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. Author manuscript; available in PMC: 2023 Apr 4.
Published in final edited form as: Contemp Clin Trials. 2022 Nov 15;123:107011. doi: 10.1016/j.cct.2022.107011

AIM2ACT: Randomized controlled trial protocol for a mobile health intervention for early adolescents with asthma

David A Fedele 1, J Graham Thomas 2, Elizabeth L McQuaid 2, Matthew Gurka 3, Cynthia A Berg 4, Sreekala Prabhakaran 3
PMCID: PMC10071332  NIHMSID: NIHMS1884740  PMID: 36396068

Abstract

Early adolescents diagnosed with asthma have difficulties consistently performing disease self-management behaviors, placing them at-risk for poor asthma control, morbidity, and reduced quality of life. Helpful caregiver support is pivotal in determining whether early adolescents develop and master asthma self-management behaviors. We developed Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT), a mobile health intervention to facilitate helpful caregiver support in early adolescents (12–15 year-olds) with poorly controlled asthma. AIM2ACT is a dyadic smartphone intervention that 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 skills training videos. This paper describes our plans to test the efficacy of AIM2ACT and evaluate 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 attention and novelty of a technology-based intervention for 6 months. Assessments will occur at baseline, post-intervention, and 3-, 6-, and 12-month follow-up time points. We will collect patient-reported and objectively monitored (e.g., spirometry, adherence) outcomes. Given the timing of the trial, a secondary exploratory goal is to evaluate the perceived impact of COVID-19 on family functioning and parental control of their adolescent’s asthma in the context of our intervention.

Keywords: asthma, mobile phone, mobile health, adolescent, self-management

Background

Adolescents with asthma suffer from impaired health and reduced quality of life due to complications that are largely preventable via self-management behaviors.1–4 The majority of adolescents with asthma have primary responsibility for disease management.5–12 Exceedingly low adherence to preventative medications,13–15 difficulty in monitoring and responding to symptoms, and challenges with trigger avoidance are widespread during this developmental period.16,17 As a result, adolescents have high rates of poor asthma control18 and are at significant risk for asthma-related morbidity, including severe exacerbations, urgent care visits, and missed days of school.2,19–22

Early adolescence, the developmental period where youth (ages 12–15) are beginning to assume primary responsibility for asthma self-management,23 is rife with difficulties. Early adolescents are at elevated risk for poor asthma control23 because they do not avoid triggers, monitor symptoms, and use preventative medication consistently.24,25 As early adolescents develop increasing independence, it is important to target asthma self-management behaviors; however, few self-management interventions exist that are designed for this unique developmental period.2,26

Helpful caregiver support is essential to determining whether adolescents develop and master asthma self-management behaviors, making caregiver support a key intervention target.27 Theoretical models of pediatric self-management28 and research with other chronic illnesses have identified specific behaviors, such as collaboration, parental monitoring, and warmth and acceptance, as vital to fostering self-management skills and health outcomes.29 Thus, we posit that caregivers can support their adolescent’s adherence to asthma self-management by continuing to monitor asthma care as their adolescent builds self-efficacy in disease management behaviors.

Mobile health (mHealth) is a highly feasible and acceptable intervention modality to facilitate helpful caregiver support as early adolescents with asthma develop and master self-management behaviors. mHealth is a highly prevalent and scalable intervention modality for early adolescents with asthma and their caregivers.30 mHealth has the potential to reach families with limited access to care since smartphone access is ubiquitous across racial/ethnic groups, geographic location, and socioeconomic strata.30 mHealth technologies can obtain near real-time data simultaneously from adolescents and caregivers, which can inform tailored interventions that are dynamic, user-centric, and continuously adapted.31,32 Moreover, the usability and acceptability of mHealth interventions are very high,33 with over 90% of individuals with asthma are willing to use smartphones for asthma education and self-management.34 mHealth is an optimal way for caregivers to remain involved in their adolescent’s care while providing a safe and structured environment for the development of asthma self-management behaviors. This environment has the potential to foster collaborative asthma management while avoiding emotional escalation and conflict that frequently occur during early adolescence.35,36

We developed AIM2ACT, a mHealth intervention delivered via smartphones, to facilitate helpful caregiver support as early adolescents with persistent asthma develop and master asthma self-management behaviors. AIM2ACT is informed by the Pediatric Self-Management Model28 and is specifically tailored for adolescent-caregiver dyads to increase helpful caregiver support and adolescent asthma self-efficacy, thereby improving asthma control.37 AIM2ACT uses ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors and a suite of engaging skills-training videos to help dyads better manage asthma. Results of our pilot trial show participants randomized to AIM2ACT had clinically significant improvements, supporting our scientific premise that facilitating helpful caregiver support among early adolescents can improve asthma outcomes.

