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

NCT ID: NCT04600076

Last Updated: 2022-06-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Stillbirth Grief Infant Death

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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BabyCenter site and the community group

Group Type EXPERIMENTAL

BabyCenter site and the community group

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Katherine Gold

Associate Professor of Family Medicine and Associate Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Gold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37217328 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35861706 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UL1TR002240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00159800

Identifier Type: -

Identifier Source: org_study_id

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