Clinical trial NCT04634903: Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19
Official title: Comparing Two Online Single-Session Interventions for Adolescent Depression: Outcomes of a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: single-session interventions
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: University of Denver
First posted: 2020-11-18
Enrollment: 2452
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the Behavioral Activation SSI (BA-SSI), Growth Mindset SSI (GM-SSI), or the Supportive Therapy SSI (ST-SSI; each 30 minutes in length).
Primary purpose: TREATMENT

Brief summary: Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* are fluent in English
* have consistent internet and computer/laptop/smartphone access
* report elevated depressive symptoms (a score of \>2 on the Patient Health Questionnaire-2 item version \[PHQ-2\])

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

We will also exclude for primary analyses (but may run sensitivity analyses including them) any participants who 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-SSI to 3-month follow-up
Secondary outcomes:
measure: Change in State Hope Scale - Pathways Subscale
timeFrame: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up
measure: Change in Beck Hopelessness Scale - 4 Item Version
timeFrame: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up
measure: Program Feedback Scale
timeFrame: Immediately Post-SSI only
Other outcomes:
measure: Change in Behavioral Activation for Depression Scale - Short Form
timeFrame: Pre-SSI to 3-month follow-up
measure: Change in Self-Injurious Thoughts and Behaviors Interview-Short Form (SITBI-SF)
timeFrame: Pre-SSI to 3-month follow-up
measure: Change in Implicit Personality Theory Questionnaire
timeFrame: Pre-SSI, Immediately Post-SSI
measure: Demographic Questions
timeFrame: Pre-SSI only
measure: Perceived Socioeconomic and Social Status
timeFrame: Pre-SSI only
measure: Multidimensional Peer Victimization Scale
timeFrame: Pre-SSI only
measure: UCLA Loneliness Scale
timeFrame: Pre-SSI only
measure: Self-Referential Encoding Task (SRET)
timeFrame: Pre-SSI
measure: Discrimination
timeFrame: Pre-SSI
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Pre-SSI
measure: COVID-19-related Stressors
timeFrame: Pre-SSI only
measure: Change in COVID-19-related Trauma Symptoms
timeFrame: Pre-SSI to 3-month follow-up
measure: Disordered Eating
timeFrame: Pre-SSI to 3-month follow-up
measure: Adverse Childhood Experiences (ACEs) Scale
timeFrame: Pre-SSI only
measure: Brief Screener for Tobacco, Alcohol, and Other Drugs (BSTAD)
timeFrame: Pre-SSI only
measure: Perceived Pre-to-post SSI Change Items
timeFrame: Immediately Post-SSI 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:
citation: Cohen KA, Shroff A, Nook EC, Schleider JL. Linguistic distancing predicts response to a digital single-session intervention for adolescent depression. Behav Res Ther. 2022 Dec;159:104220. doi: 10.1016/j.brat.2022.104220. Epub 2022 Oct 20.
citation: Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.