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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL123609-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University at Buffalo | OTHER |
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The investigators propose a one-year, repeated measures, within-subject design to examine the impact of improved caregiver depression on child asthma outcomes. A cross-lagged panel modeling (CLPM) for longitudinal data will be fit using a maximum likelihood structural equation model (SEM) in order to explore longitudinal mediation between asthma outcomes (asthma control, spirometry, quality of life (QOL)) and depressive symptoms. CLPM will test whether caregiver improvement preceded child asthma improvement, and SEM will test whether improved adherence and/or decreased child anxiety/depression mediated the effect. The investigators considered a randomized control trial, but it would not be ethically acceptable to withhold medication from caregivers diagnosed with Major Depressive Disorder (MDD) for the proposed one-year duration of the study. It is unlikely that potential participants in the study would find this acceptable. Furthermore a controlled design is not necessary since the investigators are not testing the efficacy of antidepressants for depression, but rather the impact of improvement on caregiver depression on the child.
Caregiver will be consented for his/her and the child's participation. The child will assent to participate before study procedures begin. The proposed study will last 52 weeks and consist of study visits every 4 weeks (14 visits total).
Screening (roughly 5 mins):
2 item Self-Report Screening Tool for Depression (2-SRSD) This tool will be used to help screen caregivers for the study.
This screening will only be performed in the clinic. Additional screening will be performed at the Baseline visit including:
The baseline visit is described below:
Baseline (approx 3 hrs):
The following assessments will be given to the Caregiver only:
The following assessments will be given to the child:
The following assessments will be given to both the caregiver AND the child:
1. Childhood Asthma Management Program Continuation Study Medication Adherence Interview (CAMPCS)
Weeks 4-48 (visits every 4 weeks, each approx 2 hours):
Caregiver only:
HRSD, QIDS-SR, STAI, PACQOL, PRD-III, UPT
Child only:
CASI, CDI, SCARED, PAQOL, ACT/cACT, Spirometry, PSS, Relatedness Scale
Both caregiver AND child:
CAMPCS
Week 52 (approx 2.5 hrs):
Caregiver only:
HRSD, QIDS-SR, STAI, PACQOL, PRD-III, UPT
Child only:
CASI, CDI, SCARED, PAQOL, ACT/cACT, Spirometry, PSS, Relatedness Scale
Both caregiver AND child:
CAMPCS, Debriefing interview
Electrocardiograms (ECG) and blood tests may be collected during this study as is clinically indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Interventional Longitudinal Study | Other | This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HRS-D) Change Scores | Change from Baseline in the caregiver's depression scores, as assessed by Hamilton Rating Scale for Depression (HRS-D). HRSD is a 17 item scale. Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22 | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
| Asthma Control Test (ACT) Change Scores | Change from Baseline in the child's asthma control scores, as indicated by increased Asthma Control Test (ACT) scores. ACT is a patient self-administered tool for identifying those with poorly controlled asthma. It is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
| Composite Asthma Severity Index (CASI) Change Scores | Change from Baseline in the child's asthma control scores, as indicated by decreased Composite Asthma Severity Index (CASI) scores. The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment and ranges from 0 to 20 points, with higher scores indicating higher levels of severity. | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
| Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores | Change from Baseline in the caregiver's depression scores, as assessed by Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR). The QIDS-SR is a validated 16-item self-report scale that assesses depressive symptom severity. Total QIDS-SR scores range from 0 to 27. Scores of ≤ 7 are considered normal, 8-12 suggest mild depressive symptoms, 13-16 moderate depressive symptoms, 17-20 moderate to severe depressive symptoms, and ≥ 21 severe depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Unscheduled Asthma-related Service Utilization Visits (Child) | Number of unscheduled asthma-related service utilization visits (i.e., clinic visits, ER visits, and hospitalizations) for the child participant at 52 weeks. | 52 weeks. |
| Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edson S Brown, M.D., PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458318 | Derived | Gwak DY, Tea JC, Fatima FN, Palka JM, Lehman H, Khan DA, Zhou H, Wood BL, Miller BD, Brown ES. Contribution of caregiver and child anxiety and depressive symptoms to child asthma-related quality of life. Ann Allergy Asthma Immunol. 2024 Sep;133(3):295-301. doi: 10.1016/j.anai.2024.02.026. Epub 2024 Mar 6. |
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Study participants included depressed caregivers and children with asthma, being treated at UT Southwestern (Dallas) and SUNY-Buffalo medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiver Child Dyad | Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver Child Dyad | This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study. |
| 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 | Hamilton Rating Scale for Depression (HRS-D) Change Scores | Change from Baseline in the caregiver's depression scores, as assessed by Hamilton Rating Scale for Depression (HRS-D). HRSD is a 17 item scale. Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22 | Posted | Mean | Standard Deviation | units on a scale | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
|
4 years, 4 months
Definitions do not differ from clinicaltrials.gov definitions.
