Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

Asthma Clinical Trial

Official title:

Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809677
• Other study ID #: 022014-069
• Secondary ID: 1R01HL123609-01A
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 2020

Study information

• Verified date: January 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program	Dallas	Texas

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
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.	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.	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.	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.	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.	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.	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).	Baseline, 52 weeks (1 year).