The goal of our current study is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a large, fully-powered, randomized controlled trial to further support our scientific premise before pursuing clinical implementation. Our ongoing trial is responsive to calls for increased rigor in mHealth interventions by using a mHealth attention control comparator to assess the effectiveness of AIM2ACT in improving patient-reported and objective health outcomes up to 12 months post-intervention. This study began during the beginning of the COVID-19 pandemic. Thus, a secondary exploratory goal of the current study is to evaluate the perceived impact of COVID-19 on family functioning and parental control of their adolescent’s asthma in the context of our intervention.

Methods

Participants

Participants will include 160 adolescents between the ages of 12 and 15 years that have a persistent asthma diagnosis, poorly controlled asthma, and live in the same residence as their participating caregiver, who must be a legal guardian. We will exclude potentially eligible participants from the study for the following reasons: (1) they have a developmental disability that impairs their ability to complete study procedures; (2) they either cannot read or speak English; (3) they are currently enrolled in an asthma management intervention; or (4) a sibling is already enrolled in the study.

Recruitment

We will recruit via in-person efforts at UF Health pediatric pulmonary and general pediatric clinics as well as other pediatric asthma clinics in Florida that show interest in partnership. The UF Clinical and Translational Science Institute’s Recruitment Center will aid recruitment outside of the UF Health system by placing advertisements online (e.g., Researchmatch.org; Facebook), distributing brochures to local primary care clinics, and facilitating partnership with HealthStreet, a UF community engagement program. Finally, we will partner with TrialFacts, a company that aids recruitment for research studies via online ads, to provide referrals of potentially eligible participants.

Treatment Allocation

Interested families will be screened by research staff who will describe the study, determine initial eligibility, and schedule a baseline visit to obtain informed consent. We aim to randomize 160 dyads to obtain 120 families that complete all assessment time points. Prior to study commencement, our statistical methodologist will develop computer-generated random numbers for block randomization, which will ensure a 1:1 ratio of participants and stratification by adolescent sex. The research team and assessors will be masked to participant condition assignments.

AIM2ACT Components

Caregivers and adolescents each receive their own version of AIM2ACT on their respective smartphone. AIM2ACT uses an established mHealth platform from MEI Research, which allows investigators to develop fully customized intervention applications. AIM2ACT is a cloud-based mobile Android/iOS application that can deliver real-time surveys to participants as well as enable parents and adolescents to negotiate and set weekly asthma care goals.

Identification of Dyad-Specific Areas for Improvement in Asthma Self-Management.

The purpose of this component is to help dyads identify personalized areas of strength and weakness in asthma self-management behaviors, with the latter to be targeted for monitoring and improvement. The PROMIS Pediatric Asthma Impact Scale38 is administered to gauge asthma-related impairment. Ecological momentary assessment (EMA; brief surveys administered repeatedly via smartphone) captures asthma management behaviors from both adolescents and caregivers via prompts twice daily for one week and includes items from validated asthma management and impairment questionnaires.13,39–41

EMA also assesses adolescent and caregiver engagement and involvement in management tasks, as well as perceived barriers to completing asthma management behaviors. Frequency of rates of endorsed asthma management behaviors and dyadic agreement on the allocation of treatment responsibility are automatically synthesized from the adolescent and caregiver versions of AIM2ACT. The app completes this synthesis by using custom algorithms to estimate asthma-related impairment and determine a family’s asthma management strengths and areas for improvement. This personalized feedback is presented to families at the end of the one-week real-time assessment of needs period. Dyads complete additional EMA periods at the beginning of months 2 and 4 of the intervention period to receive updated personalized feedback and facilitate ongoing engagement in AIM2ACT.

Collaborative Asthma Management.

The purpose of this intervention component is to engage dyads in collaborative identification and tracking of asthma self-management goals that help early adolescents become increasingly independent in their care. As described below, the collaborative asthma management steps of goal setting, behavioral contracting, and problem-solving communication are completed by adolescents and caregivers through their respective versions of AIM2ACT.

Asthma Self-Management Goals.

AIM2ACT asks that adolescents select an asthma management goal from the personalized feedback provided after the one-week real-time assessment of needs period to facilitate motivation and self-efficacy towards developing and mastering self-management behaviors. AIM2ACT encourages adolescents to select goals that are specific, measurable, attainable, relevant, and time-bound (SMART). AIM2ACT provides several pre-populated SMART goals for dyads to select. Adolescents are also able to write an unlisted asthma management goal to accommodate individual preferences.

Behavioral Contracts for Asthma Self-Management Goals.

AIM2ACT guides dyads through a structured behavioral contracting process for the selected asthma management goal (see Figure 1). First, adolescents are asked to allocate responsibility for goal-related tasks, define the length of the goal period, and choose a reward for goal achievement. Next, the adolescent sends the plan to their caregiver, who reviews it in their version of AIM2ACT. To facilitate collaborative asthma management, AIM2ACT asks caregivers to either agree to the behavioral contract or return constructive feedback to their adolescent before beginning a plan. Skills training videos, which were informed by social cognitive theory,42 show caregivers how to reinforce their adolescent’s effort, problem-solve differences of opinion, and provide constructive feedback about the asthma care plan. Once dyads reach a behavioral contract, they can use AIM2ACT to monitor goal progress.

Figure 1.

Figure 1.

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Participant Flow through AIM2ACT

Problem-Solving Communication.

Problem-solving communication occurs at the end of each goal period, which can last up to 7 days. At this time, AIM2ACT asks the adolescent and caregiver to indicate whether the asthma management goal was accomplished, and encourages them to send each other positive, constructive feedback. Both adolescents and caregivers must verify discussion of feedback in AIM2ACT before beginning a new behavioral contract. If the goal was not achieved, AIM2ACT will suggest that families use collaborative problem-solving skills learned via AIM2ACT to arrive at a new asthma management goal.

Skills Training Videos.

This component provides dyads with skills training to understand how to use AIM2ACT and work together to set goals, develop and achieve the goals articulated in a behavioral contract, and engage in problem-solving communication. AIM2ACT includes a suite of animated skills training videos that guide dyads through all AIM2ACT components. AIM2ACT contains separate skills-training videos for adolescent and caregiver versions.

Self-guided asthma control

We use a mHealth attention control condition that accounts for staff attention and novelty of a technology-based asthma management intervention. Dyads in this condition complete a one-week real-time assessment of needs via EMA on their respective smartphones. However, dyads do not receive personalized asthma management feedback at the end of the one-week period. Additionally, dyads only receive static educational information on their smartphones about behavioral management techniques they can use to target improving asthma self-management. They are directed to use the static educational information to work towards improved asthma management over the remainder of the 6-month treatment period.

Procedure

Participants meeting eligibility criteria will complete an in-person baseline assessment visit to obtain informed consent and adolescent assent. We will inform families that they will be assigned to one of two app-based conditions. We will notify families of their assignment at Study Visit 1. Families will then complete study measures (see Table 1). Families will bring their adolescent’s current inhaled corticosteroid medication to each Study Visit so that study staff can attach an electronic adherence monitor (DOSER™) to the medication. We will monitor medication adherence for 30 days. Families will return electronic adherence monitors via prepaid postage to reduce the need for additional visits. Following Study Visit 1, the study staff will meet with families to orient them to the appropriate app and to setup the spirometer. Families can receive a total of $350 for participating in all study visits. Study visits can occur over Zoom, at a participant’s home, convenient community location, or UF (see Figure 2). In addition, adolescents may receive up to $30 per time-point (baseline, 2-months, 4-months, and 6-months) of the 6-month intervention (up to $120) that they complete 5 out of 7 at-home spirometry measurements. Finally, each parent and adolescent may receive $10 for completing both the morning and evening surveys for 5 out of 7 days during each 7-day EMA period.

Table 1.

