Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

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 and eating disorder symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Eating Disorders
• Intervention / Treatment: Behavioral: Project YES

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago
      • Contact: Anna M Ros, PhD; Phone Number: 312-227-5433; Email: annaros@luriechildrens.org
      • Contact: Lisa Kuhns, PhD; Phone Number: 312-227-6119; Email: lkuhns@luriechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; Digital SSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
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.	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
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).	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
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.	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
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.	Immediately after the intervention

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 24-0103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No