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

Stillbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600076
• Other study ID #: HUM00159800
• Secondary ID: UL1TR002240
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: May 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Grief
• Infant Death
• Stillbirth

Intervention

Behavioral:
• BabyCenter site and the community group
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility: Retention	Number of participants that completed: The 6 week intervention.; Pre-post surveys.; Phone interview	6 weeks
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)