Implementation of a Just-In-Time Adaptive Intervention for Adolescent Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorTrustees of Dartmouth College
About this trial
The goal of this clinical trial is to evaluate a smartphone based just-in-time adaptive intervention (JITAI) tool to deliver somatic behavioral recommendations for anxiety management among youth. The main questions it aims to answer are:
* Is the JITAI tool acceptable among the adolescent study population? * Is the JITAI tool feasible to deliver to the adolescent study population? * Does the study support preliminary efficacy of the JITAI tool among the adolescent study population?
The tool will be pilot-tested among a sample of 50 rural adolescents experiencing elevated anxiety levels who will be randomly assigned to the JITAI tool or a waitlist control, for a treatment period of 3 months.
Participants will be asked to:
* Use the smartphone based JITAI tool which will deliver somatic behavioral recommendations intended to manage anxiety levels for a treatment period of 3 months * Respond to the tool's prompts on a daily basis and follow the delivered behavioral recommendations * Complete anxiety and interoception assessments at study start, study end (3 months), and one-month follow-up * Complete usability and user experience instruments at study end (3 months)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescent (age 13-17 years old)
New Hampshire resident
Fluency in English
Able to provide assent
Disqualifiers
Under 13 years old
Over 17 years old
Not a New Hampshire resident
Unable to provide assent
Trial design
Design model
Sequential
Treatments tested in this trial
Just-In-Time Adaptive Intervention for Adolescent Anxiety
DeviceA JITAI smartphone app to reduce anxiety levels among rural adolescents by delivering somatic-based activity recommendations
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Just-In-Time Adaptive Intervention for Adolescent AnxietyExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline in Symptoms of Generalized Anxiety at 3 Months
Units on a scale measured through the GAD-7 (Generalized Anxiety Disorder-7) self-report questionnaire. Minimum score = 0, maximum score = 21, with a higher score indicating worse anxiety symptoms.
Time frame
Baseline and 3 months2
Change from Post-Treatment Symptoms of Generalized Anxiety to 1-month follow-up
Units on a scale measured through the GAD-7 (Generalized Anxiety Disorder-7) self-report questionnaire. Minimum score = 0, maximum score = 21, with a higher score indicating worse anxiety symptoms.
Time frame
Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)3
Change from Baseline in Interoceptive Awareness at 3 Months
Units on a scale measured through the MAIA-Y (Multidimensional Assessment of Interoceptive Awareness for Youth) self-report questionnaire. Minimum score = 1, maximum score = 5, with higher scores indicating greater interoceptive awareness.
Time frame
Baseline and 3 months4
Change from Post-Treatment Interoceptive Awareness to 1-month follow-up
Units on a scale measured through the MAIA-Y (Multidimensional Assessment of Interoceptive Awareness for Youth) self-report questionnaire. Minimum score = 1, maximum score = 5, with higher scores indicating greater interoceptive awareness.
Time frame
Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)Secondary outcomes
1
Pragmatic and Hedonic User Experience
The AttrakDiff instrument assesses 4 dimensions of user experience (usability, stimulation, identity, and attractiveness) using a 7-point semantic differential scale where respondents choose between bipolar adjective pairs to produce an overall mean score. Minimum score = -3, maximum score = +3, where higher scores indicate a more usable and appealing tool.
Time frame
3 months after baseline2
Technology Engagement
The GiggleGauge instrument assesses user engagement through a self-report questionnaire with a binary ordinal scale. Minimum score = 5, maximum score = 10, where higher scores indicate a more engaging tool.
Time frame
3 months after baseline3
User Engagement
The User Engagement Scale (UES) instrument assesses user engagement with digital interventions through a self-report questionnaire on a 5-point Likert scale. Minimum score = 1, maximum score = 5, where higher scores indicate a more engaging tool.
Time frame
3 months after baseline4
Percentage of app-based intervention activities completed by participants
Compliance will be assessed by calculating the percentage of assigned app-based intervention activities completed by each participant over the 3-month treatment period. Completion data will be automatically recorded by the app.
Time frame
Baseline through 3-month treatment periodLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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