Implementation of a Just-In-Time Adaptive Intervention for Adolescent Anxiety

NCT06946823 | Not Yet Recruiting

• 1 other identifier: STUDY00033184
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Anxiety; Anxiety Disorders; Anxiety Disorder of Childhood

Keywords

Anxiety; Just-In-Time Adaptive Intervention; Smartphone; Behavioral Health; Community-Engaged Research; Adolescents; Rural; Digital Intervention; Participatory Design; Somatic

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 3 months

• 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.

  Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)

• 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.

  Baseline and 3 months

• 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.

  Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)

Secondary Outcomes (5)

• Pragmatic and Hedonic User Experience

  3 months after baseline

• Technology Engagement

  3 months after baseline

• User Engagement

  3 months after baseline

• Percentage of app-based intervention activities completed by participants

  Baseline through 3-month treatment period

• Number of participants who complete the study

  End of treatment period (3 months after baseline)

Study Arms (2)

Just-In-Time Adaptive Intervention for Adolescent Anxiety

EXPERIMENTAL

Participants in the Just-In-Time Adaptive Intervention for Adolescent Anxiety Arm will receive the just-in-time adaptive smartphone tool and be instructed to respond to the tool's prompts and follow delivered behavioral recommendations throughout the 3-month intervention period.

Device: Just-In-Time Adaptive Intervention for Adolescent Anxiety

Waitlist Control

NO INTERVENTION

Participants in the Waitlist Control Arm will receive the just-in-time adaptive smartphone tool following the completion of the 3-month intervention period.

Interventions

Just-In-Time Adaptive Intervention for Adolescent Anxiety DEVICE

A JITAI smartphone app to reduce anxiety levels among rural adolescents by delivering somatic-based activity recommendations

Just-In-Time Adaptive Intervention for Adolescent Anxiety

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescent (age 13-17 years old)
• New Hampshire resident
• Fluency in English
• Able to provide assent
• At least mild (≥5) anxiety based on the GAD-7 assessment

You may not qualify if:

• Under 13 years old
• Over 17 years old
• Not a New Hampshire resident
• Unable to provide assent
• Less than mild (\<5) anxiety based on the GAD-7 assessment

Sponsors & Collaborators

• Trustees of Dartmouth College: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Elizabeth Murnane, PhD

CONTACT

603-646-0775; emurnane@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Engineering

Model Details: 50 rural adolescents experiencing elevated anxiety levels will be randomly assigned to the JITAI tool for a treatment period of 3 months or a waitlist control.

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 27, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share