MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
Primary Purpose
Stillbirth, Grief, Infant Death
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BabyCenter site and the community group
Sponsored by
About this trial
This is an interventional supportive care trial for Stillbirth focused on measuring internet support site, BabyCenter.com.
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BabyCenter site and the community group
Arm Description
Outcomes
Primary Outcome Measures
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.
Feasibility: Retention
Number of participants that completed:
The 6 week intervention.
Pre-post surveys.
Phone interview
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04600076
First Posted
October 19, 2020
Last Updated
May 6, 2022
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04600076
Brief Title
MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
Official Title
MOMSonLINE2:A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stillbirth, Grief, Infant Death
Keywords
internet support site, BabyCenter.com.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BabyCenter site and the community group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
BabyCenter site and the community group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Approached for Enrollment Who Signed up for the Study
Description
Feasibility of recruitment as shown by percent of those approached for enrollment who signed up for the study.
Time Frame
6 months
Title
Feasibility: Retention
Description
Number of participants that completed:
The 6 week intervention.
Pre-post surveys.
Phone interview
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)
Description
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.
Time Frame
Pre intervention (day 0), Post intervention (6 weeks)
Title
Change in Post-traumatic Stress Disorder (PTSD)
Description
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.
Time Frame
Pre intervention (day 0), Post intervention (6 weeks)
Title
Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7)
Description
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.
Time Frame
Pre intervention (day 0), Post intervention (6 weeks)
Title
Change in Grief Based on the Perinatal Grief Scale
Description
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.
Time Frame
Pre intervention (day 0), Post intervention (6 weeks)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gave birth to a stillborn baby or had an infant death in the first 28 days of life. Age 18 or older at delivery.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Gold, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35861706
Citation
Gold KJ, Boggs ME, Plegue MA, Andalibi N. Online Support Groups for Perinatal Loss: A Pilot Feasibility Study for Women of Color. Cyberpsychol Behav Soc Netw. 2022 Aug;25(8):534-539. doi: 10.1089/cyber.2021.0304. Epub 2022 Jul 20.
Results Reference
derived
Learn more about this trial
MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
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