N/A
Completed N=205
Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Source: ClinicalTrials.gov NCT02809677 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Hamilton Rating Scale for Depression (HRS-D) Change Scores — -8.39 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scale for Depression (HRS-D) Change Scores |
-8.39 | — |
| PRIMARY Asthma Control Test (ACT) Change Scores |
2.71 | — |
| PRIMARY Composite Asthma Severity Index (CASI) Change Scores |
-1.43 | — |
| PRIMARY Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores |
-7.12 | — |
| PRIMARY Childhood Asthma Control Test (cACT) Change Scores |
0.93 | — |
| SECONDARY Number of Unscheduled Asthma-related Service Utilization Visits (Child) |
70; 48; 17 | — |
| SECONDARY Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores |
0.85 | — |
| SECONDARY Percent Change in Medication Adherence (Prescribed Inhalers) |
13 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02809677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.