The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's National Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Primary caregiver of the child with asthma seen at the community-based asthma clinic
Female (self-identified)
Black (self-identified)
≥ 18 years of age
Disqualifiers
Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)
Bipolar disorder or mania
Schizophrenia
Current substance abuse/dependence
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Brief Interpersonal Psychotherapy
BehavioralEnhanced 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
BehavioralUsual 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Enhanced IPT-BExperimental treatment 1 intervention
Group B: Supplemented Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maternal depressive symptoms
≥ 50% reduction in depressive symptoms on the 9-item Patient Health Questionnaire (PHQ-9) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. This variable will be dichotomized into 50% or greater reduction in depressive symptoms vs. less than 50% reduction in depressive symptoms from T1 to T2.
Time frame
T2 (3 months post-baseline)Secondary outcomes
1
Clinically significant maternal depressive symptoms
9-item Patient Health Questionnaire (PHQ-9) score less than 10 (i.e., not clinically significant) at T2. The PHQ-9 score ranges from 0-27, with higher scores indicating more depressive symptoms. A score of 10 or more indicates clinically significant symptoms. This variable will be dichotomized into clinically significant and not clinically significant.
Time frame
T2 (3 months post-baseline)2
Child asthma exacerbations
Number of asthma exacerbations requiring steroids in the past 6 months
Time frame
T3 (6 months post-baseline)3
Child asthma symptoms
Mother-reported number of child asthma symptom-free days during the prior 14 days
Time frame
T2 (3 months post-baseline), T3 (6 months post-baseline)4
Maintenance
Percentage of enrolled mothers who remain in the study
Time frame
T3 (6 months post-baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's National Research Institute
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov