N/A
Completed N=2,452
Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19
Source: ClinicalTrials.gov NCT04634903 ↗Enrolled (actual)
2,452
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Change in Adolescent Depressive Symptom Severity — 14.31; 14.15; 14.22; 12.57 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Adolescent Depressive Symptom Severity |
14.31; 14.15; 14.22; 12.57; 11.47; 11.58 | — |
| SECONDARY Change in State Hope Scale - Pathways Subscale |
3.88; 3.93; 3.96; 5.26; 5.68; 5.50 | — |
| SECONDARY Change in Beck Hopelessness Scale - 4 Item Version |
1.71; 1.72; 1.72; 1.36; 1.22; 1.21 | — |
| SECONDARY Program Feedback Scale |
3.80; 3.93; 3.83; 4.54; 4.46; 4.48 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04634903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.