Clinical Trials Directory

Trials / Completed

CompletedNCT02206061

School-based Asthma Care for Teens (SB-ACT)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
430 (actual)
Sponsor
University of Rochester · Academic / Other
Sex
All
Age
12 Years – 16 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to evaluate the widespread implementation of a developmentally appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed therapy (DOT) to allow the teen to experience the potential benefits from adhering to guideline-based asthma treatment, and 2) a developmentally appropriate Motivational Interviewing (MI) Counseling Intervention to help the teen transition to independent long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT program will 1) experience less asthma-related morbidity than an asthma education (AE) attention-control comparison group, and 2) have improved adherence, less urgent healthcare use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The investigators also hypothesize that participants receiving DOT-only will have improved asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but will not have sustained, clinically significant improvement in outcomes once the DOT phase is complete. This represents a unique opportunity to build upon existing community relationships with an innovative and developmentally focused program to improve asthma outcomes for urban teens.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSchool-Based Asthma Care for Teens (SB-ACT)
BEHAVIORALDirectly Observed Therapy
BEHAVIORALAsthma Education

Timeline

Start date
2014-07-01
Primary completion
2020-03-01
Completion
2021-02-01
First posted
2014-08-01
Last updated
2021-05-14
Results posted
2021-02-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02206061. Inclusion in this directory is not an endorsement.