AIM2ACT Outcome Measures

Outcome Measure Description
Demographics Self-reporta Child age/sex, caregiver marital status, educational level, family income, asthma medications, and child ED visits/hospitalizations
Asthma Severity and Morbidity Composite Asthma Severity Indexa,b A 5-item, validated instrument to assess recent daytime and nighttime asthma symptoms, lung function, current treatment regimen, and exacerbations. Indicators of asthma morbidity include missed school days, urgent care visits, emergency department visits, and hospitalizations
Asthma Control Asthma Control Testb Five-item validated scale used to measure asthma control
Pulmonary Function Portable spirometer - GoSpirob Forced expiratory volume in one second (FEV1), forced vital capacity, and forced expiratory flow 25–75%.
Asthma Medication Adherence Portable Medication Monitor - DOSER™b Electronic monitor of inhaled corticosteroids via the DOSER™ device
Child Asthma-related Quality of Life Paediatric Asthma Quality of Life Questionnaireb 13-item validated measure of adolescent’s asthma-related quality of life
Caregiver Involvement Adapted Parental Behavioral Involvement Scale 1-item measure to assess the frequency of caregiver involvement in asthma management
Caregiver Monitoring Adapted General Parental Monitoring scale Modified version of a 6-item monitoring scale used to assess caregiver involvement
Adolescent-caregiver asthma management conflict Family Environment Scalea,b Validated, 90-item measure to evaluate the social environment of the family unit
Asthma Management Self-Efficacy Asthma Management Efficacyb 14-item validated measure to assess adolescent asthma management self-efficacy
Impact of COVID-19 on Family Conflict and Cohesion COVID-19 Household Environment Scale (A-CHES)a,b 45-item measure to assess the impact of social distancing due to COVID-19 on household conflict and cohesion
Impact of COVID-19 on the Family COVID-19 Exposure and Family Impact Survey (CEFIS)a 38-item measure to assess both exposure to potentially traumatic aspects of COVID-19 and the impact of the pandemic on the family
Impact of COVID-19 on Parental Control of Child’s Asthma COVID Items for Parents surveya 16-item measure to assess parental control of adolescent’s asthma both before and after the COVID-19 pandemic
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a

Completed by caregiver

b

Completed by adolescent

Figure 2.

Figure 2.

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Study Visit Schedule

Study Outcomes

Demographics:

Demographic information collected will include the following: child sex, age, and race; caregiver age, sex, race, marital status, and educational level; family income.

Asthma Severity and Morbidity:

Asthma severity will be assessed via the Composite Asthma Severity Index.43,44 This 5-item instrument was validated by the Inner-City Asthma Consortium and is a composite of an adolescent’s recent daytime and nighttime asthma symptoms, lung function, current treatment regimen, and exacerbations. We will also collect indicators of asthma morbidity via caregiver-reported asthma-related missed school days, urgent care visits, emergency department visits, and hospitalizations.

Primary Outcome Measure:

Asthma Control will be assessed via the 5-item Asthma Control Test.45 The Asthma Control Test is a validated, adolescent-report questionnaire that measures asthma control in the past 4 weeks. This commonly used questionnaire is reliable, valid, responsive to change over time.46,47

Secondary Outcome Measures:

Pulmonary Function will be assessed via one week of at-home spirometry measurements requested at four intervention time points: Months 1, 2, 4, and 6. Measurements will include forced expiratory volume in one second (FEV1), forced vital capacity, and forced expiratory flow 25–75%. FEV1 percent predicted using Global Lung Function Initiative reference equations48 will be the pulmonary function outcome of interest. All spirometry measurements will be taken per American Thoracic Society guidelines49 after recommended calibrations using a GoSpiro (Monitored Therapeutics, Dublin, Ohio) portable, bluetooth-enabled spirometer. Dr. Prabhakaran (Co-I) will lead the training of study staff to complete spirometry using a standardized training protocol that we have used in previous trials.50,51 Our protocol includes hands-on spirometry training in the pediatric pulmonary clinic and review of practice efforts (e.g., flow-volume loop, acceptability standards) until the staff is deemed reliable. Families are provided a GoSpiro in advance of the onboarding study visit. Study staff conduct a manualized training with families on how to use the GoSpiro device and observe them complete successful measurements. Dr. Prabhakaran will monitor data quality. All data is remotely and automatically uploaded via Bluetooth to a secure researcher portal. Families are instructed to contact the study team for a device replacement if the GoSpiro is inoperable or is misplaced. Medication adherence will be assessed via electronic monitoring of inhaled corticosteroids using the DOSER™. The DOSER™ is a validated electronic adherence monitoring device that has been used in several studies.52,53 Consistent with our previous studies,14,54,55 objective adherence data will be monitored for 30 days and calculated as total doses taken per day divided by prescribed doses per day. Daily adherence will be truncated at 100%14 and the first three days of medication adherence data will be excluded to minimize effects due to novelty of the device. Data will be examined for device errors and differential patterns of adherence by medication and measurement type to inform analyses. Similar to the GoSpiro, families are instructed to contact the study team for a device replacement if the DOSER malfunctions or is misplaced. Asthma-related quality of life will be assessed via the 23-item adolescent-report Paediatric Asthma Quality of Life Questionnaire.56 This measure has strong psychometric properties and is sensitive to change.56,57

