CClinicalTrials.gg
CompletedNCT06359951Updated Jun 5, 2026

Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

An interventional study of Project YES in Depression, Eating Disorders and Anxiety, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 1 site in United States. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
13 Years to 25 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Depression
  • Eating Disorders
  • Anxiety
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 37 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Project YES

    This 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

    Behavioral: Project YES

Interventions

  • BehavioralProject YES

    Digital SSI

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What researchers measure

Primary outcomes

  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).

    Time frame: 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.

    Time frame: 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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: Immediately after the intervention

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Study locations

1 site
  • Ann & Robert H Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06359951
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
American Psychological Association (APA)
Responsible party
Anna Ros (Assistant Professor, Adolescent and Young Adult Psychologist, Ann & Robert H Lurie Children's Hospital of Chicago) — Principal investigator
First posted
Apr 11, 2024
Start date
Aug 8, 2024
Primary completion
Dec 6, 2025
Completion
Jan 23, 2026
Last update
Jun 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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