Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

NCT02809677 | Completed Results DMC

• 2 other identifiers: STU 022014-0691R01HL123609-01A1
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Major Depressive Disorder

Outcome Measures

Primary Outcomes (5)

• Hamilton Rating Scale for Depression (HRS-D) Change Scores

  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

  From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

• Asthma Control Test (ACT) Change Scores

  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.

  From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

• Composite Asthma Severity Index (CASI) Change Scores

  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.

  From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

• Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores

  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.

  From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

• Childhood Asthma Control Test (cACT) Change Scores

  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.

  From date of Baseline until the date of first documented progression, assessed up to 52 weeks.

Secondary Outcomes (3)

• 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).

Study Arms (1)

Non-Interventional Longitudinal Study

OTHER

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.

Other: Non-Interventional

Interventions

Non-Interventional OTHER

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.

Non-Interventional Longitudinal Study

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Daytime symptoms two or more days per week; or
• \. Rescue bronchodilator use two or more times per week; or
• \. Nocturnal symptoms two or more nights per month; or
• \. Two or more oral steroid bursts in the last year.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University at Buffalo: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Gwak DY, Tea JC, Fatima FN, Palka JM, Lehman H, Khan DA, Zhou H, Wood BL, Miller BD, Brown ES. Contribution of caregiver and child anxiety and depressive symptoms to child asthma-related quality of life. Ann Allergy Asthma Immunol. 2024 Sep;133(3):295-301. doi: 10.1016/j.anai.2024.02.026. Epub 2024 Mar 6.

  PMID: 38458318 DERIVED

MeSH Terms

Conditions

Asthma; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. E. Sherwood Brown
• Organization: UT Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

24-645-6950

Study Officials

• Edson S Brown, M.D., PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 24, 2025
• Results First Posted: February 15, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)