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

NCT04634903 | Completed Results

• 1 other identifier: 1505797-3
• Study Type: interventional
• Target: 2,452
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

single-session interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in State Hope Scale - Pathways Subscale

  Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

• Change in Beck Hopelessness Scale - 4 Item Version

  Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

• Program Feedback Scale

  Immediately Post-SSI only

Other Outcomes (16)

• Change in Behavioral Activation for Depression Scale - Short Form

  Pre-SSI to 3-month follow-up

• Change in Self-Injurious Thoughts and Behaviors Interview-Short Form (SITBI-SF)

  Pre-SSI to 3-month follow-up

• Change in Implicit Personality Theory Questionnaire

  Pre-SSI, Immediately Post-SSI

Study Arms (3)

Supportive Therapy SSI (ST-SSI)

ACTIVE COMPARATOR

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

Behavioral Activation SSI (BA-SSI)

EXPERIMENTAL

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

Growth Mindset SSI (GM-SSI)

EXPERIMENTAL

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

Interventions

Supportive Therapy SSI BEHAVIORAL

Online, 30-minute self-administered program for youth

Also known as: Sharing Feelings SSI, ST-SSI

Supportive Therapy SSI (ST-SSI)

Behavioral Activation SSI BEHAVIORAL

Online, 30-minute self-administered program for youth

Also known as: Activate Action, BA-SSI

Behavioral Activation SSI (BA-SSI)

Growth Mindset SSI BEHAVIORAL

Online, 30-minute self-administered program for youth

Also known as: Project Personality, GM-SSI

Growth Mindset SSI (GM-SSI)

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[PHQ-2\])

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead
• University of Denver: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11790, United States

Location

Related Publications (4)

• Szkody E, Chang YW, Schleider JL. Serving the Underserved? Uptake, Effectiveness, and Acceptability of Digital SSIs for Rural American Adolescents. J Clin Child Adolesc Psychol. 2025 Sep-Oct;54(5):541-554. doi: 10.1080/15374416.2023.2272935. Epub 2023 Nov 6.

  PMID: 37931065 DERIVED

• Ahuvia IL, Mullarkey MC, Sung JY, Fox KR, Schleider JL. Evaluating a treatment selection approach for online single-session interventions for adolescent depression. J Child Psychol Psychiatry. 2023 Dec;64(12):1679-1688. doi: 10.1111/jcpp.13822. Epub 2023 May 14.

  PMID: 37183368 DERIVED

• 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.

  PMID: 36323056 DERIVED

• 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.

  PMID: 34887544 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Jessica Schleider
• Organization: Stony Brook University

jessica.schleider@stonybrook.edu

917-439-1872

Study Officials

• Jessica L Schleider, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: 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).

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: November 19, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: May 25, 2021
• Results First Posted: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Protocol and statistical plan have been posted to Open Science Framework prior to the start of this trial as part of study pre-registration (https://osf.io/kumdv/). Code will be made available upon publication of trial results.

Locations

US (1)