RecruitingNot ApplicableNCT06623981

The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic

Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic


Sponsor

Children's National Research Institute

Enrollment

60 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study — called the Exhale Study — tests a depression treatment program for Black mothers whose children are being treated for asthma in an urban pediatric clinic. Researchers believe that treating a mother's depression can also improve her child's asthma outcomes by reducing stress in the home environment. **You may be eligible if...** - You are a Black woman aged 18 or older who is the primary caregiver of a child with asthma at the study clinic - You speak English - You screened positive for depression symptoms (PHQ-9 score of 8 or higher) - Your child is under 18 for the full 6-month study and has publicly-funded insurance and a physician diagnosis of persistent asthma **You may NOT be eligible if...** - You are at high risk of suicide - You have bipolar disorder, mania, or schizophrenia - You have a current substance use disorder - You are experiencing serious physical domestic violence - You lack the capacity to give meaningful consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEnhanced 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.

BEHAVIORALSupplemented 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.


Locations(1)

Children's National Hospital

Washington D.C., District of Columbia, United States

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NCT06623981


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