NCT00223288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

2.9 years

First QC Date

September 15, 2005

Last Update Submit

August 2, 2011

Conditions

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorAsthma

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • E. Sherwood Brown, MD, Ph.D.

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

March 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations