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

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Two Online Single-Session Interventions for Adolescent Depression: Outcomes of a Randomized Trial

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: 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.

Ages Eligible for Study
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Minimum Age: 13 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 to the Behavioral Activation SSI (BA-SSI), Growth Mindset SSI (GM-SSI), or the Supportive Therapy SSI (ST-SSI; each 30 minutes in length).
Masking: Double


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 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. | Pre-SSI to 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Immediately Post-SSI only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single-session interventions