Trial Outcomes & Findings for MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers (NCT NCT04600076)

NCT ID: NCT04600076

Last Updated: 2022-06-01

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

6 months

Results posted on

2022-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	BabyCenter Site and the Community Group 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 Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BabyCenter Site and the Community Group 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 Study Lost to Follow-up	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BabyCenter Site and the Community Group n=22 Participants 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.
Age, Continuous	31 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

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

Outcome measures

Outcome measures
Measure	BabyCenter Site and the Community Group n=200 Participants 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.
Percentage of Participants Approached for Enrollment Who Signed up for the Study	22 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure	BabyCenter Site and the Community Group n=22 Participants 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.
Feasibility: Retention 6 week intervention	20 Participants
Feasibility: Retention Pre-post surveys	20 Participants
Feasibility: Retention Phone interview	19 Participants

SECONDARY outcome

Timeframe: Pre intervention (day 0), Post intervention (6 weeks)

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

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.

Outcome measures

Outcome measures
Measure	BabyCenter Site and the Community Group n=17 Participants 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.
Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8) Pre-Intervention PHQ-8	9.1 score on a scale Standard Deviation 6.4
Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8) Post-Intervention PHQ-8	8.1 score on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: Pre intervention (day 0), Post intervention (6 weeks)

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

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.

Outcome measures

Outcome measures
Measure	BabyCenter Site and the Community Group n=18 Participants 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.
Change in Post-traumatic Stress Disorder (PTSD) Pre-Intervention PTSD	38.6 score on a scale Standard Deviation 14.9
Change in Post-traumatic Stress Disorder (PTSD) Post-Intervention PTSD	35.8 score on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BabyCenter Site and the Community Group n=19 Participants 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.
Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7) Pre-Intervention GAD-7	12.8 score on a scale Standard Deviation 5.7
Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7) Post-Intervention GAD-7	11.9 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BabyCenter Site and the Community Group n=19 Participants 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.
Change in Grief Based on the Perinatal Grief Scale Pre-Intervention PGS	91.9 score on a scale Standard Deviation 18.9
Change in Grief Based on the Perinatal Grief Scale Post-Intervention PGS	88.1 score on a scale Standard Deviation 19.7

Adverse Events

BabyCenter Site and the Community Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Jo Gold

University of Michigan

Phone: 734 998-2499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place