Asthma in ChildrenNCT06623981
The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
A study testing Enhanced Brief Interpersonal Psychotherapy in people with Asthma in Children and Depression, run by Children's National Research Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children under the age of 18 in an urban pediatric asthma clinic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma in Children, Depression
- What is being tested?
- Enhanced Brief Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Maternal:
- Primary caregiver of the child with asthma seen at the community-based asthma clinic
- Female (self-identified)
- Black (self-identified)
- ≥ 18 years of age
- English-speaking
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- PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit
- Child:
- <18 years old for the duration of the 6-month study period
- Publicly insured
- Physician-diagnosed persistent asthma
Who cannot join
- Maternal:
- Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)
- Bipolar disorder or mania
- Schizophrenia
- Current substance abuse/dependence
- Current serious physical intimate partner violence (IPV)
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- Lack of capacity to meaningfully participate in study procedures, as assessed by study staff during screening
- Child:
- Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease)
- Enrolled in another intervention with a behavioral component and/or novel asthma therapeutics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Geraldine Mendez-Gonzalez, 202-476-6956, GMENDEZGON@childrensnational.org
Rachel Margolis, PhD, MSW
About this study
Official title: Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic
The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children under the age of 18 in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are:
- Does Enhanced IPT-B decrease maternal depressive symptoms?
- Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)?
- What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?
Read the detailed description
The purpose of the study is to determine the effectiveness and implementation of Brief Enhanced Interpersonal Psychotherapy (IPT-B), an evidence-based treatment for maternal depression, delivered in an urban pediatric asthma clinic. This study is a pilot Hybrid Type 1 Effectiveness-Implementation, single-blinded, prospective randomized controlled trial. A parallel two-group design will be used to evaluate the impact of the intervention (Enhanced IPT-B) among a sample of 48 Black mothers of children under the age of 18 with asthma. Mothers with PHQ-9 ≥ 8 will be identified in the asthma clinic through routine depression screening during the child's visit and recruited to participate in the study if they meet eligibility criteria. Following the informed consent process, mothers randomized to the intervention group will receive Enhanced IPT-B. Enhanced IPT-B consists of a single, 45-60-minute pre-treatment engagement session followed by eight weekly, 45-minute individual psychotherapy sessions carried out by a licensed mental health clinician within an 8-12-week timeframe. Mothers randomized to the comparison group will receive Supplemented Usual Care which involves short-term care coordination to access community mental health resources. Data on maternal mental health, child asthma management and outcomes, and child mental health will be collected from mothers and children at baseline, 3 months post-baseline, and 6 months post-baseline. Data on implementation outcomes will be collected from mothers and asthma clinic leadership and staff. Quantitative and qualitative data analysis strategies will be utilized to answer the research questions.
- Conditions
- Asthma in Children, Depression
- Being tested
- Enhanced Brief Interpersonal Psychotherapy, Supplemented Usual Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Brief Interpersonal PsychotherapyBehavioural
Enhanced IPT-B consists of a single, 45-60-minute pre-treatment engagement session followed by eight weekly, 45-minute individual sessions carried out within an 8-12-week timeframe.
Supplemented Usual CareBehavioural
Usual care for caregivers with depressive symptoms involves the asthma clinic physician discussing the PHQ-9 results with the caregiver, providing brief psychoeducation on depression and giving the caregiver a written list of mental health resources. Usual care will be supplemented by providing short-term care coordination. Care coordination will involve assisting the participant in calling a mental health clinic to make an appointment and one follow-up phone call within two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced IPT-B | Experimental | Enhanced Brief Interpersonal Psychotherapy Receives: Behavioral: Enhanced Brief Interpersonal Psychotherapy |
| Supplemented Usual Care | Active comparator | Short-term care coordination Receives: Behavioral: Supplemented Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal depressive symptoms
≥ 50% reduction in depressive symptoms on the 9-item Patient Health Questionnaire (PHQ-9) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. This variable will be dichotomized into 50% or greater reduction in depressive symptoms vs. less than 50% reduction in depressive symptoms from T1 to T2.
Measured: T2 (3 months post-baseline)
Secondary outcomes (15)
Clinically significant maternal depressive symptoms
9-item Patient Health Questionnaire (PHQ-9) score less than 10 (i.e., not clinically significant) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. A score of 10 or more indicates clinically significant symptoms. This variable will be dichotomized into clinically significant and not clinically significant.
Measured: T2 (3 months post-baseline)
Child asthma exacerbations
Number of asthma exacerbations requiring steroids in the past 6 months
Measured: T3 (6 months post-baseline)
Child asthma symptoms
Mother-reported number of child asthma symptom-free days during the prior 14 days
Measured: T2 (3 months post-baseline), T3 (6 months post-baseline)
Maintenance
Percentage of enrolled mothers who remain in the study
Measured: T3 (6 months post-baseline)
Acceptability
Mean treatment satisfaction survey score on the Client Satisfaction Questionnaire
Measured: T2 (3 months post-baseline)
Maternal anxiety symptoms
Scores on the 7-item Generalized Anxiety Disorder sale (GAD-7). Scores range from 0-21, with higher scores indicating more anxiety.
Measured: T2 (3-months post-baseline) and T3 (6months post-baseline)
Maternal PTSD symptoms
Score on the PTSD Checklist for DSM-5 (PCL-5), a validated self-report measure of PTSD symptoms in adults. Scores on the PCL-5 range from 0-80, with higher scores indicating more PTSD symptoms.
Measured: T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child depressive symptoms
Mother report of child depressive symptoms on the PROMIS Parent Proxy Depressive Symptoms v3.0- Short Form 6a. Raw scores on the measure range from 6-30, with higher scores indicating more depressive symptoms.
Measured: T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child anxiety symptoms
Mother report of child anxiety symptoms on the PROMIS Parent Proxy Short Form GenPop v3.0 - Anxiety 8a. Raw scores on the measure range from 8-40, with higher scores indicating more anxiety symptoms.
Measured: T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child asthma control
Dichotomized score on the Child Asthma Control Test where ACT ≥ 20 indicates controlled asthma and ACT less than 20 indicates uncontrolled asthma.
Measured: T2 (3 months post-baseline), T3 (6 months post-baseline)
Asthma management
Summary score on the Family Asthma Management System Scale (FAMSS), a clinical interview that assesses how well the family system manages the asthma of the child. The interview is recorded and rated on eight 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management.
Measured: T2 (3 months post-baseline)
Reach
The number and proportion of eligible mothers recruited into the study
Measured: T1 (Baseline)
Feasibility
Percentage of mothers who complete at least 7 sessions of the intervention (Enhanced IPT-B)
Measured: T2 (3 months post-baseline)
Satisfaction
Semi-structured interviews will be conducted with at least one third of Enhanced IPT-B participants to assess intervention satisfaction.
Measured: T3 (6 months post-baseline)
Staff-reported implementation outcomes
Semi-structure qualitative interviews with asthma clinic staff and leadership to assess adoption, acceptability, and maintenance of the intervention.
Measured: At the end of year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 Oct 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Rachel Margolis, PhD, MSW, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623981
- Sponsor's protocol ID
- STUDY00001112
- Other IDs
- K01MD018636
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual and aggregate survey data (including raw and recoded data) will be shared. The data from intervention sessions with Enhanced IPT-B participants will not be shared. Summarized aggregated deidentified data from the implementation-focused process evaluation will be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic
- ClinicalTrials.gov ID
- NCT06623981
- Acronym / sponsor ID
- STUDY00001112
- Conditions
- Asthma in Children, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children under the age of 18 in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are:
- Does Enhanced IPT-B decrease maternal depressive symptoms?
- Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)?
- What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?
Detailed description
The purpose of the study is to determine the effectiveness and implementation of Brief Enhanced Interpersonal Psychotherapy (IPT-B), an evidence-based treatment for maternal depression, delivered in an urban pediatric asthma clinic. This study is a pilot Hybrid Type 1 Effectiveness-Implementation, single-blinded, prospective randomized controlled trial. A parallel two-group design will be used to evaluate the impact of the intervention (Enhanced IPT-B) among a sample of 48 Black mothers of children under the age of 18 with asthma. Mothers with PHQ-9 ≥ 8 will be identified in the asthma clinic through routine depression screening during the child's visit and recruited to participate in the study if they meet eligibility criteria. Following the informed consent process, mothers randomized to the intervention group will receive Enhanced IPT-B. Enhanced IPT-B consists of a single, 45-60-minute pre-treatment engagement session followed by eight weekly, 45-minute individual psychotherapy sessions carried out by a licensed mental health clinician within an 8-12-week timeframe. Mothers randomized to the comparison group will receive Supplemented Usual Care which involves short-term care coordination to access community mental health resources. Data on maternal mental health, child asthma management and outcomes, and child mental health will be collected from mothers and children at baseline, 3 months post-baseline, and 6 months post-baseline. Data on implementation outcomes will be collected from mothers and asthma clinic leadership and staff. Quantitative and qualitative data analysis strategies will be utilized to answer the research questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced IPT-B | Experimental | Behavioral: Enhanced Brief Interpersonal PsychotherapyEnhanced Brief Interpersonal Psychotherapy |
| Supplemented Usual Care | Active comparator | Behavioral: Supplemented Usual CareShort-term care coordination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Primary caregiver of the child with asthma seen at the community-based asthma clinic
- Female (self-identified)
- Black (self-identified)
- ≥ 18 years of age
- English-speaking
Key exclusion criteria (10 listed)
- Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)
- Bipolar disorder or mania
- Schizophrenia
- Current substance abuse/dependence
- Current serious physical intimate partner violence (IPV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Brief Interpersonal PsychotherapyEnhanced IPT-B consists of a single, 45-60-minute pre-treatment engagement session followed by eight weekly, 45-minute individual sessions carried out within an 8-12-week timeframe. | Behavioural | Enhanced IPT-B |
| Supplemented Usual CareUsual care for caregivers with depressive symptoms involves the asthma clinic physician discussing the PHQ-9 results with the caregiver, providing brief psychoeducation on depression and giving the caregiver a written list of mental health resources. Usual care will be supplemented by providing short-term care coordination. Care coordination will involve assisting the participant in calling a mental health clinic to make an appointment and one follow-up phone call within two weeks. | Behavioural | Supplemented Usual Care |
Primary outcome
Maternal depressive symptoms
Time frame: T2 (3 months post-baseline)
≥ 50% reduction in depressive symptoms on the 9-item Patient Health Questionnaire (PHQ-9) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. This variable will be dichotomized into 50% or greater reduction in depressive symptoms vs. less than 50% reduction in depressive symptoms from T1 to T2.
15 secondary outcomes
Clinically significant maternal depressive symptoms
Time frame: T2 (3 months post-baseline)
Child asthma exacerbations
Time frame: T3 (6 months post-baseline)
Child asthma symptoms
Time frame: T2 (3 months post-baseline), T3 (6 months post-baseline)
Maintenance
Time frame: T3 (6 months post-baseline)
Acceptability
Time frame: T2 (3 months post-baseline)
Maternal anxiety symptoms
Time frame: T2 (3-months post-baseline) and T3 (6months post-baseline)
Maternal PTSD symptoms
Time frame: T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child depressive symptoms
Time frame: T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child anxiety symptoms
Time frame: T2 (3 months post-baseline) and T3 (6 months post-baseline)
Child asthma control
Time frame: T2 (3 months post-baseline), T3 (6 months post-baseline)
Asthma management
Time frame: T2 (3 months post-baseline)
Reach
Time frame: T1 (Baseline)
Feasibility
Time frame: T2 (3 months post-baseline)
Satisfaction
Time frame: T3 (6 months post-baseline)
Staff-reported implementation outcomes
Time frame: At the end of year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual and aggregate survey data (including raw and recoded data) will be shared. The data from intervention sessions with Enhanced IPT-B participants will not be shared. Summarized aggregated deidentified data from the implementation-focused process evaluation will be made available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Margolis, PhD, MSW principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Brief Interpersonal Psychotherapy in people with Asthma in Children and Depression, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geraldine Mendez-Gonzalez ((202) 476-6956, GMENDEZGON@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal depressive symptoms (time frame: T2 (3 months post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.