[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04822636":3,"trial-entities:NCT04822636":86,"trial-summary:NCT04822636":89},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":67,"locations":69,"central_contacts":79,"overall_officials":80,"references":84,"see_also_links":85},"NCT04822636","1929675","Family Mental Health Family Navigator Project (FMHN)","Family Mental Health Family Navigator","COMPLETED","2025-12-01","2026-08","2026-08-11","2022-06-06","University of California, San Francisco","OTHER",true,"This study will focus on developing and testing a family-based mental health navigator intervention, the Family Mental Health Navigator (FMHN), to evaluate whether the intervention combined with mHealth is preliminary efficacious in improving mental health service initiation and engagement for publicly-insured youth.","The study will demonstrate how a family-based navigator intervention combined with mHealth may lead to improved mental health treatment initiation and engagement among publicly-insured youth. Publicly-insured youth have high rates of mental health symptoms relative to youth in the community, and are disproportionately racial and ethnic minorities, only perpetuating disparities in this population's mental health access and engagement. The proposed project will develop and test a family-based navigator intervention, the Family Mental Health Navigator (FMHN), a natural fit for improving publicly-insured youth's mental health service and clinical outcomes. The study will start with identifying the feasibility and acceptability of the FMHN intervention. Then, the study will determine whether the FMHN intervention improves publicly-insured youth mental health treatment initiation and engagement. Finally, the study will characterize patterns of pre- and post-service outcomes along the behavioral health services cascade of care, to further evaluate the feasibility, acceptability, and preliminary impact of the FMHN model.",[19],"Mental Health",[21,22,19,23,24,25],"Adolescent","Publicly-insured Youth","Navigator Service","Access","Children","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},33,"ACTUAL",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Family-based mental health navigation","Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement",[36],[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Time to treatment referral","Number of days until treatment referral is made","12 months post enrollment",{"measure":45,"description":46,"timeFrame":43},"Time to treatment initiation","Number of days until attendance at first treatment session",{"measure":48,"description":49,"timeFrame":43},"Treatment engagement","Engagement as measured by attendance in treatment for 6 or more weeks",[],"ALL","6 Years","17 Years",{"inclusion":55,"exclusion":62,"raw_text":66},[56,57,58,59,60,61],"English-speaking and\u002For Spanish-speaking youth","Ages 6-17","Are currently receiving services at the San Francisco General Hospital","Are publicly insured","Have an involved caregiver\u002Flegal guardian for consent","Family has mobile phone access",[63,64,65],"Youth is not English-speaking nor Spanish-speaking","Caregiver has impairment that would preclude providing informed consent","Unavailable guardian for consent","Inclusion Criteria:\n\n* English-speaking and\u002For Spanish-speaking youth\n* Ages 6-17\n* Are currently receiving services at the San Francisco General Hospital\n* Are publicly insured\n* Have an involved caregiver\u002Flegal guardian for consent\n* Family has mobile phone access\n\nExclusion Criteria:\n\n* Youth is not English-speaking nor Spanish-speaking\n* Caregiver has impairment that would preclude providing informed consent\n* Unavailable guardian for consent",[68],"CHILD",[70],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"UCSF Zuckerberg San Francisco General Hospital","San Francisco","California","94131","United States",{"lat":77,"lon":78},37.77493,-122.41942,[],[81],{"name":82,"affiliation":13,"role":83},"Marina Tolou-Shams, Ph.D","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":88},[19],[],{"nct_id":4,"found":15,"summary":90,"prompt_version":99},{"design":91,"status":92,"heading":6,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an interventional study planning to enroll 150 participants. It is testing a behavioral intervention.","completed","This study, called the Family Mental Health Family Navigator Project (FMHN), is testing a family-based mental health navigation program combined with mobile health (mHealth) practices. The goal is to see if this program can help publicly-insured youth, aged 6 to 17, start and stay engaged with mental health treatment. You might be able to join if you are between 6 and 17, speak English or Spanish, are currently receiving services at San Francisco General Hospital, have public insurance, and your family has mobile phone access. The researchers will measure how quickly youth get referred to treatment, start treatment, and stay engaged with treatment over 12 months. The current status of this study is unclear.","Participants will be followed for 12 months after enrollment to measure treatment referral, initiation, and engagement.",114,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]