Trial Outcomes & Findings for Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators (NCT NCT02809677)

Last Updated: 2025-09-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

205 participants

Primary outcome timeframe

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

Results posted on

2025-09-24

Participant Flow

Study participants included depressed caregivers and children with asthma, being treated at UT Southwestern (Dallas) and SUNY-Buffalo medical centers.

Participant milestones

Participant milestones
Measure	Caregiver Child Dyad 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.
Overall Study STARTED	205
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Caregiver Child Dyad 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.
Overall Study Withdrawal by Subject	8

Baseline Characteristics

Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caregiver Child Dyad n=205 Participants 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.
Age, Continuous Caregiver	38.62 Years STANDARD_DEVIATION 7.95 • n=5 Participants
Age, Continuous Child	11.31 Years STANDARD_DEVIATION 2.89 • n=5 Participants
Sex: Female, Male Caregiver · Female	201 Participants n=5 Participants
Sex: Female, Male Caregiver · Male	4 Participants n=5 Participants
Sex: Female, Male Child · Female	111 Participants n=5 Participants
Sex: Female, Male Child · Male	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Caregiver · Hispanic or Latino	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Caregiver · Not Hispanic or Latino	134 Participants n=5 Participants
Ethnicity (NIH/OMB) Caregiver · Unknown or Not Reported	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Child · Hispanic or Latino	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Child · Not Hispanic or Latino	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Child · Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) Caregiver · American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Caregiver · Asian	1 Participants n=5 Participants
Race (NIH/OMB) Caregiver · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Caregiver · Black or African American	107 Participants n=5 Participants
Race (NIH/OMB) Caregiver · White	81 Participants n=5 Participants
Race (NIH/OMB) Caregiver · More than one race	12 Participants n=5 Participants
Race (NIH/OMB) Caregiver · Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) Child · American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Child · Asian	1 Participants n=5 Participants
Race (NIH/OMB) Child · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Child · Black or African American	116 Participants n=5 Participants
Race (NIH/OMB) Child · White	71 Participants n=5 Participants
Race (NIH/OMB) Child · More than one race	12 Participants n=5 Participants
Race (NIH/OMB) Child · Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	205 participants n=5 Participants
Asthma Control Test (ACT)	17.78 units on a scale STANDARD_DEVIATION 4.89 • n=5 Participants
Childhood Asthma Control Test (cACT)	17.47 units on a scale STANDARD_DEVIATION 4.64 • n=5 Participants
Hamilton Rating Scale for Depression (HRSD)	17.95 units on a scale STANDARD_DEVIATION 4.79 • n=5 Participants
Children's Depression Inventory-Short Form (CDI-SF)	9.50 units on a scale STANDARD_DEVIATION 6.36 • n=5 Participants
Spirometry (FEV1%)	73.79 Percentage of FEV1 % predicted STANDARD_DEVIATION 38.11 • n=5 Participants
Medication Adherence (prescribed inhalers)	72.17 Percentage of prescribed puffs STANDARD_DEVIATION 31.45 • n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Hamilton Rating Scale for Depression (HRS-D) Change Scores	-8.39 units on a scale Standard Deviation 7.37

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Asthma Control Test (ACT) Change Scores	2.71 units on a scale Standard Deviation 4.80

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Composite Asthma Severity Index (CASI) Change Scores	-1.43 units on a scale Standard Deviation 2.74

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) Change Scores	-7.12 units on a scale Standard Deviation 5.55

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Childhood Asthma Control Test (cACT) Change Scores	0.93 units on a scale Standard Deviation 2.63

SECONDARY outcome

Timeframe: 52 weeks.

Number of unscheduled asthma-related service utilization visits (i.e., clinic visits, ER visits, and hospitalizations) for the child participant at 52 weeks.

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Number of Unscheduled Asthma-related Service Utilization Visits (Child) Unscheduled Clinic Visits	70 Visitis
Number of Unscheduled Asthma-related Service Utilization Visits (Child) ER Visits	48 Visitis
Number of Unscheduled Asthma-related Service Utilization Visits (Child) Hospitalizations	17 Visitis

SECONDARY outcome

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

Change from Baseline in child's quality of life scores on the Pediatric Asthma Quality of Life Questionnaire. Pediatric Asthma Quality of Life Questionnaire (PAQOL) measures problems that children experience as a result of their asthma. It has 23 questions in 3 domains (symptoms, activity limitation and emotional function). The activity domain contains 3 'patient-specific' questions. Children are asked to think about how they have been during the previous week and to respond to each of the 23 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered). Higher scores indicate better levels of functioning. This scale has proved a valid and reliable measure of asthma-specific quality of life in adolescents. Mean scores are reported, and range from 1 to 7. Higher score indicating higher quality of life.

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Pediatric Asthma Quality of Life Questionnaire (PAQOL) Change Scores	0.85 units on a scale Standard Deviation 1.92

SECONDARY outcome

Timeframe: Baseline, 52 weeks (1 year).

Percent change in Medication Adherence (prescribed inhalers) was assessed by responses to items 4 (i.e., "The days that you took your controller medication in the last 7 days, about how much did you usually take each day?") and 5 (i.e., "How many days in the past 7 days did you take this controller medication?") from Childhood Asthma Management Program Continuation Study (CAMPCS) multiplied to determine how many puffs of the inhaled controller therapy were taken in the prior seven days. Following this, the product of items 4 and 5 was divided by the prescribed number of puffs per week (taken from RedCap).

Outcome measures

Outcome measures
Measure	Caregiver Child Dyad n=197 Participants 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.
Percent Change in Medication Adherence (Prescribed Inhalers)	13 percent change Standard Deviation 41

Adverse Events

Caregiver Child Dyad

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Caregiver Child Dyad n=205 participants at risk 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.
General disorders Headache	5.4% 11/205 • Number of events 11 • 4 years, 4 months Definitions do not differ from clinicaltrials.gov definitions.
General disorders Infections	10.2% 21/205 • Number of events 21 • 4 years, 4 months Definitions do not differ from clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea and/or vomiting	6.8% 14/205 • Number of events 14 • 4 years, 4 months Definitions do not differ from clinicaltrials.gov definitions.

Additional Information

Dr. E. Sherwood Brown

UT Southwestern Medical Center

Phone: 24-645-6950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place