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

Sponsor
Trustees of Dartmouth College
Study ID
NCT06946823
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Anxiety Disorder of Childhood
  • Anxiety Disorders

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

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

Study Details

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)

Key Dates

First listed
Apr 27, 2025
Start date
Jan 31, 2027
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Just-In-Time Adaptive Intervention for Adolescent Anxiety
    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.
  • No Intervention: Waitlist Control
    Participants in the Waitlist Control Arm will receive the just-in-time adaptive smartphone tool following the completion of the 3-month intervention period.

Primary Outcome Measure

Change from Baseline in Symptoms of Generalized Anxiety at 3 Months [ Time Frame: Baseline and 3 months ]

Central Contacts

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