Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359951
• Other study ID #: 24-0103
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 31, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Project YES
Digital SSI

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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