Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT05738967
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2023-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Revised Children's Anxiety and Depression Scale - Parent-Report", 'timeFrame': '7 days', 'description': 'Parent-rated child anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.'}, {'measure': 'Clinical Global Impression - Improvement', 'timeFrame': '7 days', 'description': 'Clinician-rated child internalizing symptom improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).'}, {'measure': 'Clinical Global Impression - Severity of Illness', 'timeFrame': '7 days', 'description': 'Clinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms).'}], 'secondaryOutcomes': [{'measure': "Revised Children's Anxiety and Depression Scale - Self-Report", 'timeFrame': '7 days', 'description': 'Child rated anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.'}, {'measure': 'Pediatric Anxiety Rating Scale modified for Autism', 'timeFrame': '7 days', 'description': 'Clinician-rated child anxiety severity. The rating scale first includes a checklist of common anxiety symptoms that are rated as present/absent and is followed by a severity rating scale with five Likert scale items. Each severity item is scored on a 0 to 5 scale, (higher scores correspond to greater severity), yielding a total between 0 and 30.'}, {'measure': "Children's Depression Rating Scale, Revised", 'timeFrame': '7 days', 'description': 'Clinician-rated child depression severity. It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (higher scores correspond to greater severity), yielding a total between 17 and 113.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive behavioral therapy', 'CBT', 'exposure therapy', 'behavioral activation'], 'conditions': ['Anxiety', 'Depression', 'Emotional Disorder', 'Autism']}, 'referencesModule': {'references': [{'pmid': '28423145', 'type': 'BACKGROUND', 'citation': 'Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.'}, {'pmid': '21735077', 'type': 'BACKGROUND', 'citation': 'van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.'}, {'pmid': '29497980', 'type': 'BACKGROUND', 'citation': 'Hudson CC, Hall L, Harkness KL. Prevalence of Depressive Disorders in Individuals with Autism Spectrum Disorder: a Meta-Analysis. J Abnorm Child Psychol. 2019 Jan;47(1):165-175. doi: 10.1007/s10802-018-0402-1.'}, {'pmid': '26655958', 'type': 'BACKGROUND', 'citation': 'Chu BC, Crocco ST, Esseling P, Areizaga MJ, Lindner AM, Skriner LC. Transdiagnostic group behavioral activation and exposure therapy for youth anxiety and depression: Initial randomized controlled trial. Behav Res Ther. 2016 Jan;76:65-75. doi: 10.1016/j.brat.2015.11.005. Epub 2015 Nov 19.'}, {'pmid': '31190198', 'type': 'BACKGROUND', 'citation': 'Uljarevic M, Hedley D, Rose-Foley K, Magiati I, Cai RY, Dissanayake C, Richdale A, Trollor J. Anxiety and Depression from Adolescence to Old Age in Autism Spectrum Disorder. J Autism Dev Disord. 2020 Sep;50(9):3155-3165. doi: 10.1007/s10803-019-04084-z.'}, {'pmid': '31755906', 'type': 'BACKGROUND', 'citation': 'Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.'}]}, 'descriptionModule': {'briefSummary': 'This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.', 'detailedDescription': 'About 1 in 54 adolescents are estimated to be on the autism spectrum, with over half suffering from anxiety or depressive disorders. These disorders contribute to suicidality, family stress, social impairments, and difficulties transitioning to adulthood among autistic youth. Given the frequency of anxiety and depressive disorders among autistic adolescents and the increased risk of impairment, developing effective treatments for anxiety and depression tailored to this population is a top priority.\n\nTransdiagnostic cognitive behavioral therapy (CBT) for other populations, including typically developing adolescents, may confer broader benefits than disorder-specific CBT and facilitate broader dissemination and implementation. However, there has been little research conducted on transdiagnostic treatments among autistic adolescents. Thus, this study proposes to address this gap by testing transdiagnostic CBT for autistic adolescents with anxiety and depression.\n\nThe study involves two phases: 1) a pilot intervention; and 2) a randomized controlled trial.\n\nThe pilot intervention will involve 12 adolescent-caregiver dyads to further refine the treatment model and its assessment measures. The randomized trial will involve 100 adolescent-caregiver dyads to further evaluate the clinical efficacy of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child is between the ages of 12-17 at consent/assent.\n* The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition).\n* The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\\>11) and/or the Children's Depression Rating Scale-Revised (\\>39).\n* Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview\n* One parent/guardian is able and willing to participate.\n* The parent/guardian is 18 years or older.\n* Both parent and child can read and/or understand English.\n* Both parent and child reside in Texas.\n\nExclusion Criteria:\n\n* The child has a diagnosis of psychotic disorder and/or conduct disorder.\n* The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care.\n* The child has limited verbal communication abilities.\n* The child is receiving concurrent psychotherapy for anxiety/depression.\n* The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy."}, 'identificationModule': {'nctId': 'NCT05738967', 'briefTitle': 'Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents', 'orgStudyIdInfo': {'id': 'H-52639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transdiagnostic cognitive behavioral therapy', 'interventionNames': ['Behavioral: Transdiagnostic cognitive behavioral therapy (CBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Transdiagnostic cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Adolescent-caregiver dyads will will participate in CBT focused on exposure therapy and behavioral activation. It will also include flexible incorporation of emotion-focused coping and adaptations for autism.', 'armGroupLabels': ['Transdiagnostic cognitive behavioral therapy']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'otherNames': ['TAU'], 'description': 'Adolescent-caregiver dyads will participate in coordinated referrals to the community. They may receive psychotherapy and/or initiate or change current psychiatric medication (if applicable).', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Psychiatry Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available once the primary results are published in a peer-reviewed journal', 'ipdSharing': 'YES', 'description': 'We plan on publishing the study description, protocol/procedures, and raw data on an OSF website once primary results are published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Texas Higher Education Coordinating Board', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eric A Storch', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}