Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

NCT ID: NCT02809677

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-10-31

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.

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.

Conditions

Asthma; Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Non-Interventional Longitudinal Study

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.

Group Type: OTHER

Non-Interventional

Intervention Type: 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.

Interventions

Non-Interventional

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherwood Brown, MD, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edson S Brown, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center Psychoneuroendocrine Research Program

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38458318 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01HL123609-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 022014-069

Identifier Type: -

Identifier Source: org_study_id