Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

Not Applicable

• Conditions: Anxiety; Eating Disorders; Depression
• Interventions: Behavioral: Project YES

• Registration Number: NCT06359951
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Study Start: 2024-08-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-04-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Project YES	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

Primary Outcome Measures

Name	Time	Method
Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up	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).
Patient Health Questionnaire-9 (PHQ-9)	Pre-Intervention (baseline), 12-week follow-up	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.
Generalized Anxiety Disorder -7 (GAD-7)	Pre-Intervention (baseline), 12-week follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Program Feedback Scale	Immediately after the intervention	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.
Adult State Hope Scale	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up	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.
Beck Hopelessness -4	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up	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.
Dietary Restriction Screener - 2 (DRS 2)	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up	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.
Self-Hate Scale	Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up	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).

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States