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Impact of Caregiver Depression on Asthma in the Child

Primary Purpose

Depressive Disorder, Major, Asthma

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Lexapro
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old Male and female English or Spanish Speaking Between the ages of 18 and 70 years old Caregivers with major depressive disorder will be offered treatment Exclusion Criteria: At risk for suicide defined by multiple suicide attempts (greater than or equal to 3 in the past), and/or current suicidal ideation with a well-formed plan or intent Unlikely to attend follow-up appointments Mentally retarded or suffer from other severe cognitive impairment Pregnant or nursing, or women of childbearing age who will not use methods of birth control or abstinence during the study Suffering from a severe or life-threatening medical illness which would make completion of the study unlikely Suffering from treatment refractory depression defined by failing three adequate trials of antidepressants Depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to a medication or general medical condition, or with psychotic features

Sites / Locations

  • The University of Texas Southwestern Medical Center at Dallas

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 15, 2005
Last Updated
August 2, 2011
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00223288
Brief Title
Impact of Caregiver Depression on Asthma in the Child
Official Title
Caregiver Psychiatric Symptomatology and it's Relationship to Service Utilization by Children With Asthma
Study Type
Observational

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

5. Study Description

Brief Summary
This study will examine if depression in a primary caregiver is associated with more hospitalization or ER visits in children with asthma. This study will also explore whether treatment for depression in the primary caregivers is associated with improvement in asthma in school-aged children. Asthma is a very common childhood disorder of airway inflammation. The causes include environmental irritants, cold temperature, and infection in the respiratory tract, and emotional factors can contribute to symptom exacerbation. However, asthma is a disease that can be well controlled if there is proper medication compliance and careful control of environmental conditions. Data suggests that psychiatric symptoms in the mothers of children with asthma are associated with more asthma related hospitalizations in children. Thus, we want to explore this question further using more specific diagnostic instruments in order to detect what types of symptoms are associated with increased asthma related service utilization. Also, we want to explore if effective treatment of the caregivers' symptoms is associated with decreased hospitalization and emergency room visits for the child.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Asthma

7. Study Design

Enrollment
175 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lexapro

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria: Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old Male and female English or Spanish Speaking Between the ages of 18 and 70 years old Caregivers with major depressive disorder will be offered treatment Exclusion Criteria: At risk for suicide defined by multiple suicide attempts (greater than or equal to 3 in the past), and/or current suicidal ideation with a well-formed plan or intent Unlikely to attend follow-up appointments Mentally retarded or suffer from other severe cognitive impairment Pregnant or nursing, or women of childbearing age who will not use methods of birth control or abstinence during the study Suffering from a severe or life-threatening medical illness which would make completion of the study unlikely Suffering from treatment refractory depression defined by failing three adequate trials of antidepressants Depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to a medication or general medical condition, or with psychotic features
Study Population Description
Primary caregiver of a child currently hospitalized at Children's Medical Center of Dallas for an asthma exacerbation and between the ages of 5 and 16 years old
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Sherwood Brown, MD, Ph.D.
Organizational Affiliation
University of Texas, Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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Impact of Caregiver Depression on Asthma in the Child

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