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
Children's National Research Institute
60 participants
Oct 15, 2024
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
Inclusion Criteria11
- 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 Criteria10
- 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
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06623981