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

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.

SUBMITTER: Fedele DA

PROVIDER: S-EPMC10071332 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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

Fedele David A DA Thomas J Graham JG McQuaid Elizabeth L EL Gurka Matthew M Berg Cynthia A CA Prabhakaran Sreekala S

Contemporary clinical trials 20221115

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 adole ...[more]

PMID: 36396068

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Project description:BackgroundIn times of increasing mental health problems among young people, strengthening efforts to improve mental health through mental health promotion and prevention becomes increasingly important. Effective measures that support young people in coping with negative thoughts, feelings, and stress are essential, not just for the individual but also for society.ObjectiveThe aim of this paper is to provide a description of a cluster randomized controlled trial that will be conducted to examine the effectiveness of Opp, a universal mental health-promoting mobile app for adolescents aged 13 to 19 years that provides information and exercises to better cope with stress, negative thoughts, and negative feelings. The protocol was developed in accordance with the SPIRIT checklist.MethodsAn effectiveness study will be conducted with 3 measurement points: preintervention (T1), 2 weeks after the intervention (T2), and about 1 month after the intervention (T3). Adolescents will be recruited from middle and high schools in Norway and randomly assigned to the intervention or control groups. Randomization will be conducted on the school level. Opp can be downloaded from the Google Play or App Store but is password protected with a 4-digit code, which will be removed after study completion. Participants in the intervention group will receive a text message with the code to unlock the app. The participants in the intervention group can use Opp without limits on length or time of use. Objective data on how long or how often the participants use the app will not be collected. However, the second and third questionnaires for the intervention group contain app-specific questions on, for example, the use of the app.ResultsRecruitment and data collection started in August and September 2022. So far, 381 adolescents have answered the first questionnaire. Data collection was expected to end in December 2022 but has had to be prolonged to approximately June 2023. The results of the study will be available in 2023 at the earliest.ConclusionsThis project will contribute unique knowledge to the field, as there are few studies that have examined the effects of universal health-promoting mobile apps for adolescents. However, several limitations have to be taken into account when interpreting the results, such as randomization on the school level, the short time frame in which the study was conducted, and the lack of objective data to monitor the use of the app.Trial registrationClinicalTrials.gov NCT05211713; https://www.clinicaltrials.gov/ct2/show/NCT05211713.International registered report identifier (irrid)PRR1-10.2196/42119.

Project description:IntroductionAsthma is a leading cause of youth morbidity in the USA, affecting >8% of youth. Adherence to inhaled corticosteroids (ICS) can prevent asthma-related morbidity; however, the typical adolescent with asthma takes fewer than 50% of their prescribed doses. Adolescents are uniquely vulnerable to suboptimal asthma self-management due to still-developing executive functioning capabilities that may impede consistent self-regulation and weaken attempts to use problem solving to overcome barriers to ICS adherence.Methods and analysisThe aims of this project are to improve adherence to ICS as an important step towards better self-management among adolescents aged 13-17 years diagnosed with asthma by merging the efficacious behaviour change strategies found in behavioural health interventions with scalable, adaptive mobile health (mHealth) technologies to create the Responsive Asthma Care for Teens programme (ReACT). ReACT intervention content will be developed through an iterative user-centred design process that includes conducting (1) one-on-one interviews with 20 teens with asthma; (2) crowdsourced feedback from a nationally representative panel of 100 adolescents with asthma and (3) an advisory board of youth with asthma, a paediatric pulmonologist and a behavioural health expert. In tandem, we will work with an existing technology vendor to programme ReACT algorithms to allow for tailored intervention delivery. We will conduct usability testing of an alpha version of ReACT with a sample of 20 target users to assess acceptability and usability of our mHealth intervention. Participants will complete a 4-week run-in period to monitor their adherence with all ReACT features turned off. Subsequently, participants will complete a 4-week intervention period with all ReACT features activated. The study started in October 2018 and is scheduled to conclude in late 2019.Ethics and disseminationInstitutional review board approval was obtained at the University of Kansas and the University of Florida. We will submit study findings for presentation at national research conferences that are well attended by a mix of psychologists, allied health professionals and physicians. We will publish study findings in peer-reviewed journals read by members of the psychology, nursing and pulmonary communities.

