Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Condition: Asthma; Major Depressive Disorder
MeSH terms: Asthma; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

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.
    

Intervention name(s): Non-Interventional
Intervention type(s): Other
Intervention description(s): 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 model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Diagnostic