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

NCT ID: NCT04634903

Last Updated: 2021-05-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-03-15

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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Supportive Therapy SSI (ST-SSI)

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.

Group Type ACTIVE_COMPARATOR

Supportive Therapy SSI

Intervention Type BEHAVIORAL

Online, 30-minute self-administered program for youth

Behavioral Activation SSI (BA-SSI)

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.

Group Type EXPERIMENTAL

Behavioral Activation SSI

Intervention Type BEHAVIORAL

Online, 30-minute self-administered program for youth

Growth Mindset SSI (GM-SSI)

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.

Group Type EXPERIMENTAL

Growth Mindset SSI

Intervention Type BEHAVIORAL

Online, 30-minute self-administered program for youth

Interventions

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Supportive Therapy SSI

Online, 30-minute self-administered program for youth

Intervention Type BEHAVIORAL

Behavioral Activation SSI

Online, 30-minute self-administered program for youth

Intervention Type BEHAVIORAL

Growth Mindset SSI

Online, 30-minute self-administered program for youth

Intervention Type BEHAVIORAL

Other Intervention Names

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Sharing Feelings SSI ST-SSI Activate Action BA-SSI Project Personality GM-SSI

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 \[PHQ-2\])

* 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Denver

OTHER

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Schleider

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica L Schleider, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37931065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37183368 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36323056 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34887544 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1505797-3

Identifier Type: -

Identifier Source: org_study_id

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