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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 | Caregiver Child Dyad | This is a 52 week non-placebo controlled and non-randomized clinical research study to see whether treating Major Depressive Disorder (MDD) in caregivers of children with asthma will improve asthma outcomes in children. Caregivers may choose to receive an antidepressant medication that is considered standard medical care for MDD, or may opt out of antidepressant treatment. No treatment is withheld from participants and no placebos are used, thus there is no active intervention in this study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. E. Sherwood Brown | UT Southwestern Medical Center | 24-645-6950 | sherwood.brown@utsouthwestern.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 | Sep 8, 2021 | Oct 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Study followed caregivers and children for up to 12 months. They were given the option of algorithm-based antidepressant therapy using a variety of standard treatments. However, they could also receive medication or psychotherapy outside of the study, or decline all treatment.
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| From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
| Childhood Asthma Control Test (cACT) Change Scores | Change from Baseline in the child's asthma control scores, as indicated by increased Childhood Asthma Control Test (cACT) scores. Childhood Asthma Control Test (C-ACT) is well validated for use among children aged 4-11 years comprised of 3 parent-reported and 4 child-reported items. Possible scores range from 0 to 12, with higher scores indicating better asthma control. | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
Change from Baseline in child's quality of life scores on the Pediatric Asthma Quality of Life Questionnaire. Pediatric Asthma Quality of Life Questionnaire (PAQOL) measures problems that children experience as a result of their asthma. It has 23 questions in 3 domains (symptoms, activity limitation and emotional function). The activity domain contains 3 'patient-specific' questions. Children are asked to think about how they have been during the previous week and to respond to each of the 23 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered). Higher scores indicate better levels of functioning. This scale has proved a valid and reliable measure of asthma-specific quality of life in adolescents. Mean scores are reported, and range from 1 to 7. Higher score indicating higher quality of life. |
| From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
| Percent Change in Medication Adherence (Prescribed Inhalers) | Percent change in Medication Adherence (prescribed inhalers) was assessed by responses to items 4 (i.e., "The days that you took your controller medication in the last 7 days, about how much did you usually take each day?") and 5 (i.e., "How many days in the past 7 days did you take this controller medication?") from Childhood Asthma Management Program Continuation Study (CAMPCS) multiplied to determine how many puffs of the inhaled controller therapy were taken in the prior seven days. Following this, the product of items 4 and 5 was divided by the prescribed number of puffs per week (taken from RedCap). | Baseline, 52 weeks (1 year). |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Asthma Control Test (ACT) | ACT is a patient self-administered tool for identifying those with poorly controlled asthma. It is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Mean | Standard Deviation | units on a scale |
|
| Childhood Asthma Control Test (cACT) | Childhood Asthma Control Test (C-ACT) is well validated for use among children aged 4-11 years comprised of 3 parent-reported and 4 child-reported items. Possible scores range from 0 to 12, with higher scores indicating better asthma control. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Rating Scale for Depression (HRSD) | Caregiver depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HRSD) which is a 17 item scale. Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22 | Mean | Standard Deviation | units on a scale |
|
| Children's Depression Inventory-Short Form (CDI-SF) | 10-item CDI-S asks respondents to rate the severity of different symptoms of depression. Each item consists of three statements graded in order of increasing severity from 0 to 2. The item scores are combined into a total depression score, which ranges from 0 to 54, where higher scores indicate more depressive symptomatology (worse outcome). | Mean | Standard Deviation | units on a scale |
|
| Spirometry (FEV1%) | Mean | Standard Deviation | Percentage of FEV1 % predicted |
|
| Medication Adherence (prescribed inhalers) | Medication adherence was assessed as a percent of prescribed puffs children were adherent to at the Baseline assessment | Mean | Standard Deviation | Percentage of prescribed puffs |
|
|
|
| Primary | Asthma Control Test (ACT) Change Scores | Change from Baseline in the child's asthma control scores, as indicated by increased Asthma Control Test (ACT) scores. ACT is a patient self-administered tool for identifying those with poorly controlled asthma. It is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma. | Posted | Mean | Standard Deviation | units on a scale | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
|
|
|
| Primary | Composite Asthma Severity Index (CASI) Change Scores | Change from Baseline in the child's asthma control scores, as indicated by decreased Composite Asthma Severity Index (CASI) scores. The Composite Asthma Severity Index (CASI) is a comprehensive severity scale combining multiple facets of asthma severity: impairment, risk, and treatment and ranges from 0 to 20 points, with higher scores indicating higher levels of severity. | Posted | Mean | Standard Deviation | units on a scale | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
|
|
|
| Primary | Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores | Change from Baseline in the caregiver's depression scores, as assessed by Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR). The QIDS-SR is a validated 16-item self-report scale that assesses depressive symptom severity. Total QIDS-SR scores range from 0 to 27. Scores of ≤ 7 are considered normal, 8-12 suggest mild depressive symptoms, 13-16 moderate depressive symptoms, 17-20 moderate to severe depressive symptoms, and ≥ 21 severe depression. | Posted | Mean | Standard Deviation | units on a scale | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
|
|
|
| Primary | Childhood Asthma Control Test (cACT) Change Scores | Change from Baseline in the child's asthma control scores, as indicated by increased Childhood Asthma Control Test (cACT) scores. Childhood Asthma Control Test (C-ACT) is well validated for use among children aged 4-11 years comprised of 3 parent-reported and 4 child-reported items. Possible scores range from 0 to 12, with higher scores indicating better asthma control. | Posted | Mean | Standard Deviation | units on a scale | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
|
|
|
| Secondary | Number of Unscheduled Asthma-related Service Utilization Visits (Child) | Number of unscheduled asthma-related service utilization visits (i.e., clinic visits, ER visits, and hospitalizations) for the child participant at 52 weeks. | Posted | Number | Visitis | 52 weeks. |
|
|
|
| Secondary | Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores | Change from Baseline in child's quality of life scores on the Pediatric Asthma Quality of Life Questionnaire. Pediatric Asthma Quality of Life Questionnaire (PAQOL) measures problems that children experience as a result of their asthma. It has 23 questions in 3 domains (symptoms, activity limitation and emotional function). The activity domain contains 3 'patient-specific' questions. Children are asked to think about how they have been during the previous week and to respond to each of the 23 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered). Higher scores indicate better levels of functioning. This scale has proved a valid and reliable measure of asthma-specific quality of life in adolescents. Mean scores are reported, and range from 1 to 7. Higher score indicating higher quality of life. | Posted | Mean | Standard Deviation | units on a scale | From date of Baseline until the date of first documented progression, assessed up to 52 weeks. |
|
|
|
| Secondary | Percent Change in Medication Adherence (Prescribed Inhalers) | Percent change in Medication Adherence (prescribed inhalers) was assessed by responses to items 4 (i.e., "The days that you took your controller medication in the last 7 days, about how much did you usually take each day?") and 5 (i.e., "How many days in the past 7 days did you take this controller medication?") from Childhood Asthma Management Program Continuation Study (CAMPCS) multiplied to determine how many puffs of the inhaled controller therapy were taken in the prior seven days. Following this, the product of items 4 and 5 was divided by the prescribed number of puffs per week (taken from RedCap). | Posted | Mean | Standard Deviation | percent change | Baseline, 52 weeks (1 year). |
|
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|
| 0 |
| 205 |
| 0 |
| 205 |
| 46 |
| 205 |
| Infections | General disorders | Non-systematic Assessment |
|
| Nausea and/or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|