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

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.

Study Overview

• Status: Completed
• Conditions: Infant Death; Grief; Stillbirth
• Intervention / Treatment: Behavioral: BabyCenter site and the community group

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BabyCenter site and the community group	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Katherine Gold, MD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: internet support site; BabyCenter.com.
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Infant Death; Stillbirth
• Other Study ID Numbers: HUM00159800; UL1TR002240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No