but are not required to do so.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Approached for Enrollment Who Signed up for the Study | Feasibility of recruitment as shown by percent of those approached for enrollment who signed up for the study. | 6 months | 
| Feasibility: Retention | Number of participants that completed: The 6 week intervention. Pre-post surveys. Phone interview | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8) | 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. | Pre intervention (day 0), Post intervention (6 weeks) | 
| Change in Post-traumatic Stress Disorder (PTSD) | 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. | Pre intervention (day 0), Post intervention (6 weeks) | 
| Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7) | 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. | Pre intervention (day 0), Post intervention (6 weeks) | 
| Change in Grief Based on the Perinatal Grief Scale | 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. | Pre intervention (day 0), Post intervention (6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet support site, BabyCenter.com.