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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children.
A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes.
Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination |
|
| Intervention | Experimental | Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parental stress management | Behavioral | The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches." |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom-free Days in the Last 14 Days | Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications | Repeated Measures at 6 months (3 month data collected to allow for repeated measures) |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Morbidity - Nighttime Asthma Symptoms | Nights of asthma symptoms in prior 14d | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Asthma Severity and Control |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographics | Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history | Baseline |
| Number of Participants With Positive Smoke Exposure | Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure. |
We plan to enroll parent-child dyads that meet the following criteria:
Inclusion criteria (Parent):
Exclusion criteria (Parent):
Inclusion criteria (Child):
Exclusion criteria (Child):
- chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.
In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Teach, MD, MPH | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31545115 | Derived | Teach SJ, Shelef DQ, Foushee N, Horn IB, Yadav K, Wang Y, Rand CS, Streisand R. Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes. J Asthma. 2021 Jan;58(1):121-132. doi: 10.1080/02770903.2019.1665063. Epub 2019 Sep 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination |
| FG001 | Intervention | Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches." |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Six Month Follow Up |
| |||||||||||||
| Twelve Month FollowUp |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Symptom-free Days in the Last 14 Days | Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications | Randomized participants with follow up available at each time period. | Posted | Mean | Standard Deviation | days in prior 14d | Repeated Measures at 6 months (3 month data collected to allow for repeated measures) |
|
For duration of trial (12 months following enrollment of each participant)
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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 | Usual Care | IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination Usual Care: IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Teach, MD, MPH | Children's Research Institute | 202 476 5134 | steach@childrensnational.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2016 | Nov 7, 2017 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 26, 2017 | Nov 8, 2017 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Usual Care | Other | IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination |
|
| Repeated Measures at 3, 6, and 12 months |
| Asthma Medication Adherence | Reported use of inhaled corticosteroids and LTRA in past two days | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Health Care Utilization - Emergency Department Visits for Asthma | Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere | 12 months after enrollment |
| Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids over 12m follow up period | Assessed at 6m and 12m following enrollment |
| Parental Stress | Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress. | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Parental Depression | Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms. | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Child Anxiety | PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression. | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Child Depression | PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression. | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Caregiver Quality of Life | Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed. | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Number of Participants With AEs and SAEs | Safety data: Number of Participants with AEs and SAEs | 12m follow up period |
| Economic Outcomes | Analysis of costs of care in both groups | 12m follow-up period |
| Caregiver Smoking Behavior | parent report of cigarettes smoked per day | Repeated Measures at 6 and 12 months |
| Coping Strategies | Brief COPE | Repeated measures at 12m FU (6m data used for repeated measures) |
| Mindfulness | Interpersonal Mindfulness in Parenting | Repeated Measures at 6 and 12 months |
| Parental Resilience | Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism. | Repeated Measures at 6 and 12 months |
| Exacerbations - Hospital Admissions | Number of participants with hospital admissions due to exacerbations | Assessed at 6m and 12m after enrollment |
| Symptom-free Days in the Last 14 Days | Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications | Repeated Measures at 12 months (with data also assessed at 3m and 6m) |
| Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d | Repeated measures at 6 and 12 months (3m data collected for repeated measures) |
| Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
| Parental Health Literacy | Single Item Literacy Screener (SILS) | Baseline |
| Use of Existing Ancillary Services | Assessed at 6m and 12m following enrollment |
