Autism Spectrum Disorder Clinical Trial
Official title:
Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD
Verified date | December 2023 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study compares the effectiveness of two levels of therapist support for an internet-based, parent-led cognitive behavioral therapy for youth with anxiety and ASD.
Status | Completed |
Enrollment | 114 |
Est. completion date | December 17, 2023 |
Est. primary completion date | August 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 15 Years |
Eligibility | Inclusion Criteria: - Child is between the ages 7-15 years at consent/assent. - The child meets criteria for ASD. - The child meets criteria for an anxiety and/or obsessive compulsive disorder (OCD) as determined by the Mini Neuropsychiatric Interview for Children and Adolescents - Anxiety and/or OCD is the primary presenting problem as determined by the Mini Neuropsychiatric Interview for Children and Adolescents - One parent/guardian is able and willing to participate. - The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70. - The child is able to communicate verbally. - Participants must reside in Texas and must be in the state of Texas when taking calls. Exclusion Criteria: - The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability. - The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention. - The child is receiving concurrent psychotherapy for anxiety. - Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder | Clinician rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30. | 7 days | |
Primary | Clinical Global Impression-Improvement | Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved). | 7 days | |
Secondary | Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale | Parent rated child anxiety severity. It is a 37-item scale and each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 to 111. | 7 days | |
Secondary | Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale | Child rated anxiety severity. It is a 37-item scale and each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 to 111. | 7 days | |
Secondary | Social Responsiveness Scale, Second Edition | Parent rated child impairment in social behaviors. It is a 65-item scale and each item is scored on a 1 ("not true") to 4 ("almost always true") scale (higher scores correspond to greater impairment), yielding a total raw score between 65 and 260. | 7 days | |
Secondary | Sheehan Disability Scale | Parent rated child functional impairment. It is a 5-item scale and each item is scored on a 0 ("not at all") to 10 ("extremely") scale (higher scores correspond to greater impairment), yielding a total between 0 and 50. | 7 days |
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