Treating maternal depression in mothers of children with asthma
Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic
This study is testing a new therapy for mothers with depression who have children with asthma to see if it helps improve their mental health and their child's asthma management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06623981 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Enhanced Brief Interpersonal Psychotherapy (IPT-B) for mothers experiencing depression, specifically those with children aged 4-11 years who have asthma. Conducted in an urban pediatric asthma clinic, the study will compare the outcomes of mothers receiving Enhanced IPT-B to those receiving supplemented usual care. The trial will assess changes in maternal depressive symptoms, child asthma management, and overall health outcomes over a period of six months. Participants will be recruited through routine depression screenings during their child's clinic visits.
Who should consider this trial
Good fit: Ideal candidates are Black mothers aged 18 and older with clinically significant depressive symptoms whose children are aged 4-11 years and have physician-diagnosed persistent asthma.
Not a fit: Patients who are acutely suicidal, have bipolar disorder, schizophrenia, or significant medical co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve mental health outcomes for mothers and enhance asthma management for their children.
How similar studies have performed: Other studies have shown promise in addressing maternal mental health and its impact on child health outcomes, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Margolis, PhD, MSW — Children's National Research Institute
- Study coordinator: Geraldine Mendez-Gonzalez
- Email: GMENDEZGON@childrensnational.org
- Phone: (202) 476-6956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.