Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

NCT06359951 | Enrolling By Invitation

• 1 other identifier: 24-0103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 and eating disorder symptoms.

Conditions

Depression; Eating Disorders; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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).

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

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Dietary Restriction Screener - 2 (DRS 2)

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

• Adult State Hope Scale

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

• Self-Hate Scale

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

• Beck Hopelessness -4

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

• Program Feedback Scale

  Immediately after the intervention

Study Arms (1)

Project YES

EXPERIMENTAL

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

Project YES BEHAVIORAL

Digital SSI

Project YES

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology: collaborator

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 23756722 BACKGROUND

• 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.

  PMID: 31290406 BACKGROUND

• 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.

  PMID: 28921523 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 25412874 BACKGROUND

• 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.

  PMID: 26774513 BACKGROUND

• 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.

  PMID: 8636885 BACKGROUND

• 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.

  PMID: 34375216 BACKGROUND

MeSH Terms

Conditions

Depression; Feeding and Eating Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Adolescent and Young Adult Psychologist

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: August 8, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (1)