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

NCT04600076 | Completed Results

• 2 other identifiers: HUM00159800UL1TR002240
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Stillbirth; Grief; Infant Death

Keywords

internet support site; BabyCenter.com.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (1)

BabyCenter site and the community group

EXPERIMENTAL

Behavioral: BabyCenter site and the community group

Interventions

BabyCenter site and the community group BEHAVIORAL

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.

BabyCenter site and the community group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gave birth to a stillborn baby or had an infant death in the first 28 days of life. Age 18 or older at delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Don't Read/speak English

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Gold KJ, Dobson ML, Sen A. "Three Good Things" Digital Intervention Among Health Care Workers: A Randomized Controlled Trial. Ann Fam Med. 2023 May-Jun;21(3):220-226. doi: 10.1370/afm.2963.

  PMID: 37217328 DERIVED

• 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.

  PMID: 35861706 DERIVED

MeSH Terms

Conditions

Stillbirth; Infant Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Katherine Jo Gold
• Organization: University of Michigan

ktgold@med.umich.edu

734 998-2499

Study Officials

• Katherine Gold, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Family Medicine and Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: November 20, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: June 1, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)