RECRUITING

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

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Conditions

Asthma in ChildrenDepression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

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

Quick Facts

Study Start:2024-10-15
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06623981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary caregiver of the child with asthma seen at the community-based asthma clinic
  2. * Female (self-identified)
  3. * Black (self-identified)
  4. * ≥ 18 years of age
  5. * English-speaking
  6. * PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit
  7. * Younger than 17 years and 7 months at the date of enrollment
  8. * Publicly insured
  9. * Physician-diagnosed persistent asthma
  1. * Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)
  2. * Bipolar disorder or mania
  3. * Schizophrenia
  4. * Current substance abuse/dependence
  5. * Current serious physical intimate partner violence (IPV)
  6. * Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease)
  7. * Enrolled in another intervention with a behavioral component and/or novel asthma therapeutics

Contacts and Locations

Study Contact

Geraldine Mendez-Gonzalez
CONTACT
(202) 476-6956
GMENDEZGON@childrensnational.org

Principal Investigator

Rachel Margolis, PhD, MSW
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

Children's National Hospital
Washington D.C., District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Rachel Margolis, PhD, MSW, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma in Children
  • Depression