Project description:Introduction: Previous studies have shown an improvement in the access to treatment for patients with first-episode psychosis (FEP), specifically young patients, through mobile app-based interventions. The aim of this study is to test the effectiveness of a mobile app-based intervention to improve community functioning in adolescents with FEP. Mobile app-based interventions could increase quality of life and disease awareness, which improve adherence to treatment and reduce the frequency of relapses and rehospitalizations in adolescents with FEP. Methods: This article describes a mobile app treatment and the pilot trial protocol for patients with FEP. We will perform a single-blind randomized clinical trial (RCT) including patients with FEP aged 14-19 years recruited from Gregorio Marañón Hospital, Madrid, Spain. Patients will be randomly assigned to an intervention group, which will receive treatment as usual plus five modules of a psychological intervention through the mobile app (psychoeducation, recognition of symptoms and prevention of relapses, problem solving, mindfulness, and contact wall), or to a control group (standard care). The effectiveness of the intervention will be assessed by means of an extensive battery of clinical tests at baseline and at 3 months of follow-up. The primary outcome is reduction in psychotic and depressive symptoms; secondary outcomes comprise adherence, awareness, use of drugs, and quality of life. Data will be analyzed on an intention-to-treat (ITT) basis. Mixed model repeated-measures analysis will be used to explore the following effect: group × time interaction between the control group and the intervention group for clinical and functional variables during the follow-up period. Discussion: This is an innovative study for the assessment of a psychological intervention through a mobile app for patients with FEP during the critical period. This pilot RCT is intended to be a precursor to larger studies, which in turn could facilitate dissemination of mobile app therapy for patients with FEP. Ethics and Dissemination: The local ethics committee approved the study protocol. All participants must sign the informed consent, to participate. After finalizing the study, the results will be published. Trial registration: NCT03161249. NCT clinicaltrials.gov. Date of registration in primary registry 02 May 2017. clinicaltrials.gov.

Project description:BackgroundOnline communities hold great potential as interventions for health, particularly for the management of chronic illness. The social support that online communities can provide has been associated with positive treatment outcomes, including medication adherence. There are few studies that have attempted to assess whether membership of an online community improves health outcomes using rigorous designs.ObjectiveOur objective was to conduct a rigorous proof-of-concept randomized controlled trial of an online community intervention for improving adherence to asthma medicine.MethodsThis 9-week intervention included a sample of asthmatic adults from the United Kingdom who were prescribed an inhaled corticosteroid preventer. Participants were recruited via email and randomized to either an "online community" or "no online community" (diary) condition. After each instance of preventer use, participants (N=216) were required to report the number of doses of medication taken in a short post. Those randomized to the online community condition (n=99) could read the posts of other community members, reply, and create their own posts. Participants randomized to the no online community condition (n=117) also posted their medication use, but could not read others' posts. The main outcome measures were self-reported medication adherence at baseline and follow-up (9 weeks postbaseline) and an objective measure of adherence to the intervention (visits to site).ResultsIn all, 103 participants completed the study (intervention: 37.8%, 39/99; control: 62.2%, 64/117). MANCOVA of self-reported adherence to asthma preventer medicine at follow-up was not significantly different between conditions in either intention-to-treat (P=.92) or per-protocol (P=.68) analysis. Site use was generally higher in the control compared to intervention conditions.ConclusionsJoining an online community did not improve adherence to preventer medication for asthma patients. Without the encouragement of greater community support or more components to sustain engagement over time, the current findings do not support the use of an online community to improve adherence.ClinicaltrialInternational Standard Randomized Controlled Trial Number (ISRCTN): 29399269; http://www.isrctn.com/ISRCTN29399269/29399269 (Archived by WebCite at http://www.webcitation.org/6fUbEuVoT).

Project description:BackgroundUnmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services.ObjectiveThis paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study's secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group.MethodsParticipants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children's hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria.ResultsRecruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants.ConclusionsEstablishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field's current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases.Trial registrationClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913.International registered report identifier (irrid)DERR1-10.2196/44940.

