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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04600076
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stillbirth; Grief; Infant Death	Behavioral: BabyCenter site and the community group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: MOMSonLINE2:A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
• Actual Study Start Date: Nov 20, 2020
• Actual Primary Completion Date: Aug 15, 2021
• Actual Study Completion Date: Aug 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Approached for Enrollment Who Signed up for the Study [6 months]

   Feasibility of recruitment as shown by percent of those approached for enrollment who signed up for the study.

2. Feasibility: Retention [6 weeks]

   Number of participants that completed: The 6 week intervention. Pre-post surveys. Phone interview

Secondary Outcome Measures

1. Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8) [Pre intervention (day 0), Post intervention (6 weeks)]

   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.

2. Change in Post-traumatic Stress Disorder (PTSD) [Pre intervention (day 0), Post intervention (6 weeks)]

   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.

3. Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7) [Pre intervention (day 0), Post intervention (6 weeks)]

   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.

4. Change in Grief Based on the Perinatal Grief Scale [Pre intervention (day 0), Post intervention (6 weeks)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Katherine Gold, MD, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 18, 2020
• Informed Consent Form - Oct 24, 2020

More Information

Publications

None provided.

• Responsible Party: Katherine Gold, Associate Professor of Family Medicine and Associate Professor of Obstetrics and Gynecology, University of Michigan
• ClinicalTrials.gov Identifier: NCT04600076
• Other Study ID Numbers: HUM00159800; UL1TR002240
• First Posted: Oct 23, 2020
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Katherine Gold, Associate Professor of Family Medicine and Associate Professor of Obstetrics and Gynecology, University of Michigan: internet support site; BabyCenter.com.
• Additional relevant MeSH terms: Stillbirth; Infant Death

Study Results

Participant Flow

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Period Title: Overall Study
STARTED	22
COMPLETED	19
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Overall Participants	22
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	31
Sex: Female, Male (Count of Participants)
Female	22 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 13.6%
Not Hispanic or Latino	19 86.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 4.5%
Asian	1 4.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	13 59.1%
White	3 13.6%
More than one race	4 18.2%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	22 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Approached for Enrollment Who Signed up for the Study
Description	Feasibility of recruitment as shown by percent of those approached for enrollment who signed up for the study.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This is the total number of potential participants who were actually invited to be included in the study.

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Measure Participants	200
Count of Participants [Participants]	22 100%

2. Primary Outcome

Title	Feasibility: Retention
Description	Number of participants that completed: The 6 week intervention. Pre-post surveys. Phone interview
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Measure Participants	22
6 week intervention	20 90.9%
Pre-post surveys	20 90.9%
Phone interview	19 86.4%

3. Secondary Outcome

Title	Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)
Description	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.
Time Frame	Pre intervention (day 0), Post intervention (6 weeks)

Outcome Measure Data

Analysis Population Description

Only 17 participants answered all pre and post intervention survey depression questions.

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Measure Participants	17
Pre-Intervention PHQ-8	9.1 (6.4)
Post-Intervention PHQ-8	8.1 (5.2)

4. Secondary Outcome

Title	Change in Post-traumatic Stress Disorder (PTSD)
Description	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.
Time Frame	Pre intervention (day 0), Post intervention (6 weeks)

Outcome Measure Data

Analysis Population Description

Of all the participants who completed, analysis covers only those who answered all questions on pre and post surveys.

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Measure Participants	18
Pre-Intervention PTSD	38.6 (14.9)
Post-Intervention PTSD	35.8 (13.6)

5. Secondary Outcome

Title	Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7)
Description	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.
Time Frame	Pre intervention (day 0), Post intervention (6 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Measure Participants	19
Pre-Intervention GAD-7	12.8 (5.7)
Post-Intervention GAD-7	11.9 (5.6)

6. Secondary Outcome

Title	Change in Grief Based on the Perinatal Grief Scale
Description	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.
Time Frame	Pre intervention (day 0), Post intervention (6 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
Measure Participants	19
Pre-Intervention PGS	91.9 (18.9)
Post-Intervention PGS	88.1 (19.7)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	BabyCenter Site and the Community Group
Arm/Group Description	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.
All Cause Mortality
	BabyCenter Site and the Community Group
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Serious Adverse Events
	BabyCenter Site and the Community Group
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Other (Not Including Serious) Adverse Events
	BabyCenter Site and the Community Group
	Affected / at Risk (%)	# Events
Total	0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.