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DepressionNCT04634903

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

A study testing Supportive Therapy SSI, Behavioral Activation SSI and Growth Mindset SSI in people with Depression, run by Stony Brook University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 16 years
Conditions the study is for
Depression
What is being tested?
Supportive Therapy SSI, Behavioral Activation SSI and Growth Mindset SSI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,452 participants
Where
1 siteUnited States
Study dates
19 Nov 2020to 15 Mar 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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])

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stony Brook University

    Stony Brook, New York, 11790

Other trials in United States

About this study

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

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
Being tested
Supportive Therapy SSI, Behavioral Activation SSI, Growth Mindset SSI
Keywords
single-session interventions
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Therapy SSIBehavioural

    Also called Sharing Feelings SSI, ST-SSI

    Online, 30-minute self-administered program for youth

  • Behavioral Activation SSIBehavioural

    Also called Activate Action, BA-SSI

    Online, 30-minute self-administered program for youth

  • Growth Mindset SSIBehavioural

    Also called Project Personality, GM-SSI

    Online, 30-minute self-administered program for youth

Study groups in NCT04634903
Study groupRoleWhat they receive
Supportive Therapy SSI (ST-SSI)Active comparatorThe 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.
Receives: Behavioral: Supportive Therapy SSI
Behavioral Activation SSI (BA-SSI)ExperimentalThe 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.
Receives: Behavioral: Behavioral Activation SSI
Growth Mindset SSI (GM-SSI)ExperimentalProgram 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.
Receives: Behavioral: Growth Mindset SSI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-SSI to 3-month follow-up

Secondary outcomes (3)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: Immediately Post-SSI only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start19 Nov 2020
  3. Primary completion15 Mar 2021
  4. Study completion15 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
2,452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634903
Sponsor's protocol ID
1505797-3
Status last verified
May 2021
First submitted
11 Nov 2020
Last updated
25 May 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 37931065

  • 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.

    PubMed 37183368

  • 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.

    PubMed 36323056

  • 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.

    PubMed 34887544

Questions about this trial

What is this clinical trial studying?

A study testing Supportive Therapy SSI, Behavioral Activation SSI and Growth Mindset SSI in people with Depression, run by Stony Brook University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Adolescent Depressive Symptom Severity (time frame: Pre-SSI to 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04634903, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.

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Clinical Trial NCT04634903 | AzTrials