[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651053":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)","EXPERIMENTAL","Participants receive a structured, 12-week Cognitive Behavioral Therapy program adapted for autistic youth, targeting depressive symptoms and underlying mechanisms such as emotional reactivity and self-esteem.\n\nTherapy is delivered by trained clinicians with weekly sessions and includes assessments at baseline, mid-treatment, post-treatment, and follow-up.",[13],"Behavioral: CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth)",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment-as-Usual (TAU)","ACTIVE_COMPARATOR","Participants receive standard outpatient mental health care, typically consisting of supportive, talk-based therapy provided by clinicians without CBT-DAY training.\n\nParticipants complete the same assessment schedule as the experimental arm across baseline, treatment, and follow-up timepoints.",[19],"Behavioral: Treatment-as-Usual (TAU)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","CBT-DAY (Cognitive Behavioral Therapy for Depression in Autistic Youth) is a 12-week, autism-adapted cognitive behavioral therapy designed for verbally fluent autistic youth aged 11-17 to reduce depressive symptoms.\n\nThe intervention targets key mechanisms-emotional reactivity, negative self-esteem, and autism self-knowledge-using developmentally tailored CBT strategies appropriate for autistic individuals.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Treatment-as-Usual (TAU) consists of standard clinical care delivered by clinicians with limited autism training in the same outpatient setting.\n\nIt typically involves supportive, talk-based psychotherapy without the structured, autism-adapted components of CBT-DAY.",[15],[30],{"name":31,"affiliation":5,"role":32},"Jessica Schwartzman, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","323-207-5910","trendlab@chla.usc.edu",[39],{"facility":5,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Los Angeles","California","90027","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.24368,34.05223,{"lat":49,"lon":48},[52,53],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jessica Schwartzman","Director, Training and Research to Empower NeuroDiversity (TREND) Lab, CHLA",[58],{"name":59,"class":60},"National Institute of Mental Health (NIMH)","NIH","100651053","feasibility-acceptability-and-preliminary-effectiveness-of-cognitive-behavioral-therapy-for-depression-in-autistic-youth-in-clinical-settings-100651053",false,"NCT07755137","Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings","CBT-DAY","Inclusion Criteria:\n\nAutistic youth:\n\n* Age 11 to 17 years\n* Prior clinical diagnosis of autism (per record review)\n* At least a fifth grade reading level\n* An ability to engage in sessions verbally (i.e., full length sentences)\n* Elevated symptoms of depression at baseline (RCADS)\n* Depression is a current clinical concern and participant is appropriate for intervention (per investigator determination)\n* At least one parent\u002Fcaregiver willing and able to participate\n* Eligible to receive services at CHLA\n* If taking psychotropic medication, regimen must be stable for at least 8 weeks prior to baseline\n\nParents\u002FCaregivers:\n\n* Age 18 years or older\n* Parent or legal guardian of participating youth\n* Able to provide informed consent\n* Comfortable reading, writing, or speaking English or Spanish\n* Willing to participate in study procedures\n\nExclusion Criteria:\n\nAutistic youth:\n\n* Lifetime diagnosis of bipolar disorder, psychotic disorder, or intellectual disability\n* Severe suicidal or homicidal ideation or self-injury requiring immediate higher-level care\n* Currently receiving psychotherapy for depression\n* Changes in psychotropic medication regimen during study participation (participants may be withdrawn)\n* A reading level below fifth-grade\n* An inability to engage in sessions verbally (i.e., nonverbal, minimally verbal)\n\nParents\u002FCaregivers:\n\n* Not the parent or legal guardian of the participating youth\n* Unable to provide informed consent\n* Not comfortable reading, writing, or speaking English or Spanish\n* Unwilling to participate in study procedures","ALL","11 Years","17 Years",{"count":72,"type":73},140,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings.\n\nThe main questions it aims to answer are:\n\n* Does CBT-DAY lead to greater reductions in depressive symptom severity compared to treatment-as-usual (TAU)?\n* Does CBT-DAY improve key mechanisms (emotional reactivity, self-esteem, and autism self-knowledge) associated with depression outcomes?\n\nResearchers will compare CBT-DAY versus treatment-as-usual (TAU) to see if CBT-DAY results in greater improvements in depressive symptoms and related outcomes.\n\nParticipants will:\n\n* Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews)\n* Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual\n* Participate in therapy sessions during the 12-week intervention period\n* Complete follow-up assessments three months after treatment to evaluate longer-term outcomes",[79,80,81],"Autism Spectrum Disorder","Depressive Disorder","Anxiety Disorders",[83,84,85,86,87],"depression","autism","youth","anxiety","cognitive behavioral therapy","NOT_YET_RECRUITING","2026-08-05",{"date":91,"type":92},"2026-08-10","ACTUAL",{"date":94,"type":73},"2026-12-01",{"date":96,"type":73},"2029-12-01",{"name":5,"class":6},1]