Recruiting

Maternal Depression

Sponsor:

Children's National Research Institute

Code:

NCT06623981

Conditions

Asthma in Children

Depression

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Enhanced Brief Interpersonal Psychotherapy

Supplemented Usual Care

Study Details

Brief 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?

Conditions

Asthma in Children

Depression

Study ID

NCT06623981

Start date

Oct 15, 2024

Status verified date

Feb, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enhanced IPT-B

Enhanced Brief Interpersonal Psychotherapy

active comparator: Supplemented Usual Care

Short-term care coordination

Interventions

Enhanced 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.

Supplemented 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Geraldine Mendez-Gonzalez

(202) 476-6956GMENDEZGON@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Geraldine Mendez-Gonzalez

202-476-6956GMENDEZGON@childrensnational.org

Principal Investigator:

Rachel Margolis, PhD, MSW

More Information

Sponsor

Children's National Research Institute

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-02-24.