Mediators:

Caregiver involvement will be measured using a 1-item adolescent-report questionnaire that asks adolescents to indicate the frequency of caregiver involvement in asthma management.58 Caregiver monitoring will be assessed via adolescent-report using a modified version of a 6-item monitoring scale. This caregiver monitoring scale has strong psychometric properties and is sensitive to change over time.58–60 Adolescent-caregiver asthma management conflict will be assessed with the Family Environment Scale (FES).61 The Family Environment Scale is a validated, 90-item measure that evaluates the social environment of the family. For this project, we will use the Conflict, Expressiveness, and Cohesion subscales to measure the family environment. Asthma management self-efficacy for asthma self-management behaviors will be assessed via the adolescent-report Asthma Management Efficacy questionnaire.62 This measure is psychometrically sound and is frequently used in studies assessing adolescent asthma self-management outcomes.63

Impact of COVID-19.

The impact of COVID-19 on conflict and cohesion between adolescents and their parents will be measured by the COVID-19 Household Environment Scale (A-CHES).64 The impact of COVID-19 on the family will be measured by the COVID-19 Exposure and Family Impact Survey (CEFIS).65 Finally, the impact of COVID-19 on parental control of child’s asthma will be measured by the COVID Items for Parents survey. These questions were developed at the start of the pandemic by the investigator to determine the impact of the COVID-19 pandemic on parents’ ability to control their child’s asthma.

Moderators:

We will conduct exploratory analyses to better understand for whom and under what circumstances AIM2ACT is effective to inform the extent to which a tailored approach in future trials is needed. We will evaluate youth sex, age, and race/ethnicity as moderators due to potential developmental differences in our sample29,66 and known asthma-related health disparities across among racial/ethnic minorities.67

Intervention Engagement (Adherence):

Our mobile intervention platform automatically logs all aspects of participant engagement (e.g., date/time of use, content accessed). We will conduct exploratory analyses to examine frequency of engagement with AIM2ACT to identify components associated with improved outcomes. We will also assess trends in adolescent and caregiver usage over time to contextualize efficacy outcomes.

Power Analysis

Statistical power for the test of primary aims will be adequate if effect sizes are medium or larger (Cohen’s d ≥ .5). Based on our pilot work, we assume a SD = 5.5 for a 12-month change in ACT scores, in which case n = 160 (allowing for ≈ 20% dropout to provide us 120 participants with complete data) will provide 80% power to detect a difference of 2.84 or greater between the groups at 18 months. Given that it is generally recognized that a minimum clinically important difference for the ACT = 3,68 we will have adequate power to detect meaningful differences in our primary outcome. With respect to the mediation analysis of Aim 3, let X = Group assignment (binary, 50% allocation) and let M = our mediator of interest, with our focus on change in adolescent-caregiver asthma management conflict. From the pilot, the mean change was 0.69, while the SD = 2.18. The correlation between X and M = 0.185. Our mediation power analysis is based on the following regression equation:Y = β0 + βx(X) + βm + ey,, with SD(ey) = 5.16 from the pilot. With these estimates of variability and the correlation above, n = 120 with complete data would provide 80% power to detect a mediation effect of at least 0.62.69 The 95% CI for this parameter estimate from the pilot was (−0.54, 1.23), so the magnitude of this estimate is reasonable.

Statistical Analyses

Throughout the analysis, the statistical team will be blinded to group assignment. Ultimately, we are interested in modeling and comparing the trajectories of changes of our primary outcomes of Aims 1 and 2 relative to baseline across the study period. We will use a unified modeling approach across all aims of the study, considering the correlation of the repeated measures over time. We will use generalized linear mixed models across the outcomes for these two aims. Our primary test of interest is on the interaction of the fixed effects of group (AIM2ACT vs. mHealth attention control) and time. For valid inference on the fixed effects, we will use the Kenward-Roger denominator degrees of freedom. This modeling approach will allow us to compare trends over time, but also make inferences at given time points. We will include sex as a fixed effect given the stratified randomization. While we will explore numerous moderators (Exploratory Aims, described below), we will assess the moderating effect of adolescent sex via a statistical interaction (sex × group × time) to determine if the effect of AIM2ACT differed between males and females. For themeasures of intervention engagement listed above that are specific to the AIM2ACT intervention, we will examine correlations between these measures of engagement and our primary outcomes.

