NCT06537128 Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
| NCT ID | NCT06537128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 139 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 139 participants in total. It began in 2024-11-01 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.
Eligibility Criteria
Inclusion Criteria: 1. The child is between the age of 11-17 years old at enrollment. 2. 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.). 3. 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)). 4. Anxiety disorder is the child's primary/co-primary psychiatric diagnosis, and if secondary psychopathology is present, it will not interfere with treatment. 5. 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). 6. The child is able to communicate verbally. 7. Participants are located in Texas. 8. 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 Criteria: 1. The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder. 2. The child has significant, current suicidal/homicidal ideation and/or self-injury requiring medical intervention. 3. The child has limited verbal communication abilities (e.g., no independent verbal communication), 4. The child is receiving concurrent psychotherapy (including certain forms of social skills training, or behavioral interventions that target anxiety such as applied behavioral analysis). 5. The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy. 6. The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy. 7. The child requires a higher level than can be provided through the study (e.g., significant, current suicidal ideation)
Contact & Investigator
Eric Storch, PhD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT06537128 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06537128 currently recruiting?
Yes, NCT06537128 is actively recruiting participants. Contact the research team at callie.murphy@bcm.edu for enrollment information.
Where is the NCT06537128 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06537128 clinical trial?
NCT06537128 is sponsored by Baylor College of Medicine. The principal investigator is Eric Storch, PhD at Baylor College of Medicine. The trial plans to enroll 139 participants.