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NCT Number: NCT06875726

Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care

The goal of this clinical trial is to learn if a tailored smartphone intervention called Sidekick can help improve sleep and physical activity for teenagers in depression treatment. The main question it aims to answer is:

Does Sidekick help teens improve sleep or physical activity?

Teen participants will be asked to complete surveys about how they are feeling and doing at the beginning of the study and throughout their participation. All teen participants will be able to use the Sidekick app during the study.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking
  • 13 to 17 years old
  • PHQ-8 score ≥5
  • PHQ-8 rating of ≥1 on anhedonia, sleep, or fatigue items
  • Own a personal smartphone

Exclusion criteria

  • Active safety concerns (e.g., acute suicidal ideation)
  • Diagnosed developmental disability (e.g., autism spectrum)
  • Primary mental health diagnosis other than MDD according to baseline Mini-international Neuropsychiatric Interview (MINI) (comorbidity allowed when MDD primary)
  • Sleep disorder from another medical cause
  • Inability to engage in moderate exercise because of medical concerns;

Treatment and study plan

Sidekick

Behavioral

Sidekick is a just-in-time adaptive intervention that sends behavior change messages based on personalized sleep and physical activity goals.

Primary outcomes

  1. Sleep disturbance

    Time frame: Baseline to 4 weeks

    The PROMIS Sleep Disturbance 8a scale for adolescents is a self-report assessment of sleep difficulties over the past week. It includes 8 items related to sleep quality and disturbances rated on a 5-point scale. Raw scores (range: 8 - 40) are converted to normalized T-scores, with higher scores indicating greater sleep disturbance

  2. Sleep related impairment

    Time frame: Baseline to 4 weeks

    The PROMIS Sleep-Related Impairment measure is a self-report assessment of the impact of sleep disturbances on daily functioning over the past week. It includes 8 items related to how sleep problems affect activities like school performance, mood, and social interactions, rated on a 5-point scale. Raw scores (range: 8-40) are converted to normalized T-scores, with higher scores indicating greater impairment in daily functioning due to sleep issues.

  3. Sleep Quality

    Time frame: Baseline to 4 weeks

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report assessment of sleep quality over the past month. It includes 19 items covering sleep patterns, duration, disturbances, and daytime dysfunction. Response values are combined into components produce a global score (range: 0-21), with higher scores indicating poorer sleep quality and greater sleep-related difficulties.

  4. Physical Activity Questionnaire - Adolescent

    Time frame: Baseline to 4 weeks

    The Physical Activity Questionnaire for Adolescents (PAQ-A) is a self-report assessment of physical activity levels in adolescents over the past 7 days. It includes 9 items related to the frequency and intensity of various physical activities, with responses on a 5-point scale. Scores are summed and averaged, with higher scores indicating greater physical activity levels.

Secondary outcomes

  1. Depression

    Time frame: Baseline to 4 weeks

    The Patient Health Questionnaire-9 (PHQ-9) is a self-report tool used to assess the severity of depressive symptoms over the past two weeks. It includes 9 items related to mood, interest, and other depressive symptoms, rated on a 4-point scale. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms and greater impairment.

  2. Anxiety

    Time frame: Baseline to 4 weeks

    The Generalized Anxiety Disorder-7 (GAD-7) is a self-report assessment of the severity of anxiety symptoms over the past two weeks. It includes 7 items related to anxiety-related feelings like worry, restlessness, and physical symptoms, rated on a 4-point scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms and greater impairment.

Other outcomes

  1. Step Count

    Time frame: Baseline to 4 weeks

    Step count will be collected via the Garmin smartwatch. The average daily step count over the 2-week baseline data collection period will be compared to the average daily step count in the last week of the intervention.

  2. Diagnostic Interview Schedule for Children

    Time frame: Baseline to 4 weeks

  3. Activity Intensity

    Time frame: Baseline to 4 weeks

    Activity intensity will be collected via the Garmin smartwatch, categorized into light, medium, and vigorous. The average daily minutes of moderate + vigorous activity during the 2-week baseline data collection period will be compared to the average daily minutes of moderate + vigorous activity in the last week of the intervention.

  4. Suicide Ideation

    Time frame: Baseline to 4 weeks

    The Suicide Ideation Questionnaire-Junior (SIQ-Jr) measures the frequency of suicide ideations in the past month. The 15-item self-report assessment records frequency on a 7 point scale ranging from "Almost every day" (0) to "I never had this thought" (7). Scores range from 0 to 90 with higher scores indicating greater frequency of SI.

  5. Functional Impairment

    Time frame: Baseline to 4 weeks

    The Weiss Functional Impairment Rating Scale (WFIRS) is a self-report tool used to assess the functional impairment associated with ADHD symptoms across various domains, such as family, social, school/work, and emotional functioning. It includes 18 items rated on a 5-point scale. Total scores indicate the level of impairment, with higher scores reflecting greater functional difficulties and more significant impact on daily life.

  6. Sleep Duration

    Time frame: Baseline to 4 weeks

    Sleep duration will be collected via the Garmin smartwatch. The average daily sleep duration (in minutes) during the 2-week baseline data collection period will be compared to the average daily sleep duration (in minutes) in the last week of the intervention.

  7. Midpoint sleep variability

    Time frame: Baseline to 4 weeks

    The midpoint of sleep (clock time halfway between bedtime and waketime) will be collected via the Garmin smartwatch. The standard deviation of the midpoint during the two week baseline period will compared to the standard deviation of the midpoint during the last two weeks of the intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Warren Szewczyk

CONTACT

[email protected]

2068801977

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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