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NCT Number: NCT04600076

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants Approached for Enrollment Who Signed up for the Study

    Time frame: 6 months

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

  2. Feasibility: Retention

    Time frame: 6 weeks

    Number of participants that completed:

    • The 6 week intervention.
    • Pre-post surveys.
    • Phone interview

Secondary outcomes

  1. Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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