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Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809677
Recruitment Status : Active, not recruiting
First Posted : June 22, 2016
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University at Buffalo
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE June 22, 2016
Last Update Posted Date May 19, 2020
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • Change from Baseline in the caregiver's depression scores, as assessed by Hamilton Rating Scale for Depression (HRS-D). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • Change from Baseline in the number of unscheduled asthma-related service utilization visits for the child participant at 52 weeks. [ Time Frame: 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. [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  • Relationship between caregiver's medication adherence and child depression scorers, as assessed by the Child Depression Inventory (CDI). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
  • Relationship between caregiver's antidepressant medication adherence and child anxiety scorers, as assessed by the Screen for Child Anxiety Disorders (SCARED). [ Time Frame: From date of Baseline until the date of first documented progression, assessed up to 52 weeks. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
Official Title  ICMJE Treating Caregiver Depression to Improve Childhood Asthma: Impact and Mediators
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Asthma
  • Major Depressive Disorder
Intervention  ICMJE
  • Drug: Escitalopram
    Escitalopram (ESC) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 5mg PO QD for 4 weeks. Increase to 10mg PO QD at Week 4 (if needed). Increase to 20mg PO QD at Week 8 (if needed).
    Other Name: Lexapro
  • Drug: Venlafaxine XR
    Venlafaxine Extended Release (VEN XR) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 75mg PO QD for 4 weeks. Increase at Week 4 to 150mg PO QD (if needed). Increase at Week 8 to 300mg PO QD (if needed).
    Other Name: Effexor
  • Drug: Bupropion XR
    Bupropion Extended Release (BUP XR) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 150mg PO QD for 4 weeks. Increase at Week 4 to 300mg PO QD (if needed). Increase at Week 8 to 450mg PO QD (if needed).
    Other Name: Wellbutrin
  • Drug: Sertraline
    Sertraline (SERT) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 50mg PO QD for 4 weeks. Increase at Week 4 to 100mg PO QD (if needed). Increase at Week 8 to 200mg PO QD (if needed).
    Other Name: Zoloft
  • Drug: Mirtazapine
    Mirtazapine (MIRT) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 15mg PO qHS for 4 weeks. Increase at Week 4 to 30mg PO qHS (if needed). Increase at Week 8 to 45mg PO qHS (if needed).
    Other Name: Remeron
  • Drug: Buspirone

    Buspirone (BUSP) as an augmenting agent for the Major Depressive Disorder (MDD).

    Dose titration schedule: begin at Week 24 of the study (if needed) at 10mg PO QD for 3 days, then 10mg PO BID for 4 weeks. Increase at Week 28 (if needed) to 15mg PO BID. Increase at Week 32 (if needed) to 20mg PO BID.

    Other Name: Buspar
  • Drug: Quetiapine

    Quetiapine (QUET) as an augmenting agent for the Major Depressive Disorder (MDD).

    Dose titration schedule: begin at Week 24 of the study (if needed) at 25mg PO qHS for 4 weeks. Increase at Week 28 (if needed) to 50mg PO qHS. Increase at Week 32 (if needed) to 100mg PO qHS.

    Other Name: Seroquel
  • Drug: Aripiprazole
    Aripiprazole as an augmenting agent for the Major Depressive Disorder (MDD) for non-response patients at Week 48 of study. Dose titration schedule: begin at Week 48 (if needed) at 2mg PO QD for 4 weeks.
    Other Name: Abilify
  • Drug: Lithium
    Lithium as an augmenting agent for the Major Depressive Disorder (MDD) for non-response patients at Week 48 of study. Dose titration schedule: begin at Week 48 (if needed) at 300mg PO qHS for 4 weeks.
    Other Name: Lithobid
Study Arms  ICMJE 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.
Interventions:
  • Drug: Escitalopram
  • Drug: Venlafaxine XR
  • Drug: Bupropion XR
  • Drug: Sertraline
  • Drug: Mirtazapine
  • Drug: Buspirone
  • Drug: Quetiapine
  • Drug: Aripiprazole
  • Drug: Lithium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2016)
196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Child: Severe cognitive impairment that could impair their ability to provide informed consent; 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; severe or life-threatening medical illness, such as other serious cardiopulmonary conditions (e.g. congenital heart disease, cystic fibrosis, alpha-1-antitrypsin disease) or cancer, which would confound the assessment of asthma, anxiety, depression or quality of life; severe psychiatric illness, such as autism, bipolar disorder, schizophrenia or current drug/alcohol abuse/dependence. If an eligible caregiver presents with more than one child meeting inclusion criteria for the study, only one child, randomly selected, will be enrolled.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02809677
Other Study ID Numbers  ICMJE 022014-069
1R01HL123609-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University at Buffalo
Investigators  ICMJE
Principal Investigator: Edson S Brown, M.D., PhD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP