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Treatment of Anxiety in Late Adolescents With Autism (TALAA Trial)

N/A
Waitlist Available
Led By Adam Lewin, Ph.D.
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 16 weeks of treatment

Summary

Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety disorders affect many higher-functioning adolescents and young adults with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders among typically developing late adolescents, and work by the investigative team supports its utility in children with ASD and comorbid anxiety, very few evidence-based treatment approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the investigators are proposing to develop a CBT protocol for clinical anxiety that is personalized to the unique clinical characteristics of late adolescents (ages 16-21 years) with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 16 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 16 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety
Secondary study objectives
Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cognitive-Behavior TherapyExperimental Treatment1 Intervention
This consists of 16 weekly sessions up to 90 minutes each that helps the participant learn to cope with anxiety by facing fears, thinking more logically, and calming oneself.
Group II: Treatment as UsualPlacebo Group1 Intervention
Participants randomized to this condition will wait for a period of 16 weeks before receiving treatment in the context of the study. During this time, youth may receive psychotherapy and/or initiate or change current psychiatric medication (if applicable).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive-Behavior Therapy
2008
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
427 Previous Clinical Trials
192,587 Total Patients Enrolled
13 Trials studying Autism Spectrum Disorder
1,583 Patients Enrolled for Autism Spectrum Disorder
Johns Hopkins All Children's HospitalOTHER
45 Previous Clinical Trials
5,008,392 Total Patients Enrolled
Adam Lewin, Ph.D.Principal InvestigatorUniversity of South Florida
1 Previous Clinical Trials
30 Total Patients Enrolled
~5 spots leftby Dec 2025