Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression (HRS-D) Change Scores
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hamilton Rating Scale for Depression (HRS-D) Change Scores
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Number of Unscheduled Asthma-related Service Utilization Visits (Child)(52 weeks.)
- Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores(From date of Baseline until the date of first documented progression, assessed up to 52 weeks.)
- Percent Change in Medication Adherence (Prescribed Inhalers)(Baseline, 52 weeks (1 year).)
研究者
Sherwood Brown, MD, PhD
Professor of Medicine
University of Texas Southwestern Medical Center