Depression Clinical Trial
Official title:
Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
Verified date | June 2024 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.
Status | Active, not recruiting |
Enrollment | 112 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: - Child is between the ages of 12-17 at consent/assent. - 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). - 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). - Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview - One parent/guardian is able and willing to participate. - The parent/guardian is 18 years or older. - Both parent and child can read and/or understand English. - Both parent and child reside in Texas. Exclusion Criteria: - The child has a diagnosis of psychotic disorder and/or conduct disorder. - The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care. - The child has limited verbal communication abilities. - The child is receiving concurrent psychotherapy for anxiety/depression. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor Psychiatry Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Texas Higher Education Coordinating Board |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Revised Children's Anxiety and Depression Scale - Parent-Report | 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. | 7 days | |
Primary | Clinical Global Impression - Improvement | Clinician-rated child internalizing symptom improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved). | 7 days | |
Primary | Clinical Global Impression - Severity of Illness | Clinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms). | 7 days | |
Secondary | Revised Children's Anxiety and Depression Scale - Self-Report | 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. | 7 days | |
Secondary | Pediatric Anxiety Rating Scale modified for Autism | 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. | 7 days | |
Secondary | Children's Depression Rating Scale, Revised | 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. | 7 days |
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