Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19

Stony Brook University2,452 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,452

Conditions

Depression

Interventions

Eligibility

Sex: ALLMin age: 13 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Adolescent Depressive Symptom Severity

The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw scores ranging from 0-24, where higher scores indicate more severe symptoms of depression.

Time frame: Pre-SSI to 3-month follow-up

Secondary Outcomes

Change in State Hope Scale - Pathways Subscale

The State Hope Scale - Pathways Subscale asks participants to rate 3 statements based on how they think about themselves right now. Participants rate the 3 statements on an 8 point scale ranging from 0 (Definitely False) to 7 (Definitely True). Total score ranges, reflecting the average across all items, range from 0-7, with higher scores representing more flexible/greater perceived pathways to solving one's problems.

Time frame: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

Change in Beck Hopelessness Scale - 4 Item Version

4 item version (BHS-4; referenced as 'How I Think Scale' in appended materials): This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Average scores across all items range from 0 to 3, with a higher score indicating greater levels of hopelessness.

Time frame: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

Program Feedback Scale

The PFS asks youth to rate agreement with 7 statements indicating perceived acceptability of an SSI (e.g. "I enjoyed the program") on a 5-point Likert scale (1="really disagree"; 5="totally agree"). A score of 3.5/5 or above on any given PFS item is interpreted as an "acceptable" rating on that item. Scores are calculated at the item-level, and higher scores reflect greater acceptability for each item.

Time frame: Immediately Post-SSI only