Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02809677
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), University at Buffalo (Other)
• Enrollment: 205
• Location: 1
• Arm: 1
• Actual Duration (Months): 52
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Major Depressive Disorder	Other: Non-Interventional	N/A

Detailed Description

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:

• Obtaining demographic information

• Physical exam,

• Medical and psychiatric history

• Physical health assessments

• Urine Pregnancy Test for women of childbearing potential

• Mood assessments

The baseline visit is described below:

Baseline (approx 3 hrs):

The following assessments will be given to the Caregiver only:

1. Structured Clinical Interview for DSM V (SCID)

2. Urine Pregnancy Test (UPT) for women of child bearing potential

3. Hamilton Rating Scale for Depression (HRSD)

4. Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)

5. State Trait Anxiety Inventory (STAI)

6. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQOL)

7. Psychobiology of Recovery in Depression III Somatic Symptom Scale (PRD-III)

The following assessments will be given to the child:

1. Composite Asthma Severity Index (CASI)

2. Children's Depression Inventory (CDI)

3. Screen for Child Anxiety Related Disorders (SCARED)

4. Pediatric Asthma Quality of life Questionnaire (PAQOL)

5. Asthma Control Test/Childhood Asthma Control Test (ACT/cACT) (which version is given will be determined by the child's age)

6. Spirometry measurement

7. Perceived Stress Scale (PSS)

8. Relatedness Scale

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Other: Non-Interventional Longitudinal Study 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.

Other: Non-Interventional; 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.

Outcome Measures

Primary Outcome Measures

1. Hamilton Rating Scale for Depression (HRS-D) Change Scores [From date of Baseline until the date of first documented progression, assessed up to 52 weeks.]

   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

2. Asthma Control Test (ACT) Change Scores [From date of Baseline until the date of first documented progression, assessed up to 52 weeks.]

   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.

3. Composite Asthma Severity Index (CASI) Change Scores [From date of Baseline until the date of first documented progression, assessed up to 52 weeks.]

   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.

4. Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores [From date of Baseline until the date of first documented progression, assessed up to 52 weeks.]

   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.

5. Childhood Asthma Control Test (cACT) Change Scores [From date of Baseline until the date of first documented progression, assessed up to 52 weeks.]

   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.

Secondary Outcome Measures

1. Number of Unscheduled Asthma-related Service Utilization Visits (Child) [52 weeks.]

   Number of unscheduled asthma-related service utilization visits (i.e., clinic visits, ER visits, and hospitalizations) for the child participant at 52 weeks.

2. Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores [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.

3. Percent Change in Medication Adherence (Prescribed Inhalers) [Baseline, 52 weeks (1 year).]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Caregiver: Male or female, ages 18 to 70, primary asthma caregiver of the child, currently meeting criteria for Major Depressive Disorder (MDD) (based on depression symptoms for at least 2 weeks and causing clinically significant distress or impairment in social, occupational, or other important areas of functioning) based on a Structured Clinical Interview for DSM-4 (SCID) interview.

• Child: Male or female, ages 7-17 years who have a diagnosis of persistent asthma as classified by either of the following criteria:

• 1. requirement for treatment with daily controller medication; or
• 1. symptoms of persistent asthma in children not on a daily controller medication:
• 1. Daytime symptoms two or more days per week; or
• 1. Rescue bronchodilator use two or more times per week; or
• 1. Nocturnal symptoms two or more nights per month; or
• 1. Two or more oral steroid bursts in the last year.

Exclusion Criteria:

• Caregiver: Severe cognitive impairment that could impair their ability to provide informed consent; member of a vulnerable population (incarcerated, pregnant or breastfeeding women); women of childbearing age who will not use acceptable methods of birth control or abstinence during the study; severe psychiatric disorder in addition to MDD that should be a primary focus of treatment (e.g. severe and disabling eating or anxiety disorders); treatment refractory depression defined as failing ≥ 3 adequate trials of antidepressants (≥ 4 weeks at a therapeutic dose); electroconvulsive therapy or repeated transcranial magnetic stimulation during the current episode; depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to substances or general medical condition, or with psychotic features or accompanied by severe obsessive compulsive disorder (OCD), or high risk for suicide defined by multiple recent suicide attempts (> 2 in the past year) or any attempt in the past month, or current suicidal ideation with a well-formed plan or intent.

• Child: Severe cognitive impairment that could impair their ability to provide informed consent; high risk for suicide defined by multiple recent suicide attempts (> 2 in the past year) or any attempt in the past month, or current suicidal ideation with a well-formed plan or intent; severe or life-threatening medical illness, such as other serious cardiopulmonary conditions (e.g. congenital heart disease, cystic fibrosis, alpha-1-antitrypsin disease) or cancer, which would confound the assessment of asthma, anxiety, depression or quality of life; severe psychiatric illness, such as autism, bipolar disorder, schizophrenia or current drug/alcohol abuse/dependence. If an eligible caregiver presents with more than one child meeting inclusion criteria for the study, only one child, randomly selected, will be enrolled.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program	Dallas	Texas	United States	75235

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• National Heart, Lung, and Blood Institute (NHLBI)
• University at Buffalo

Investigators

• Principal Investigator: Edson S Brown, M.D., PhD, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 8, 2021

More Information

Publications

None provided.

