Clinical trial NCT04607902: Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression (TRACK to TREAT Phase 2)
Official title: Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression: Do Idiographic Symptom Structures Predict Response to Single Session Interventions?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Single Session Intervention
Online Intervention
Adolescent Depression
Mood Disorders
Experience Sampling Method
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 216
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized (via a random number generator in Qualtrics, double-masking the randomization procedure) to one of the conditions.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in adolescent depressive symptom severity
timeFrame: 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 outcomes:
measure: Changes in parent-reported adolescent symptom severity
timeFrame: 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
Other outcomes:
measure: Demographics
timeFrame: Pre-intervention only (sex, race); Pre-intervention, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up (age, gender identity, mental health treatment history)
measure: Pubertal development
timeFrame: Pre-intervention only
measure: Adverse Childhood Experiences (ACEs) for parent and child
timeFrame: Pre-intervention only
measure: Self-Hate and related constructs
timeFrame: 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
measure: Inventory of Depression and Anxiety Symptoms (IDAS-II)
timeFrame: 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
measure: Screen for Child Anxiety and Related Disorders (SCARED)
timeFrame: 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
measure: Behavioral Activation for Depression Scale (BADS)-Short Form
timeFrame: 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
measure: Self-Referential Encoding Task (SRET)
timeFrame: Pre-intervention
measure: The Dietary Restriction Screener (DRS)
timeFrame: 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
measure: Self-Injurious Thoughts and Behaviors Interview-Short Form (SITBI-SF)
timeFrame: 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
measure: Secondary Control Scale for Children (SCSC)
timeFrame: 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
measure: Hopelessness
timeFrame: Immediately Pre- to Immediately Post-intervention; 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
measure: Perceived agency
timeFrame: 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
measure: Implicit Personality Theory Questionnaire (IPTQ)
timeFrame: Immediately Pre- to Immediately Post-intervention; 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
measure: Brief Family Assessment Measure (General Scale)
timeFrame: 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
measure: Multidimensional Peer Victimization Scale
timeFrame: 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
measure: UCLA Loneliness Scale
timeFrame: 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
measure: Brief Symptom Inventory-18
timeFrame: 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
measure: Perceived barriers to treatment
timeFrame: Pre-SSI only
measure: Prognostic Pessimism For Depression
timeFrame: 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
measure: COVID-19 Items
timeFrame: Pre-intervention only
measure: Ecological Sampling Method Surveys (ESM)
timeFrame: Pre-intervention only
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Jessica L Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References: