Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety (NCT06537128) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
United States139 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range
11 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pediatric Anxiety Rating Scale modified for ASD (PARS-ASD)
Timeframe: Baseline (before treatment), during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
. 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
. 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)