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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002240 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BabyCenter site and the community group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Feasibility: Retention | Number of participants that completed:
| 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Gave birth to a stillborn baby or had an infant death in the first 28 days of life. Age 18 or older at delivery.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Gold, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37217328 | Derived | 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. | |
| 35861706 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This is the total number of potential participants who were actually invited to be included in the study. | Posted | Count of Participants | Participants | 6 months |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Jo Gold | University of Michigan | 734 998-2499 | ktgold@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2020 | Oct 21, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2020 | Sep 13, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D066088 | Infant Death |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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. | 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. | 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. | Pre intervention (day 0), Post intervention (6 weeks) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| Primary | Feasibility: Retention | Number of participants that completed:
| Posted | Count of Participants | Participants | 6 weeks |
|
|
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| Secondary | 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. | Only 17 participants answered all pre and post intervention survey depression questions. | Posted | Mean | Standard Deviation | score on a scale | Pre intervention (day 0), Post intervention (6 weeks) |
|
|
|
| Secondary | 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. | Of all the participants who completed, analysis covers only those who answered all questions on pre and post surveys. | Posted | Mean | Standard Deviation | score on a scale | Pre intervention (day 0), Post intervention (6 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre intervention (day 0), Post intervention (6 weeks) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre intervention (day 0), Post intervention (6 weeks) |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
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| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
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