Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623981
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
The Exhale Study Treating Maternal Depression in an Urban Pediatric Asthma Clinic
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 aged 4-11 years 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
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
Detailed Description:
The purpose of the study is to determine the effectiveness and implementation of Brief Enhanced Interpersonal Psychotherapy IPT-B an evidence-based treatment for maternal depression delivered in an urban pediatric asthma clinic This study is a pilot Hybrid Type 1 Effectiveness-Implementation single-blinded prospective randomized controlled trial A parallel two-group design will be used to evaluate the impact of the intervention Enhanced IPT-B among a sample of 48 Black mothers of children aged 4-11 years with asthma Mothers with clinically significant depressive symptoms PHQ-9 10 will be identified in the asthma clinic through routine depression screening during the childs visit and recruited to participate in the study if they meet eligibility criteria Following the informed consent process mothers randomized to the intervention group will receive Enhanced IPT-B Enhanced IPT-B consists of a single 45-60-minute pre-treatment engagement session followed by eight weekly 45-minute individual psychotherapy sessions carried out by a licensed mental health clinician within an 8-12-week timeframe Mothers randomized to the comparison group will receive Supplemented Usual Care which involves short-term care coordination to access community mental health resources Data on maternal mental health child asthma management and outcomes and child mental health will be collected from mothers and children at baseline 3 months post-baseline and 6 months post-baseline Data on implementation outcomes will be collected from mothers and asthma clinic leadership and staff Quantitative and qualitative data analysis strategies will be utilized to answer the research questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None