Clinical trial NCT06359951: Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine
Official title: Implementation of Digital Brief, Scalable Single Session Interventions in Specialty Adolescent Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Eating Disorders
Anxiety
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)
timeFrame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pre-Intervention (baseline), 12-week follow-up
measure: Generalized Anxiety Disorder -7 (GAD-7)
timeFrame: Pre-Intervention (baseline), 12-week follow-up
Secondary outcomes:
measure: Dietary Restriction Screener - 2 (DRS 2)
timeFrame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
measure: Adult State Hope Scale
timeFrame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
measure: Self-Hate Scale
timeFrame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
measure: Beck Hopelessness -4
timeFrame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up
measure: Program Feedback Scale
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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.
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.
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.