[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04729504":3,"trial-entities:NCT04729504":89,"trial-summary:NCT04729504":93},{"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":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":47,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":82,"overall_officials":85,"references":87,"see_also_links":88},"NCT04729504","20210016","Cultural Adaptation of a SSI for Youth Anxiety","Cultural Adaptation and Dissemination of a Single-Session Intervention (SSI) Targeting Caregivers of Youth With Anxiety","RECRUITING","2026-12-21","2025-12","2025-12-18","2021-03-08","University of Miami","OTHER",false,"The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.",null,[19],"Anxiety Disorders",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},2000,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Adapted Project BRAVE","A culturally and linguistically adapted Project BRAVE is web-based single session intervention that is about 30 minutes in length. The session is designed to focus on targeting child anxiety symptoms in the multilingual and diverse families in Miami-Dade.",[34],"Adapted Project BRAVE Group",[36,40,43],{"measure":37,"description":38,"timeFrame":39},"Change in anxiety as measured by GAD-2","Generalized Anxiety Disorder 2-item (GAD-2) Scale has a total score ranging from 0 to 6 with a score of 3 being the cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted.","Baseline, 2 weeks",{"measure":41,"description":42,"timeFrame":39},"Change in anxiety as measured by the FASA","Family Accommodation Scale - Anxiety (FASA) is a 9-item scale of measuring caregiver accommodation behaviors (modification of routines, facilitating avoidance, etc.) in light of youth anxiety. It has a total score ranging from 0 to 36 with the higher score indicating more frequent parental accommodation.",{"measure":44,"description":45,"timeFrame":46},"Program Feedback Scale (PFS) Scores","The PFS is a reliable, valid measure of the perceived acceptability of single-session interventions. It asks participants to rate acceptability and feasibility of an SSI they just completed. It has a total score ranging from 0 to 28 with the higher score indicating perceived acceptability and feasibility of the program.","2 weeks",[48,51],{"measure":49,"description":50,"timeFrame":46},"Perceived Change in Problem-Solving, and Preparedness to Manage Distress","Two questions (Schleider et al., 2020) will be used to assess change in ability to solve problems, and ability to manage distress. Participants will be asked, \"to what extent are you able to solve the problems \\[with your child's anxiety\\] facing right now?\", and \"how prepared do you feel to manage \\[your child with\\] distressing situations?\" It has a total score ranging from 2 to 10, with a higher score indicating better ability to solve problems, and to manage distress.",{"measure":52,"description":53,"timeFrame":39},"Change in State Hope Scale Scores","State Hope Scale is a 6-item self-report scale designed to evaluate hope in adolescents and adults, including two reliable subscales: agency and pathways. It has a total score ranging from 6 to 48 with the higher scores representing higher hope levels.","ALL","18 Years",true,{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\n1. Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.\n2. Affirm that they have read the consent language and study overview on REDCap by checking a box.\n\nExclusion Criteria:\n\n\\- Not meet all of the inclusion criteria.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":13,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":79},"Miami","Florida","33136","United States",[71,76],{"name":72,"role":73,"phone":74,"email":75},"Hannah Grassie","CONTACT","305-284-2712","hlg54@miami.edu",{"name":77,"role":78},"Jill Ehrenreich-May","PRINCIPAL_INVESTIGATOR",{"lat":80,"lon":81},25.77427,-80.19366,[83],{"name":84,"role":73,"phone":74,"email":75},"Hannah Grassie, BA",[86],{"name":77,"affiliation":13,"role":78},[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Anxiety Disorder",[],{"nct_id":4,"found":56,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 2000 participants.","completed","Culturally Adapted Web-Based Intervention for Youth Anxiety","This study is testing an intervention called Adapted Project BRAVE, a web-based program about 30 minutes long. It's designed to help children aged 4-10 with anxiety by adapting to the cultural and language diversity of Latin, Haitian, and Haitian-American families in Miami-Dade. The study aims to see if this program can reduce anxiety symptoms, measured by questionnaires like GAD-2 and FASA, and gather feedback on the program. You can join if you are a caregiver (parent or legal guardian) of a child aged 4-10 and agree to the study terms. The study plans to enroll 2000 participants, but its current recruitment status is unclear.","Your child's anxiety levels and program feedback will be measured at 2 weeks after the intervention.",104,"You would participate in a single 30-minute web-based session. You would also complete questionnaires at the start and after 2 weeks.","Not stated in the trial record.",[31],"v2"]