Recruiting

Anxiety Treatment

Sponsor:

University of South Florida

Code:

NCT02977962

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 16 - 21

Healthy Volunteers: Accepted

Interventions

Cognitive-Behavior Therapy

Treatment as Usual

Study Details

Brief 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).

Conditions

Autism Spectrum Disorder

Study ID

NCT02977962

Start date

Jan, 2017

Status verified date

Apr, 2020

Completion date

Aug, 2021

Anticipated

Primary completion date

Apr, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 21

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Outpatient males and females with ASD between the ages 16-21 years at consent/assent.
  • The individual meets criteria for ASD.
  • The individual meets criteria for clinically significant anxiety symptoms.
  • Meets criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), specific phobia, panic disorder (PD), generalized anxiety disorder (GAD), social phobia (SP), or obsessive compulsive disorder (OCD) and has a minimum score of 14 on the Hamilton Anxiety Scale.
  • Person has a Full Scale IQ approximation > 70 as assessed by the Wechsler Abbreviated Scale for Intelligence-II two or four sub-test form.

Exclusion Criteria:

  • Receiving concurrent psychotherapy focused on anxiety.
  • Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects).
  • (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
  • Lifetime bipolar disorder, schizophrenia or schizoaffective disorder, or substance abuse in past 6 months.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive-Behavior Therapy

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.

placebo comparator: Treatment as Usual

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).

Interventions

Cognitive-Behavior Therapy

This therapy has been designed for adolescents with high functioning ASD and involves 16 weekly session where the participant learns coping skills related to addressing anxiety (e.g., exposure therapy, cognitive therapy, social skills training).

Treatment as Usual

Those who choose to participate will be enrolled in the 16 week study. They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 16). Those in this group will not receive the Cognitive-Behavior Therapy, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.

Primary outcome measure

  • Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment. [ Time Frame: After 16 weeks of treatment ]

Central Contacts and Locations

Central contacts

Adam B Lewin, Ph.D.

7277678230alewin@health.usf.edu

Locations

Rothman Center for Neuropsychiatry, University of South Florida

Recruiting

Saint Petersburg, Florida, United States, 33701

Contacts

Adam B Lewin, Ph.D.

727-767-8230alewin@health.usf.edu

Jane Mutch, Ph.D.

727-767-8230pmutch@health.usf.edu

Principal Investigator:

Adam B Lewin, Ph.D.

More Information

Sponsor

University of South Florida

Last update posted

Apr 24, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of South Florida on 2020-04-24.