Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06359951
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2024-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-03-29', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)', 'timeFrame': 'Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up', 'description': '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).'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Pre-Intervention (baseline), 12-week follow-up', 'description': '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.'}, {'measure': 'Generalized Anxiety Disorder -7 (GAD-7)', 'timeFrame': 'Pre-Intervention (baseline), 12-week follow-up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Dietary Restriction Screener - 2 (DRS 2)', 'timeFrame': 'Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up', 'description': '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.'}, {'measure': 'Adult State Hope Scale', 'timeFrame': 'Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up', 'description': '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.'}, {'measure': 'Self-Hate Scale', 'timeFrame': 'Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up', 'description': '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).'}, {'measure': 'Beck Hopelessness -4', 'timeFrame': 'Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up', 'description': "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."}, {'measure': 'Program Feedback Scale', 'timeFrame': 'Immediately after the intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Eating Disorders', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '23756722', 'type': 'BACKGROUND', '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.'}, {'pmid': '31290406', 'type': 'BACKGROUND', '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.'}, {'pmid': '28921523', 'type': 'BACKGROUND', '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.'}, {'pmid': '16717171', 'type': 'BACKGROUND', '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.'}, {'pmid': '25412874', 'type': 'BACKGROUND', '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.'}, {'pmid': '26774513', 'type': 'BACKGROUND', '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.'}, {'pmid': '8636885', 'type': 'BACKGROUND', '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.'}, {'pmid': '34375216', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a score \\>5 on the PHQ-9 OR a score \\>5 on the GAD-7\n* patient at Lurie Division of Adolescent and Young Adult Medicine\n* provider agreement that this would be an appropriate intervention\n* age between 13 and 25\n* comfort speaking and reading in either English or Spanish\n\nExclusion Criteria:\n\n* inability to speak and understand English or Spanish\n* imminent risk for suicide as indicated by a "Yes" response to questions #5 on the Ask Suicide Questions (ASQ) Screener'}, 'identificationModule': {'nctId': 'NCT06359951', 'briefTitle': 'Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Implementation of Digital Brief, Scalable Single Session Interventions in Specialty Adolescent Care', 'orgStudyIdInfo': {'id': '24-0103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Project YES', 'description': '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.\n\nSee all materials for this intervention here: https://www.schleiderlab.org/yes.html', 'interventionNames': ['Behavioral: Project YES']}], 'interventions': [{'name': 'Project YES', 'type': 'BEHAVIORAL', 'description': 'Digital SSI', 'armGroupLabels': ['Project YES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'collaborators': [{'name': 'American Psychological Association Division 53 Society for Clinical Child & Adolescent Psychology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Adolescent and Young Adult Psychologist', 'investigatorFullName': 'Anna Ros', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}