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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT06623981
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Brief Interpersonal Psychotherapy — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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?

Key Dates

Start date
Oct 15, 2024
Status verified
Feb 2026
Primary completion
Dec 15, 2026
Completion
Mar 15, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enhanced IPT-B
    Enhanced Brief Interpersonal Psychotherapy
  • Active Comparator: Supplemented Usual Care
    Short-term care coordination

Primary Outcome Measure

Maternal depressive symptoms [ Time Frame: T2 (3 months post-baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Geraldine Mendez-Gonzalez
[email protected]
202-476-6956
Rachel Margolis, PhD, MSW (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Children's National Hospital· Washington D.C., DC

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