Online therapy for autistic teens with anxiety
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety: Development and Evaluation of Learning to Understand and Navigate Anxiety-Adolescent
This study is testing an online therapy program for autistic teens aged 11-17 who have anxiety to see if it helps them feel better and is easier to access than traditional therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06537128 on ClinicalTrials.gov |
What this trial studies
This project aims to provide internet-delivered cognitive-behavioral therapy (iCBT) to adolescents aged 11-17 diagnosed with autism and experiencing anxiety. The approach addresses the barriers to accessing traditional in-person therapy, such as cost and availability of trained providers, particularly in rural areas. The intervention, known as LUNA-Adolescent, is designed to be accessible for both English and Spanish-speaking families, ensuring inclusivity. Previous work has shown promising results, with over 60% of participants responding positively to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-17 with a diagnosis of autism and clinically significant anxiety.
Not a fit: Patients without a diagnosis of autism or those not experiencing clinically significant anxiety may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve access to effective treatment for autistic adolescents suffering from anxiety.
How similar studies have performed: Previous studies of internet-delivered cognitive-behavioral therapy for typically-developing youth have shown moderate to strong effectiveness, suggesting potential for success in this novel application for autistic adolescents.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Eric Storch, PhD — Baylor College of Medicine
- Study coordinator: Callie Murphy, B.A.
- Email: callie.murphy@bcm.edu
- Phone: 713-798-6114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.