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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Sidekick

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Warren Szewczyk; Phone Number: 2068801977; Email: sidekick@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. English-speaking
2. 13 to 17 years old
3. PHQ-8 score ≥5
4. PHQ-8 rating of ≥1 on anhedonia, sleep, or fatigue items
5. Own a personal smartphone

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm	Behavioral: Sidekick; Sidekick is a just-in-time adaptive intervention that sends behavior change messages based on personalized sleep and physical activity goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep disturbance	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	Baseline to 4 weeks
Sleep related impairment	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.	Baseline to 4 weeks
Sleep Quality	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.	Baseline to 4 weeks
Physical Activity Questionnaire - Adolescent	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.	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	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.	Baseline to 4 weeks
Anxiety	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.	Baseline to 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Count	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.	Baseline to 4 weeks
Diagnostic Interview Schedule for Children		Baseline to 4 weeks
Activity Intensity	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.	Baseline to 4 weeks
Suicide Ideation	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.	Baseline to 4 weeks
Functional Impairment	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.	Baseline to 4 weeks
Sleep Duration	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.	Baseline to 4 weeks
Midpoint sleep variability	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.	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jessica Jenness, Ph.D., University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: STUDY00019936; R61MH132809 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No