Back to resultsTreating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Primary Purpose
Asthma, Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-Interventional
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma
Eligibility Criteria
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:
- 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.
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.
Sites / Locations
- University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Non-Interventional Longitudinal Study
Arm 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.
Outcomes
Primary Outcome Measures
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
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT02809677
First Posted
April 11, 2016
Last Updated
January 24, 2022
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT02809677
Brief Title
Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Official Title
Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University at Buffalo
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Major Depressive Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Interventional Longitudinal Study
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Non-Interventional
Intervention 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.
Primary Outcome Measure Information:
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.
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.
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.
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.
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.
Secondary Outcome Measure Information:
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.
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.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edson S Brown, M.D., PhD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
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