StillbirthNCT04600076
MOMSonLINE2 ; A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
A study testing BabyCenter site and the community group in people with Stillbirth and Grief, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stillbirth, Grief, Infant Death
- What is being tested?
- BabyCenter site and the community group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Don't Read/speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stillbirth, Grief, Infant Death
- Being tested
- BabyCenter site and the community group
- Keywords
- internet support site, BabyCenter.com.
- Medical subject headings
- Stillbirth, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyCenter site and the community groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BabyCenter site and the community group | Experimental | Not described Receives: Behavioral: BabyCenter site and the community group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Feasibility: Retention
Number of participants that completed:
- The 6 week intervention.
- Pre-post surveys.
- Phone interview
Measured: 6 weeks
Secondary outcomes (4)
Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)
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.
Measured: Pre intervention (day 0), Post intervention (6 weeks)
Change in Post-traumatic Stress Disorder (PTSD)
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.
Measured: Pre intervention (day 0), Post intervention (6 weeks)
Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7)
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.
Measured: Pre intervention (day 0), Post intervention (6 weeks)
Change in Grief Based on the Perinatal Grief Scale
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.
Measured: Pre intervention (day 0), Post intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start20 Nov 2020
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Katherine Gold, University of Michigan
- Investigators
- Katherine Gold, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600076
- Sponsor's protocol ID
- HUM00159800
- Other IDs
- UL1TR002240
- Status last verified
- May 2022
- First submitted
- 19 Oct 2020
- Last updated
- 1 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37217328Gold 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.
PubMed 35861706
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOMSonLINE2:A Pilot Study Testing Recruitment and Retention of Women of Color to an Online Support Group for Bereaved Mothers
- ClinicalTrials.gov ID
- NCT04600076
- Acronym / sponsor ID
- HUM00159800
- Conditions
- Stillbirth, Grief, Infant Death
- Keywords
- internet support site, BabyCenter.com.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 1 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BabyCenter site and the community group | Experimental | Behavioral: BabyCenter site and the community group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Don't Read/speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BabyCenter site and the community groupParticipants 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. | Behavioural | BabyCenter site and the community group |
Primary outcome
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.
Feasibility: Retention
Time frame: 6 weeks
Number of participants that completed: * The 6 week intervention. * Pre-post surveys. * Phone interview
4 secondary outcomes
Change in Depression as Measured by The Personal Health Questionnaire Depression (PHQ-8)
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
Change in Post-traumatic Stress Disorder (PTSD)
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
Change in Anxiety Based on the Generalized Anxiety Disorder Screen (GAD-7)
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
Change in Grief Based on the Perinatal Grief Scale
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37217328Gold 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.
- Derived from this study: PubMed 35861706Gold 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Gold, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BabyCenter site and the community group in people with Stillbirth and Grief, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Approached for Enrollment Who Signed up for the Study (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600076, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.