[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661901":3,"trial-entities:NCT07661901":97,"trial-summary:NCT07661901":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":47,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":72,"locations":74,"central_contacts":91,"overall_officials":93,"references":95,"see_also_links":96},"NCT07661901","45392554 (26-0255)","Reward Sensitivity Digital Intervention for Suicide Risk","Pilot Development of a Youth-Focused Digital Just-in-Time Adaptive Intervention to Enhance Reward Sensitivity and Reduce Suicidal Ideation","RECRUITING","2027-09","2026-06","2026-06-22","University of Pennsylvania","OTHER",false,"The goal of this clinical trial is to develop and test an app designed to reduce suicide risk and improve emotional well-being in adolescents. The study will test if the app's daily check ins and recommended mood boosting skills will improve the adolescent's overall mood and suicidality. The main question it aims to answer is:\n\n• Is the app practical and acceptable to use daily?\n\nIn the study, adolescents will:\n\n* Participate in a focus group with other adolescents and provide feedback on the app itself (design, ease of use, etc.).\n* Complete surveys and assessments on their mood, thoughts, and experiences.\n* Complete assessments about their app experience.\n\nIn the study, the legal guardian of the adolescent will:\n\n* Participate in a focus group with other adolescents and provide feedback on the app itself (design, ease of use, etc.).\n* Complete assessments about their app experience.","Adolescent suicide remains a major concern, and current treatments and prevention approaches are not effective for all adolescents. Some adolescents, particularly those who have difficulty experiencing pleasure or positive emotions (anhedonia), may be at increased risk for suicidal thoughts and may benefit less from existing interventions. This study aims to address this gap by developing and testing a digital intervention designed to improve reward sensitivity, increase positive emotions, and reduce suicidal thoughts in adolescents.\n\nThe intervention uses a just-in-time adaptive intervention approach, meaning that participants receive brief support activities and coping tools on their smartphone throughout the day. These activities are designed to promote healthy reward-seeking behaviors, improve mood, and provide support during moments when adolescents may be especially open to intervention. The study also uses ecological momentary assessments, which are short real-time surveys completed multiple times per day to measure mood, motivation, thoughts, context, and daily experiences.\n\nThe study will be conducted in multiple phases. The study is currently recruiting for Phase 1. In Phase 1, adolescents and their legal guardians will participate in a co-design process and provide feedback on the digital platform and intervention content to improve usability and acceptability.\n\nParticipants will complete interviews, questionnaires, and digital assessments related to mood, emotions, reward sensitivity, coping behaviors, and suicidal thoughts. Findings from this study will help inform future digital suicide prevention interventions for adolescents.",[18,19,20,21,22,23],"Suicidal Ideation","Suicidal","Suicidal Thoughts","Digital Health Intervention","Reward Sensitivity","Anhedonia",[25,26,27,28,29,30,31,32,22,23],"Adolescents","Legal Guardians","Digital","Philadelphia","Suicide","Intervention","Prevention","Dyads","INTERVENTIONAL","TREATMENT",[36],"NA",{"count":38,"type":39},20,"ESTIMATED",[41],{"type":42,"name":43,"description":44,"otherNames":45},"BEHAVIORAL","Suicide prevention treatment","Digital just-in-time adaptive intervention to enhance reward sensitivity and reduce suicidal ideation",[46],"DIGIReward",[48,52],{"measure":49,"description":50,"timeFrame":51},"Acceptability of Digital Suicide Prevention Intervention","At least 80% of youth will report in qualitative feedback that the digital suicide prevention intervention is helpful and relevant to their daily lives.","Day 1 (Focus Group)",{"measure":53,"description":54,"timeFrame":51},"Usability of Digital Suicide Prevention Intervention","The digital suicide prevention intervention prototype will exceed established usability benchmarks, as measured by the System Usability Scale (SUS; range = 0-100, with higher scores indicating greater perceived usability), with a mean SUS score of at least 70.",[],"ALL","13 Years","17 Years",{"inclusion":60,"exclusion":67,"raw_text":71},[61,62,63,64,65,66],"Aged 13-17 years old","Recent suicidal ideation","Access to a smartphone device","Residing in the Philadelphia metropolitan area","They are the legal guardian of an adolescent that meets all study criteria (see above)","They can read, write, and speak English",[68,69,70],"Psychotic disorder, including schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified, with a past year psychotic episode prior to baseline","Bipolar disorder I diagnosis, with a past year manic episode prior to baseline","Imminent suicide risk (e.g., active suicidal ideation with a specific plan and intent)","Inclusion Criteria:\n\nADOLESCENTS\n\n* Aged 13-17 years old\n* Recent suicidal ideation\n* Access to a smartphone device\n* Residing in the Philadelphia metropolitan area\n\nLEGALGUARDIANS\n\n* They are the legal guardian of an adolescent that meets all study criteria (see above)\n* They can read, write, and speak English\n\nExclusion Criteria:\n\nADOLESCENTS\n\n* Psychotic disorder, including schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified, with a past year psychotic episode prior to baseline\n* Bipolar disorder I diagnosis, with a past year manic episode prior to baseline\n* Imminent suicide risk (e.g., active suicidal ideation with a specific plan and intent)\n\nLEGALGUARDIANS\n\n\\- There are no exclusion criteria for legal guardians",[73],"CHILD",[75],{"facility":12,"status":8,"city":28,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":88},"Pennsylvania","19104","United States",[80,85],{"name":81,"role":82,"phone":83,"email":84},"Sydney Lempert, B.A.","CONTACT","215-746-3337","Sydney.Lempert@Pennmedicine.upenn.edu",{"name":86,"role":87},"Marin Kautz, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},39.95238,-75.16362,[92],{"name":81,"role":82,"phone":83,"email":84},[94],{"name":86,"affiliation":12,"role":87},[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[18],[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study with a planned enrollment of 20 participants. It is currently in Phase 1, focusing on co-design and feedback.","completed","Digital Intervention for Adolescent Suicide Risk","This study is developing and testing a smartphone app called a \"Digital just-in-time adaptive intervention\" to help teenagers (ages 13-17) who are having suicidal thoughts. The app aims to improve their ability to experience pleasure and positive emotions, which can reduce suicidal thoughts. Researchers want to know if the app is practical and easy to use daily. You might be able to join if you are a teenager living in the Philadelphia area, have recently had suicidal thoughts, and have a smartphone. The study is currently recruiting for its first phase, where participants will give feedback on the app's design and content.","Acceptability and usability of the intervention will be measured on Day 1 (Focus Group).",102,"Adolescents will participate in a focus group, provide feedback on the app, and complete surveys and assessments on their mood and app experience.","Not stated in the trial record.",[],"v2"]