Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression (TRACK to TREAT Phase 2)

Study Overview
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Brief Summary
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We will recruit 216 subjects meeting the eligibility criteria. After completing a baseline battery session via secure video conferencing and 3-week phone survey period, adolescents will be randomly assigned to receive 1 of 3 web-based single session interventions (SSIs) at a second secure video conference session. This second session for the intervention will take place within 2-3 weeks after the phone survey period. Immediately pre- and post-SSI, adolescents will complete a limited number of self-report questionnaires to index shifts in proximal outcomes. Participants, both adult and youth, will complete additional follow-up questionnaires 3, 6, 12, 18, and 24 months post-intervention. Participants will complete the intervention, including the pre- and post- SSI questionnaires, and follow-up surveys on their own.

Detailed Description
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216 eligible adolescents, along with one accompanying parent, will complete a Qualtrics baseline battery via a secure video-conference platform. This battery will be followed by a 3-week (ESM) period. In preparation for this 3-week period, adolescents with a personal smartphone will be assisted in downloading the ecological sampling method (ESM) app during the initial lab session. The participants will then receive an ESM tutorial, and a research team member will review each survey question with the adolescent to ensure comprehension. At the end of the initial session, participating families will schedule a second, brief meeting with the lab to help the adolescent set up the online intervention, which will be completed after the ESM period. During the ESM period following the baseline battery, adolescents will be prompted to complete the same 2-minute, 8-item survey 5 times per day for 21 days, via a smartphone-based, encrypted data collection app (LifeData). Notifications to complete surveys will occur every 2-3 hours. Responses will be deemed valid if completed within 2 hour of notification, ensuring at least 1-hour lags between surveys. Once the 3-week ESM period is complete, adolescents will be randomly assigned to receive 1 of 3 web-based single session interventions (SSIs) at a second secure video conference session. The second video conference session will be brief and is meant to help adolescents access the online intervention, which they will complete by themselves. This second session will take place within 2-3 weeks after the ESM period. Immediately pre- and post-SSI, adolescents will complete a limited number of self-report questionnaires by themselves to index shifts in proximal outcomes. The adolescent and parent pairs will, on their own, complete follow-up assessments at post-intervention. These assessments are abridged versions of the baseline battery. To enable longitudinal analysis of outcome trajectories, adolescents and parents will complete online follow-up questionnaires (including subjective reports of clinical and functional outcomes) 3, 6, 12, 18, and 24 months post-intervention. All follow-up surveys will be completed via Qualtrics, through personalized links sent to the family. All families will be debriefed by email, and the intervention SSI condition assignment will be revealed, after 24-month follow-up is complete. At this time, adolescents will be offered the opportunity to remotely complete the SSIs they did not originally receive.

Official Title
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Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression: Do Idiographic Symptom Structures Predict Response to Single Session Interventions?

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Supportive Therapy SSI
* Behavioral: Behavioral Activation SSI
* Behavioral: Growth Mindset SSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 11-16 (inclusive) at the time of study enrollment Has one parent or legal guardian willing to participate in the study Speaks English well enough to complete the smartphone-based questionnaire Comfort with smartphone-based surveys Indication of elevated risk for youth depression, one of two ways (or both ways): (a) elevations in depressive symptoms, at least 80th percentile or higher, based on parent-report CDI 2; (b) received treatment for depression within the previous 2 years Exclusion Criteria: Fail to meet the above-listed inclusion criteria Exit the study prior to condition randomization Respond with either copy/pasted responses from text earlier in the intervention to any of free response questions Obvious lack of English fluency in open response questions Responding with random text in open response questions Duplicate responses from the same individual in baseline or follow-up surveys Provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized (via a random number generator in Qualtrics, double-masking the randomization procedure) to one of the conditions.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supportive Therapy SSI (ST-SSI)<br>The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs. | Behavioral: Supportive Therapy SSI<br>* Online, 30-minute self-administered program for youth<br>* Other names: ST-SSI;|
| Experimental: Behavioral Activation SSI (BA-SSI)<br>The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles. | Behavioral: Behavioral Activation SSI<br>* Online, 30-minute self-administered program for youth<br>* Other names: BA-SSI;|
| Experimental: Growth Mindset SSI (GM-SSI)<br>Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used growth mindsets to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change. | Behavioral: Growth Mindset SSI<br>* Online, 30-minute self-administered program for youth<br>* Other names: GM-SSI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adolescent depressive symptom severity | The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth-reported depression severity, normed for youth age and sex and yielding raw and T scores. | Pre-intervention to 3-month follow-up; Pre-intervention to 6-month follow-up; Pre-intervention to 12-month follow-up; Pre-intervention to 18-month follow-up; Pre-intervention to 24-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parent-reported adolescent symptom severity | The Children's Depression Inventory (CDI) 2 - parent form will be used to note differences in youth depression severity. | Pre-intervention to 3-month follow-up; Pre-intervention to 6-month follow-up; Pre-intervention to 12-month follow-up; Pre-intervention to 18-month follow-up; Pre-intervention to 24-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Session Intervention, Online Intervention, Adolescent Depression, Mood Disorders, Experience Sampling Method