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

NCT06875726 | Not Yet Recruiting

• 2 other identifiers: STUDY00019936R61MH132809
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Depression

  Baseline to 4 weeks

• Anxiety

  Baseline to 4 weeks

Other Outcomes (7)

• Step Count

  Baseline to 4 weeks

• Diagnostic Interview Schedule for Children

  Baseline to 4 weeks

• Activity Intensity

  Baseline to 4 weeks

Study Arms (1)

Treatment arm

EXPERIMENTAL

Behavioral: Sidekick

Interventions

Sidekick BEHAVIORAL

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

Treatment arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Officials

• Jessica Jenness, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren Szewczyk

CONTACT

2068801977; sidekick@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: Department of Psychiatry and Behavioral Sciences

Model Details: This is a single-arm study of a micro-randomized digital intervention for teens with depression. All teens will receive the intervention, and randomization of which time points a teen receives an intervention or not will occur within-subject. The intervention will consist of messages sent via a secure app. Intervention messages will be possible up to 2x/day with a 50% chance of being delivered at each time point.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share