Status:
RECRUITING
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Lead Sponsor:
Baylor College of Medicine
Conditions:
Autism Spectrum Disorder
Autism
Eligibility:
All Genders
11-17 years
Phase:
NA
Brief Summary
Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot a...
Detailed Description
Autism affects 2-3% of youth, approximately half of whom experience a co-occurring anxiety disorder. Anxiety disorders in autistic youth are associated with significant life impairment and worsening t...
Eligibility Criteria
Inclusion
- The child is between the age of 11-17 years old at enrollment.
- The child is diagnosed with autism using a validated assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Childhood Autism Rating Scale-Second Edition (CARS-2), etc.).
- The child has current, clinically significant anxiety and/or OCD as indicated by a clinician-administered standardized assessment (e.g. Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) and Pediatric Rating Anxiety Scale modified for autism (PARS-ASD)).
- Anxiety disorder is the child's primary/co-primary psychiatric diagnosis, and if secondary psychopathology is present, it will not interfere with treatment.
- One parent/guardian over the age of 18 is able and willing to participate in assessment and treatment (e.g. has sufficient English/Spanish fluency, the decisional capacity to participate, and can commit to treatment duration).
- The child is able to communicate verbally.
- Participants are located in Texas.
- The participant has an IQ above 69, based on the Kaufman Brief Intelligence Test-Second Edition (KBIT-2), another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team)
Exclusion
- The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
- The child has significant, current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
- The child has limited verbal communication abilities (e.g., no independent verbal communication),
- The child is receiving concurrent psychotherapy (including certain forms of social skills training, or behavioral interventions that target anxiety such as applied behavioral analysis).
- The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
- The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
- The child requires a higher level than can be provided through the study (e.g., significant, current suicidal ideation)
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT06537128
Start Date
November 1 2024
End Date
April 1 2026
Last Update
July 23 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030