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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.
Full 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:
The baseline visit is described below:
Baseline (approx 3 hrs):
The following assessments will be given to the Caregiver only:
The following assessments will be given to the child:
The following assessments will be given to both the caregiver AND the child:
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.
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205 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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