Clinical trial NCT02809677: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Major Depressive Disorder
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University at Buffalo
First posted: 2016-06-22
Enrollment: 205
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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:

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.

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.

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HRS-D) Change Scores
timeFrame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
measure: Asthma Control Test (ACT) Change Scores
timeFrame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
measure: Composite Asthma Severity Index (CASI) Change Scores
timeFrame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
measure: Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores
timeFrame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
measure: Childhood Asthma Control Test (cACT) Change Scores
timeFrame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
Secondary outcomes:
measure: Number of Unscheduled Asthma-related Service Utilization Visits (Child)
timeFrame: 52 weeks.
measure: Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores
timeFrame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks.
measure: Percent Change in Medication Adherence (Prescribed Inhalers)
timeFrame: Baseline, 52 weeks (1 year).
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Edson S Brown, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: