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

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

Sponsors

Lead Sponsor: University of Michigan

Collaborator: National Institutes of Health (NIH)

Source University of Michigan
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 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.

Overall Status Not yet recruiting
Start Date November 2020
Completion Date October 2021
Primary Completion Date October 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility: Recruitment 6 months
Feasibility: Retention 6 weeks
Secondary Outcome
Measure Time Frame
Change in Depression as measured by The Personal Health Questionnaire Depression (PHQ-8) Pre intervention (day 0), Post intervention (6 weeks)
Change in Post-traumatic stress Disorder (PTSD) Pre intervention (day 0), Post intervention (6 weeks)
Change in anxiety based on the Generalized Anxiety Disorder screen (GAD-7) Pre intervention (day 0), Post intervention (6 weeks)
Change in grief based on the Perinatal Grief Scale Pre intervention (day 0), Post intervention (6 weeks)
Enrollment 75
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: BabyCenter site and the community group

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.

Arm Group Label: BabyCenter site and the community group

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

Gender: Female

Gender Based: Yes

Gender 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: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Katherine Gold, MD Principal Investigator University of Michigan
Overall Contact

Last Name: Martha Boggs

Phone: 734-998-4122

Email: [email protected]

Location
Facility: Contact: University of Michigan Martha Boggs 734-998-4122 [email protected]
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Michigan

Investigator Full Name: Katherine Gold

Investigator Title: Associate Professor of Family Medicine and Associate Professor of Obstetrics and Gynecology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: BabyCenter site and the community group

Type: Experimental

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov