The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
NCT ID: NCT06623981
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-15
2027-04-30
Brief Summary
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1. Does Enhanced IPT-B decrease maternal depressive symptoms?
2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)?
3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced IPT-B
Enhanced Brief Interpersonal Psychotherapy
Enhanced Brief Interpersonal Psychotherapy
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 Care
Short-term care coordination
Supplemented Usual Care
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.
Interventions
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Enhanced Brief Interpersonal Psychotherapy
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 Care
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit
Child:
* Younger than 17 years and 7 months at the date of enrollment
* Publicly insured
* Physician-diagnosed persistent asthma
Exclusion Criteria
* 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)
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
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Children's National Research Institute
OTHER
Responsible Party
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Principal Investigators
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Rachel Margolis, PhD, MSW
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00001112
Identifier Type: -
Identifier Source: org_study_id