Grief, Infant Death, Stillbirth
Conditions
Keywords
internet support site, BabyCenter.com.
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.
Interventions
BEHAVIORALBabyCenter 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.
Sponsors
National Institutes of Health (NIH)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Feasibility: Retention | 6 weeks | Number of participants that completed: * The 6 week intervention. * Pre-post surveys. * Phone interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | BabyCenter Site and the Community Group |
|---|---|
| Age, Continuous | 31 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Feasibility: Retention
Number of participants that completed: * The 6 week intervention. * Pre-post surveys. * Phone interview
Time frame: 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BabyCenter Site and the Community Group | Feasibility: Retention | 6 week intervention | 20 Participants |
| BabyCenter Site and the Community Group | Feasibility: Retention | Pre-post surveys | 20 Participants |
| BabyCenter Site and the Community Group | Feasibility: Retention | Phone interview | 19 Participants |
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.
Time frame: 6 months
Population: This is the total number of potential participants who were actually invited to be included in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BabyCenter Site and the Community Group | Percentage of Participants Approached for Enrollment Who Signed up for the Study | 22 Participants |
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.
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BabyCenter Site and the Community Group | 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 |
| BabyCenter Site and the Community Group | 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
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.
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
Population: Only 17 participants answered all pre and post intervention survey depression questions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BabyCenter Site and the Community Group | 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 |
| BabyCenter Site and the Community Group | 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
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.
Time frame: Pre intervention (day 0), Post intervention (6 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BabyCenter Site and the Community Group | Change in Grief Based on the Perinatal Grief Scale | Post-Intervention PGS | 88.1 score on a scale | Standard Deviation 19.7 |
| BabyCenter Site and the Community Group | Change in Grief Based on the Perinatal Grief Scale | Pre-Intervention PGS | 91.9 score on a scale | Standard Deviation 18.9 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BabyCenter Site and the Community Group | Change in Post-traumatic Stress Disorder (PTSD) | Pre-Intervention PTSD | 38.6 score on a scale | Standard Deviation 14.9 |
| BabyCenter Site and the Community Group | Change in Post-traumatic Stress Disorder (PTSD) | Post-Intervention PTSD | 35.8 score on a scale | Standard Deviation 13.6 |