| Parental Resilience | Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism. | Baseline |
| Intervention Component Uptake | Completion of intervention sessions | 6 month intervention period |
| Intervention Satisfaction | Brief survey of satisfaction with intervention components. | 6 month intervention period |
| Intervention Fidelity | Checklist of staff's fidelity to individual components of intervention protocol | 6 month intervention period |
| NOT COMPLETED |
|
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches." |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches." |
|
|
|
| Secondary | Asthma Morbidity - Nighttime Asthma Symptoms | Nights of asthma symptoms in prior 14d | Participants with data available at each follow up time point | Posted | Mean | Standard Deviation | days in prior 14d | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Asthma Severity and Control | Data not collected | Posted | Repeated Measures at 3, 6, and 12 months |
|
|
| Secondary | Asthma Medication Adherence | Reported use of inhaled corticosteroids and LTRA in past two days | Participants with Follow Up Data Available at Each Time Point | Posted | Count of Participants | Participants | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Health Care Utilization - Emergency Department Visits for Asthma | Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere | Participants with follow up available at each time point | Posted | Mean | Standard Error | Visits | 12 months after enrollment |
|
|
|
|
| Secondary | Asthma Exacerbations - Courses of Systemic Steroids | Courses of systemic steroids over 12m follow up period | Participants with data available at each time point | Posted | Mean | Standard Error | Courses of systemic steroids | Assessed at 6m and 12m following enrollment |
|
|
|
|
| Secondary | Parental Stress | Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress. | Number of participants with follow up available at each time point. | Posted | Mean | Standard Deviation | units on a scale | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Parental Depression | Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms. | Participants available at each follow up time point. | Posted | Mean | Standard Deviation | units on a scale | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Child Anxiety | PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression. | Participants available at each time point | Posted | Mean | Standard Deviation | units on a scale | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Child Depression | PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression. | Participants available at each time point | Posted | Mean | Standard Deviation | units on a scale | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Caregiver Quality of Life | Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed. | Participants with follow up available at each time point. Note use of modified scale. | Posted | Mean | Standard Deviation | units on a scale | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Secondary | Number of Participants With AEs and SAEs | Safety data: Number of Participants with AEs and SAEs | Participants available at each time point | Posted | Count of Participants | Participants | 12m follow up period |
|
|
|
|
| Secondary | Economic Outcomes | Analysis of costs of care in both groups | Data were not collected | Posted | 12m follow-up period |
|
|
| Secondary | Caregiver Smoking Behavior | parent report of cigarettes smoked per day | We are unable to analyze or report the data because it was not systematically collected. | Posted | Repeated Measures at 6 and 12 months |
|
|
| Secondary | Coping Strategies | Brief COPE | While we have collected this data, its analysis will be complex and require significant resources. We lack those resources at this time. We may at some point in the future return to this analysis. | Posted | Repeated measures at 12m FU (6m data used for repeated measures) |
|
|
|
| Secondary | Mindfulness | Interpersonal Mindfulness in Parenting | We are unable to analyze or report the data because it was not systematically collected. | Posted | Repeated Measures at 6 and 12 months |
|
|
| Secondary | Parental Resilience | Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism. | Participants with follow up available at each time point | Posted | Mean | Standard Deviation | units on a scale | Repeated Measures at 6 and 12 months |
|
|
|
|
| Secondary | Exacerbations - Hospital Admissions | Number of participants with hospital admissions due to exacerbations | Participants with data available at each time point | Posted | Count of Participants | Participants | Assessed at 6m and 12m after enrollment |
|
|
|
| Secondary | Symptom-free Days in the Last 14 Days | Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications | Participants with data available at 12m follow up | Posted | Mean | Standard Deviation | days | Repeated Measures at 12 months (with data also assessed at 3m and 6m) |
|
|
|
|
| Secondary | Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use | Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d | Participants with data available at each follow up time point | Posted | Mean | Standard Deviation | days in prior 14d | Repeated measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Other Pre-specified | Sociodemographics | Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history | Posted | Count of Participants | Participants | Baseline |
|
|
|
|