Project description:IntroductionAsthma is an incurable, lifelong condition that places children at increased risk for exacerbation, hospitalisation and school absences. Most paediatric asthma interventions target parents alone and are overly prescriptive. Improving Asthma Care Together (IMPACT) is a novel shared management system comprised of a mobile health (mHealth) application, symptom watch and tailored health intervention that pairs parent and child together as an asthma management team. IMPACT helps families monitor asthma status, tailor asthma management strategies and facilitate intentional transition of asthma management to the child. The purpose of this study is to determine the feasibility, acceptability and preliminary efficacy of the IMPACT intervention.Methods and analysisThis pilot randomised controlled trial will recruit 60 children with asthma (7-11 years) and one parent. All parent-child dyads will complete data collection sessions at baseline, postintervention and follow-up. Dyads randomised to the intervention group (IMPACT) will complete the 8-week intervention comprised of weekly activities including symptom monitoring, goal setting and progress monitoring. Dyads randomised to the control group will receive usual care but then be provided access to IMPACT at the end of the study. Feasibility will be measured by the proportion of eligible dyads enrolled and retained. Acceptability of IMPACT will be assessed using the Acceptability of Intervention Measure, the System Usability Scale and a semistructured interview. Preliminary efficacy is determined based on change in primary outcomes, parent-reported and child-reported asthma responsibility and asthma self-efficacy scores, from baseline.Ethics and disseminationThis study has been approved by the University of Washington Institutional Review Board; study ID: STUDY00010461. Participants gave informed consent to participate in the study before taking part. Study results will be disseminated in peer-reviewed journals and scientific conferences. A lay summary will be provided to study participants.Trial registration numberNCT04908384 (ClinicalTrials.gov identifier).

Project description:BackgroundAnxiety, mood, and substance use disorders have significant social and economic impacts, which are largely attributable to their early age of onset and chronic disabling course. Therefore, it is critical to intervene early to prevent chronic and debilitating trajectories.ObjectiveThis paper describes the study protocol of a CONSORT (Consolidated Standards of Reporting Trials)-compliant randomized controlled trial for evaluating the effectiveness of the Mind your Mate program, a mobile health (mHealth) peer intervention that aims to prevent mental health (focusing on anxiety and depression) and substance use problems in adolescents.MethodsParticipants will consist of approximately 840 year 9 or year 10 students (60 students per grade per school) from 14 New South Wales high schools in Sydney, Australia. Schools will be recruited from a random selection of independent and public schools across the New South Wales Greater Sydney Area by using publicly available contact details. The intervention will consist of 1 introductory classroom lesson and a downloadable mobile app that will be available for use for 12 months. Schools will be randomly allocated to receive either the mHealth peer intervention or a waitlist control (health education as usual). All students will be given web-based self-assessments at baseline and at 6- and 12-month follow-ups. The primary outcomes of the trial will be the self-reported use of alcohol and drugs, anxiety and depression symptoms, knowledge about mental health and substance use, motives for not drinking, and willingness to seek help. Secondary outcomes will include positive well-being, the quality of life, and the impact of the COVID-19 pandemic. Analyses will be conducted using mixed-effects linear regression analyses for normally distributed data and mixed-effects logistic regression analyses for categorical data.ResultsThe Mind your Mate study was funded by an Australian Rotary Health Bruce Edwards Postdoctoral Research Fellowship from 2019 to 2022. Some of the development costs for the Mind your Mate intervention came from a seed funding grant from the Brain and Mind Centre of the University of Sydney. The enrollment of schools began in July 2020; 12 of 14 schools were enrolled at the time of submission. Baseline assessments are currently underway, and the first results are expected to be submitted for publication in 2022.ConclusionsThe Mind your Mate study will generate vital new knowledge about the effectiveness of a peer support prevention strategy in real-world settings for the most common mental disorders in youth. If effective, this intervention will constitute a scalable, low-cost prevention strategy that has significant potential to reduce the impact of mental and substance use disorders.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12620000753954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379738&isReview=true.International registered report identifier (irrid)DERR1-10.2196/26796.

Dataset Information

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

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

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