NCT06623981 The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
| NCT ID | NCT06623981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-15 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are: 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?
Eligibility Criteria
Inclusion Criteria: 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 * 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 Exclusion Criteria: 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) * 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
Contact & Investigator
Rachel Margolis, PhD, MSW
PRINCIPAL INVESTIGATOR
Children's National Research Institute
Frequently Asked Questions
Who can join the NCT06623981 clinical trial?
This trial is open to participants of all sexes, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06623981 currently recruiting?
Yes, NCT06623981 is actively recruiting participants. Contact the research team at GMENDEZGON@childrensnational.org for enrollment information.
Where is the NCT06623981 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06623981 clinical trial?
NCT06623981 is sponsored by Children's National Research Institute. The principal investigator is Rachel Margolis, PhD, MSW at Children's National Research Institute. The trial plans to enroll 60 participants.
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