| Other Pre-specified | Number of Participants With Positive Smoke Exposure | Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure. | Number of participants with follow up data available at each time point. | Posted | Count of Participants | Participants | Repeated Measures at 6 and 12 months (3m data collected for repeated measures) |
|
|
|
|
| Other Pre-specified | Parental Health Literacy | Single Item Literacy Screener (SILS) | Posted | Count of Participants | Participants | Baseline |
|
|
|
|
| Other Pre-specified | Use of Existing Ancillary Services | Participants with data available at each follow up point | Posted | Count of Participants | Participants | Assessed at 6m and 12m following enrollment |
|
|
|
|
| Other Pre-specified | Parental Resilience | Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
|
| Other Pre-specified | Intervention Component Uptake | Completion of intervention sessions | Intervention group only | Posted | Count of Participants | Participants | 6 month intervention period |
|
|
|
| Other Pre-specified | Intervention Satisfaction | Brief survey of satisfaction with intervention components. | Participants with data available at 6 month follow up | Posted | Count of Participants | Participants | 6 month intervention period |
|
|
|
| Other Pre-specified | Intervention Fidelity | Checklist of staff's fidelity to individual components of intervention protocol | Not Posted | 6 month intervention period | Participants |
| 0 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | Intervention | Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination. Parental stress management: The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches." | 0 | 107 | 0 | 107 | 0 | 107 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| >=65 years |
|
| Nighttime asthma symptoms at 12 Month FU |
|
|
| Generalized Linear Model Analysis |
| 0.25 |
By repeated measures, p-value adjusted for age and gender |
| Superiority |
| ICS use at 12 Month Follow up |
|
|
| LTRA use at 6 Month Follow Up |
|
|
| LTRA use at 12 Month Follow Up |
|
|
| Generalized Linear Model Analysis |
| 0.34 |
By repeated measures, p-value adjusted for age and gender |
| Superiority |
| LTRA Use at 6 Months | Generalized Linear Model Analysis | 0.35 | By repeated measures, p-value adjusted for age and gender | Superiority |
| LTRA use at 12 Month Follow Up | Generalized Linear Model Analysis | 0.62 | By repeated measures, p-value adjusted for age and gender | Superiority |
| ED Visits between 6m and 12m Follow up |
|
|
| Generalized Linear Model Analysis |
| 0.44 |
Adjusted for child age, gender, and baseline value |
| Superiority |
| Courses of systemic steroids btwn 6m and 12m FU |
|
|
| Generalized Linear Model Analysis |
| 0.48 |
Adjusted for child age, gender, and baseline value |
| Superiority |
| PSS Score at 12 Month Follow up |
|
|
| Generalized Linear Model Analysis |
| 0.06 |
By repeated measures, p-value adjusted for age and gender |
| Superiority |
| CES-D 10 score at 12 Month Follow up |
|
|
| Generalized Linear Model Analysis |
| 0.44 |
By repeated measures, p-value adjusted for age and gender |
| Superiority |
| Score at 12 Month Follow Up |
|
|
| Generalized Linear Model Analysis |
| 0.80 |
Repeated measures, p-value adjusted for age and gender |
| Superiority |
| Score at 12 Month Follow Up |
|
|
| Generalized Linear Model Analysis |
| 0.77 |
Repeated measures, p-value adjusted for age and gender |
| Superiority |
| Score at 12 Month Follow Up |
|
|
| Generalized Linear Model Analysis |
| 0.57 |
Repeated measures, p-value adjusted for age and gender |
| Superiority |
| 12 Month Follow up |
|
|
| Score on LOT-R at 12 month Follow Up |
|
|
| Generalized Linear Model Analysis |
| 0.62 |
Repeated measures, p-value adjusted for age and gender |
| Superiority |
| Pts hospitalized btwn 6m and 12m FU |
|
|
| Daytime asthma symptoms at 12m FU |
|
|
| Days of activity limitation at 6m |
|
|
| Days of activity limitation at 12m |
|
|
| Days of quick relief medicine use at 6m |
|
|
| Days of quick relief medicine use at 12m |
|
|
By repeated measures, p-value adjusted for age and gender |
| 0.11 |
| Superiority |
Daytime Asthma Symptoms at 12 month follow up |
| Generalized Linear Model Analysis | By repeated measures, p-value adjusted for age and gender | 0.82 | Superiority | Days of Activity Limitations at 6 month follow up |
| Generalized Linear Model Analysis | By repeated measures, p-value adjusted for age and gender | 0.84 | Superiority | Days of Activity Limitations at 12 month follow up |
| Generalized Linear Model Analysis | By repeated measures, p-value adjusted for age and gender | 0.70 | Superiority | Days of Quick Relief Medicine Use at 6 month follow up |
| Generalized Linear Model Analysis | By repeated measures, p-value adjusted for age and gender | 0.58 | Superiority | Days of Quick Relief Medicine Use at 12 month follow up |
| Parent Ethnicity: Non-Hispanic |
|
| Child Ethnicity: Non-Hispanic |
|
| Public Insurance |
|
| Parent Education: Grade 1-11 |
|
| Parent Education: GED or 12th grade |
|
| Parent Education: Some college/associates degree |
|
| Parent Education: College Graduate |
|
| 12 Month Follow up |
|
|
| Generalized Linear Model Analysis |
| 0.98 |
Repeated measures, p-value adjusted for age and gender |
| Superiority |
| Parent use of mental health resources at 12 Months |
|
|
| Generalized Linear Model Analysis |
| 0.85 |
p-value adjusted for age and gender |
| Superiority |
| Completed 3 Intervention Sessions |
|
| Completed 4 Intervention Sessions |
|