David A. Fedele, Ph.D. - US grants

? DESCRIPTION (provided by applicant): Pediatric asthma affects 9.6% of youth and is a leading cause of youth morbidity. Developing and mastering asthma self-management behaviors is imperative to control asthma and reduce morbidity among youth. Adolescents typically fail to perform the asthma self-management behaviors that prevent complications and enhance quality of life. Asthma self-management difficulties emerge in early adolescence as youth begin to transition towards taking more control of their treatment regimen, making it a critical intervention period. The presence or absence of helpful caregiver support often determines whether early adolescents ultimately develop and master asthma self-management behaviors. The aims of this application are to develop and test Team Speak, a mobile health (mHealth) tool, implemented via smartphones, that fosters helpful caregiver support as early adolescents with persistent asthma develop and master asthma self-management behaviors. To facilitate helpful caregiver support, Team Speak uses existing mHealth technology developed by the study team to elucidate tailored intervention targets for each family. Team Speak then facilitates collaborative caregiver/adolescent asthma management by automatically guiding dyads through a structured process that includes the supportive behavioral management strategies of goal setting, contingency management, and problem solving communication. Skills-training videos for adolescents and caregivers provide guidance on how to complete each collaborative asthma management component. We propose to develop Team Speak through iterative feedback from an advisory board composed of ten adolescent-caregiver dyads from the target user population and a pediatric pulmonologist. Following advisory board feedback, we will conduct a pilot randomized controlled trial of Team Speak with 50 early adolescents with poorly controlled asthma, ages 12-15 years, and a caregiver. Families will be randomly assigned to receive Team Speak or a self-guided control condition for a 4 month intervention period. Participants in the self-guided control condition will be given general information on supportive behavioral management techniques they can use to target improvement in asthma self-management behaviors. The control condition will serve as an attention control and is designed to optimize recruitment and sustain interest while concurrently having a minimal impact on asthma management. Feasibility, acceptability, and utilization data will be collected throughout the trial. Efficacy outcomes include changes in family asthma management (primary outcome), prescription refill history, lung function, asthma control, asthma-related quality of life, and sel-efficacy for asthma management. Data to evaluate efficacy outcomes will be collected at baseline, post-treatment, and 4 month follow-up time points. Feasibility, acceptability, and utilization of Team Speak will be determined by examining enrollment and attrition rates, usage statistics, and participant satisfaction with the Team Speak tool. If successful, this intervention offers excellent potential for wide spread dissemination to address a pressing public health problem.

PROJECT SUMMARY Asthma is the most prevalent childhood chronic illness, affecting 9.7% of adolescents. National guidelines emphasize the importance of adherence to self-management behaviors for controlling asthma and preventing impaired health and quality of life. Adolescents have suboptimal adherence to asthma self-management behaviors, placing them at risk for morbidity and reduced quality of life. Asthma self-management difficulties emerge in early adolescence as youth begin to transition towards taking more control of their treatment regimen, making it a critical intervention period. The presence of helpful caregiver support is pivotal in determining whether early adolescents ultimately develop and master asthma self-management behaviors. Our interdisciplinary team received NIH funding (PI: Fedele; R21 HD083830) to respond to the critical need for the development of an intervention to facilitate helpful caregiver support in early adolescents (12-15 year-olds) with poorly controlled asthma. AIM2ACT is a dyadic smartphone intervention, informed by the Pediatric Self- Management Model that is specifically tailored to increase helpful caregiver support and adolescent asthma self-efficacy, thereby improving asthma control. AIM2ACT contains three components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of engaging skills training videos to help dyads understand how to use AIM2ACT and work together to set asthma self-management goals, develop and achieve goals, and engage in problem-solving communication. Results of our pilot trial revealed high feasibility and acceptability of our protocol and preliminary efficacy for AIM2ACT in improving asthma control. The proposed study will test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a fully- powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver. Families will be randomly assigned to receive AIM2ACT (n=80) or a mHealth attention control condition (n=80) that accounts for staff attention and novelty of a technology-based intervention for 6 months. Dyads in the control condition will not receive personalized asthma management feedback, will not be guided through collaborative identification and tracking of asthma self-management goals, and will not have access to skills training videos. Instead, they will receive static educational information on their smartphones about behavioral management techniques they can use to target improving asthma self- management. The control condition is designed to optimize recruitment and sustain interest while concurrently having a minimal impact on asthma management. Assessments will occur at baseline, post-intervention, and 3-, 6-, and 12-month follow-up time points. Patient-reported (e.g., Asthma Control Test) and objectively monitored (e.g., spirometry, medication adherence) outcomes will be collected.