• Responsible Party: Sherwood Brown, MD, PhD, Professor of Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02809677
• Other Study ID Numbers: 022014-069; 1R01HL123609-01A1
• First Posted: Jun 22, 2016
• Last Update Posted: Feb 15, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Asthma; Depressive Disorder; Depressive Disorder, Major

Study Results

Participant Flow

Recruitment Details	Study participants included depressed caregivers and children with asthma, being treated at UT Southwestern (Dallas) and SUNY-Buffalo medical centers.

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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.
Period Title: Overall Study
STARTED	205
COMPLETED	197
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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.
Overall Participants	205
Age (Years) [Mean (Standard Deviation) ]
Caregiver	38.62 (7.95)
Child	11.31 (2.89)
Sex: Female, Male (Count of Participants)
Female	201 98%
Male	4 2%
Female	111 54.1%
Male	94 45.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	65 31.7%
Not Hispanic or Latino	134 65.4%
Unknown or Not Reported	6 2.9%
Hispanic or Latino	65 31.7%
Not Hispanic or Latino	132 64.4%
Unknown or Not Reported	8 3.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 2%
Asian	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	107 52.2%
White	81 39.5%
More than one race	12 5.9%
Unknown or Not Reported	0 0%
American Indian or Alaska Native	2 1%
Asian	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	116 56.6%
White	71 34.6%
More than one race	12 5.9%
Unknown or Not Reported	3 1.5%
Region of Enrollment (participants) [Number]
United States	205 100%
Asthma Control Test (ACT) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.78 (4.89)
Childhood Asthma Control Test (cACT) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.47 (4.64)
Hamilton Rating Scale for Depression (HRSD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.95 (4.79)
Children's Depression Inventory-Short Form (CDI-SF) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.50 (6.36)
Spirometry (FEV1%) (Percentage of FEV1 % predicted) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of FEV1 % predicted]	73.79 (38.11)
Medication Adherence (prescribed inhalers) (Percentage of prescribed puffs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of prescribed puffs]	72.17 (31.45)

Outcome Measures

1. Primary Outcome

Title	Hamilton Rating Scale for Depression (HRS-D) Change Scores
Description	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
Time Frame	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [units on a scale]	-8.39 (7.37)

2. Primary Outcome

Title	Asthma Control Test (ACT) Change Scores
Description	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.
Time Frame	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [units on a scale]	2.71 (4.80)

3. Primary Outcome

Title	Composite Asthma Severity Index (CASI) Change Scores
Description	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.
Time Frame	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [units on a scale]	-1.43 (2.74)

4. Primary Outcome

Title	Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores
Description	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.
Time Frame	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [units on a scale]	-7.12 (5.55)

5. Primary Outcome

Title	Childhood Asthma Control Test (cACT) Change Scores
Description	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.
Time Frame	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [units on a scale]	0.93 (2.63)

6. Secondary Outcome

Title	Number of Unscheduled Asthma-related Service Utilization Visits (Child)
Description	Number of unscheduled asthma-related service utilization visits (i.e., clinic visits, ER visits, and hospitalizations) for the child participant at 52 weeks.
Time Frame	52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Unscheduled Clinic Visits	70
ER Visits	48
Hospitalizations	17

7. Secondary Outcome

Title	Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores
Description	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.
Time Frame	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [units on a scale]	0.85 (1.92)

8. Secondary Outcome

Title	Percent Change in Medication Adherence (Prescribed Inhalers)
Description	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).
Time Frame	Baseline, 52 weeks (1 year).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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 Participants	197
Mean (Standard Deviation) [percent change]	13 (41)

Adverse Events

Time Frame	4 years, 4 months
Adverse Event Reporting Description	Definitions do not differ from clinicaltrials.gov definitions.
Arm/Group Title	Caregiver Child Dyad
Arm/Group Description	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.
All Cause Mortality
	Caregiver Child Dyad
	Affected / at Risk (%)	# Events
Total	0/205 (0%)
Serious Adverse Events
	Caregiver Child Dyad
	Affected / at Risk (%)	# Events
Total	0/205 (0%)
Other (Not Including Serious) Adverse Events
	Caregiver Child Dyad
	Affected / at Risk (%)	# Events
Total	46/205 (22.4%)
Gastrointestinal disorders
Nausea and/or vomiting	14/205 (6.8%)	14
General disorders
Headache	11/205 (5.4%)	11
Infections	21/205 (10.2%)	21

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.