In evaluating the mediating effects of components of helpful caregiver support and adolescent self-efficacy on the total effect of AIM2ACT on our outcomes of interest, we will use a unified approach to mediation and interaction to decompose the total effect of AIM2ACT four ways:70,71 the effect due directly from AIM2ACT (controlled direct effect), the effect due to interaction only (reference interaction), the effect due to mediation only (pure indirect effect), and the effect due to mediation and interaction (mediated interaction). Such a decomposition will allow for a determination of the precise role our hypothesized mediators play in the effect of AIM2ACT on our primary outcomes. All measurements of adherence that are collected on both intervention groups will also be examined as mediators.

As mentioned above, we will examine the moderating effect of sex via statistical interactions in our primary models of Aims 1 and 2. We will also examine similar statistical interactions to provide preliminary data with respect to potential moderating effects of youth age and race/ethnicity that could be the focus of future studies of more tailored interventions. Finally, we will assess whether the potential moderating role of the impact of COVID-19 on functioning and parental control of their adolescent’s asthma.

Data Safety Monitoring

An independent Data Safety Monitoring Officer (DSMO) currently oversees participant safety, evaluates performance, monitors data quality, and provides advice regarding the status and continuation of AIM2ACT and its components. For all adverse events, an Adverse Event Record Form is completed that includes a description of the event, a classification of seriousness, an evaluation of potential relationship to the intervention, and an assessment of need for change in the informed consent or study activities.

Discussion

The AIM2ACT intervention uses a mHealth tool designed to help early adolescents diagnosed with persistent asthma develop and master asthma self-management skills. The goal of this study is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a large, fully-powered, randomized controlled trial to further support our scientific premise before pursuing clinical implementation. Given the timing of the trial, a secondary goal is to evaluate the perceived impact of COVID-19 on family functioning and parental control of their adolescent’s asthma in the context of our intervention.

mHealth interventions can be effective in improving disease self-management and health outcomes in pediatric samples;72 however, data on the effectiveness of mHealth interventions within asthma is mixed.73 Small sample sizes, poor study quality, and limited examination of long-term efficacy undermine rigor and generalizability of existing mHealth interventions for asthma,73 leading to calls for randomized controlled trials that evaluate the effectiveness of mHealth interventions in producing long-term changes in health.72 Our study is uniquely positioned to fill an important gap in the mHealth literature by determining whether AIM2ACT is efficacious and the extent to which it leads to sustained improvements in asthma control and other outcomes.

AIM2ACT is the first mHealth intervention that uses a dyadic approach to target adolescent asthma management. Our scientific premise is that helpful caregiver support is a key mechanism to improve asthma self-management in early adolescents with suboptimal asthma control. Building upon our pilot work, the current study will allow us to determine the extent to which components of helpful caregiver support (e.g., caregiver involvement) mediate the efficacy of AIM2ACT. Therefore, results from the current study will provide increased clarity regarding whether a mHealth intervention is an additional way to facilitate the transition of asthma management responsibilities from parent to adolescents during an important developmental period for asthma care.

Additionally, we posit that AIM2ACT, if efficacious, has high potential for scalability. AIM2ACT is delivered via smartphones, a ubiquitous technology that most adolescents and adults in the United States have access to regardless of income.30 Planned improvements to AIM2ACT will result in a fully automated mHealth intervention that does not require in-person clinic visits or the integration of additional sensors and associated subscription fees that could present as barriers to broad dissemination. Therefore, AIM2ACT may provide a mHealth framework that can be adapted and scaled to other pediatric chronic illnesses given the central role of helpful caregiver support in type 1 diabetes, cystic fibrosis, and numerous others.29,74

The expected outcome of this project is a mHealth intervention with high potential for scalability that addresses a critical need for an evidence-based intervention to facilitate helpful caregiver support as early adolescents develop and master asthma self-management behaviors. If efficacy of AIM2ACT is established, the next steps would involve exploring dissemination and implementation strategies.

Funding

This project is supported by funding from the National Institutes of Health (R01HL153119, PI: Fedele). The randomized controlled trial described in this paper is registered as NCT04448002.

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