AsthmaNCT02809677
Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
A study testing Non-Interventional in people with Asthma and Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Asthma, Major Depressive Disorder
- What is being tested?
- Non-Interventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- A. requirement for treatment with daily controller medication; or
- B. symptoms of persistent asthma in children not on a daily controller medication:
- 1. Daytime symptoms two or more days per week; or
- 2. Rescue bronchodilator use two or more times per week; or
- 3. Nocturnal symptoms two or more nights per month; or
- 4. Two or more oral steroid bursts in the last year.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program
Dallas, Texas, 75235
About this study
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.
Read the 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:
- Structured Clinical Interview for DSM V (SCID)
- Urine Pregnancy Test (UPT) for women of child bearing potential
- Hamilton Rating Scale for Depression (HRSD)
- Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)
- State Trait Anxiety Inventory (STAI)
- Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQOL)
- Psychobiology of Recovery in Depression III Somatic Symptom Scale (PRD-III)
The following assessments will be given to the child:
- Composite Asthma Severity Index (CASI)
- Children's Depression Inventory (CDI)
- Screen for Child Anxiety Related Disorders (SCARED)
- Pediatric Asthma Quality of life Questionnaire (PAQOL)
- Asthma Control Test/Childhood Asthma Control Test (ACT/cACT) (which version is given will be determined by the child's age)
- Spirometry measurement
- Perceived Stress Scale (PSS)
- Relatedness Scale
The following assessments will be given to both the caregiver AND the child:
- 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.
- Conditions
- Asthma, Major Depressive Disorder
- Being tested
- Non-Interventional
- Medical subject headings
- Asthma, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
Secondary outcomes (3)
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.
Measured: 52 weeks.
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.
Measured: 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).
Measured: Baseline, 52 weeks (1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University at Buffalo
- Responsible party
- Principal investigator, Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center
- Investigators
- Edson S Brown, M.D., PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809677
- Sponsor's protocol ID
- STU 022014-069
- Other IDs
- 1R01HL123609-01A1
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2016
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38458318
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
- ClinicalTrials.gov ID
- NCT02809677
- Acronym / sponsor ID
- STU 022014-069
- Conditions
- Asthma, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University at Buffalo
- Study start
- Jun 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 15 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Structured Clinical Interview for DSM V (SCID)
- Urine Pregnancy Test (UPT) for women of child bearing potential
- Hamilton Rating Scale for Depression (HRSD)
- Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR)
- State Trait Anxiety Inventory (STAI)
- Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQOL)
- Psychobiology of Recovery in Depression III Somatic Symptom Scale (PRD-III)
The following assessments will be given to the child:
- Composite Asthma Severity Index (CASI)
- Children's Depression Inventory (CDI)
- Screen for Child Anxiety Related Disorders (SCARED)
- Pediatric Asthma Quality of life Questionnaire (PAQOL)
- Asthma Control Test/Childhood Asthma Control Test (ACT/cACT) (which version is given will be determined by the child's age)
- Spirometry measurement
- Perceived Stress Scale (PSS)
- Relatedness Scale
The following assessments will be given to both the caregiver AND the child:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Interventional Longitudinal Study | Other | Other: Non-InterventionalThis 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. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- A. requirement for treatment with daily controller medication; or
- B. symptoms of persistent asthma in children not on a daily controller medication:
- 1. Daytime symptoms two or more days per week; or
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalThis 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 Longitudinal Study |
Primary outcome
Hamilton Rating Scale for Depression (HRS-D) Change Scores
Time frame: 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
Asthma Control Test (ACT) Change Scores
Time frame: 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.
Composite Asthma Severity Index (CASI) Change Scores
Time frame: 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.
Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores
Time frame: 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.
Childhood Asthma Control Test (cACT) Change Scores
Time frame: 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.
3 secondary outcomes
Number of Unscheduled Asthma-related Service Utilization Visits (Child)
Time frame: 52 weeks.
Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores
Time frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
Percent Change in Medication Adherence (Prescribed Inhalers)
Time frame: Baseline, 52 weeks (1 year).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38458318Gwak 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.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edson S Brown, M.D., PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Interventional in people with Asthma and Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HRS-D) Change Scores (time frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.