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DepressionNCT06359951

Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

A study testing Project YES in people with Depression and Eating Disorders, run by Ann & Robert H Lurie Children's Hospital of Chicago 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

This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Read more about this study

Who is it for?
Ages 13 to 25 years
Conditions the study is for
Depression, Eating Disorders, Anxiety
What is being tested?
Project YES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
8 Aug 2024to 23 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • a score >5 on the PHQ-9 OR a score >5 on the GAD-7
  • patient at Lurie Division of Adolescent and Young Adult Medicine
  • provider agreement that this would be an appropriate intervention
  • age between 13 and 25
  • comfort speaking and reading in either English or Spanish

Who cannot join

  • inability to speak and understand English or Spanish
  • imminent risk for suicide as indicated by a "Yes" response to questions #5 on the Ask Suicide Questions (ASQ) Screener

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Implementation of Digital Brief, Scalable Single Session Interventions in Specialty Adolescent Care

This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety, as well as eating disorder symptoms.

Being tested
Project YES
Medical subject headings
Depression, Feeding and Eating Disorders, Anxiety Disorders

What participants receive

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

  • Project YESBehavioural

    Digital SSI

Study groups in NCT06359951
Study groupRoleWhat they receive
Project YESExperimentalThis is a digital, self-guided SSI that has 3 options, Project Personality, Project CARE, and the ABC project. These teach adolescents about CBT skills including growth mindset, neutral self-talk and behavioral activation. Each option contains self-reflection exercises, vignettes from fictional peers, and psychoeducation that support users in understanding each CBT skill. See all materials for this intervention here: https://www.schleiderlab.org/yes.html
Receives: Behavioral: Project YES

What is being measured

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

  1. Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)

    A 13-item questionnaire designed to assess depressive symptoms in youth. Total scores range from 0 to 26, with higher scores indicating greater depression severity (primary outcome).

    Measured: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up

  2. Patient Health Questionnaire-9 (PHQ-9)

    A 9 item questionnaire that objectifies and assesses degree of depression severity. Total scores range from 0 to 27, with higher scores indicating greater depression severity.

    Measured: Pre-Intervention (baseline), 12-week follow-up

  3. Generalized Anxiety Disorder -7 (GAD-7)

    A 7 item questionnaire that measures severity of anxiety, mainly in outpatients. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.

    Measured: Pre-Intervention (baseline), 12-week follow-up

Secondary outcomes (5)

  1. Dietary Restriction Screener - 2 (DRS 2)

    This is a a single-item screener designed to identify individuals recently engaging in problematic restriction. The single item is "Have there been any times within the past month when you have eaten in this manner because you were concerned about your body shape and/or weight?" and has participants respond with a yes or a no.

    Measured: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up

  2. Adult State Hope Scale

    The 3-item State Hope Scale is a a dispositional self-report measure of agency. This scale can range from 3 to 24, with higher scores indicating higher levels of agency thinking.

    Measured: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up

  3. Self-Hate Scale

    The 7-item Self-Hate Scale is a brief, psychometrically valid measure of self-hate. Total scores are calculated as the mean of all items and scores are coded such that higher ratings indicate higher levels of self-hate (range 1-7).

    Measured: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up

  4. Beck Hopelessness -4

    This four-item scale measures major aspects of hopelessness using true/false questions examining the respondent's attitude for the past week. This scale ranges from 0-4 such that higher scores reflect higher levels of hopelessness.

    Measured: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up

  5. Program Feedback Scale

    The program feedback scale asks participants to rate agreement with seven statements indicating perceived acceptability and feasibility of their selected SSI (eg, "I enjoyed the program") on a 5-point Likert scale (1="really disagree"; 5="totally agree"). Means and standard deviations are calculated for each item (range 0-7), with a mean of 3.5 for each item indicating acceptability and feasibility.

    Measured: Immediately after the intervention

Timeline

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

  1. First posted11 Apr 2024
  2. Study start8 Aug 2024
  3. Primary completion6 Dec 2025
  4. Study completion23 Jan 2026

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359951
Sponsor's protocol ID
24-0103
Status last verified
Jan 2026
First submitted
29 Mar 2024
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perczel Forintos D, Rozsa S, Pilling J, Kopp M. Proposal for a short version of the Beck Hopelessness Scale based on a national representative survey in Hungary. Community Ment Health J. 2013 Dec;49(6):822-30. doi: 10.1007/s10597-013-9619-1. Epub 2013 Jun 12.

    PubMed 23756722

  • Schleider JL, Mullarkey MC, Weisz JR. Virtual Reality and Web-Based Growth Mindset Interventions for Adolescent Depression: Protocol for a Three-Arm Randomized Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13368. doi: 10.2196/13368.

    PubMed 31290406

  • Schleider J, Weisz J. A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. J Child Psychol Psychiatry. 2018 Feb;59(2):160-170. doi: 10.1111/jcpp.12811. Epub 2017 Sep 18.

    PubMed 28921523

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Haynos AF, Fruzzetti AE. Initial evaluation of a single-item screener to assess problematic dietary restriction. Eat Weight Disord. 2015 Sep;20(3):405-13. doi: 10.1007/s40519-014-0161-0. Epub 2014 Nov 21.

    PubMed 25412874

  • Beard C, Hsu KJ, Rifkin LS, Busch AB, Bjorgvinsson T. Validation of the PHQ-9 in a psychiatric sample. J Affect Disord. 2016 Mar 15;193:267-73. doi: 10.1016/j.jad.2015.12.075. Epub 2015 Dec 31.

    PubMed 26774513

  • Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.

    PubMed 8636885

  • Eyre O, Bevan Jones R, Agha SS, Wootton RE, Thapar AK, Stergiakouli E, Langley K, Collishaw S, Thapar A, Riglin L. Validation of the short Mood and Feelings Questionnaire in young adulthood. J Affect Disord. 2021 Nov 1;294:883-888. doi: 10.1016/j.jad.2021.07.090. Epub 2021 Jul 29.

    PubMed 34375216

Questions about this trial

What is this clinical trial studying?

A study testing Project YES in people with Depression and Eating Disorders, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 5 inclusion and 2 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 5 Jun 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995) (time frame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up). The study lists 3 primary outcomes in all. 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 NCT06359951, which also lists 8 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 5 Jun 2026.

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