Treatment of Anxiety in Late Adolescents With Autism

Autism Spectrum Disorder Clinical Trial

— TALAA  

Official title:

Treatment of Anxiety in Late Adolescents With Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977962
• Other study ID #: USF-ACH 001
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2021

Study information

• Verified date: April 2020
• Source: University of South Florida
• Contact: Adam B Lewin, Ph.D.
• Phone: 7277678230
• Email: alewin[@]health.usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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). Initial TALAA development efforts will focus on adapting relevant treatment elements from an efficacious CBT program for early adolescents with ASD and comorbid anxiety to the characteristics and clinical needs of the age group. Developmentally appropriate, novel treatment components will be added, including those focusing on fostering successful transitions to adulthood (e.g., work readiness). In response to the NIH Roadmap Initiative, attention will be paid to protocol adaptability with varying clinical presentations. Measures of treatment integrity and competence will be developed. Thereafter, protocol and measure development will be refined through our experiences treating 8 young adults (ages 16-21 years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and expert feedback. The feasibility of implementing TALAA will then be examined in the context of a pilot study incorporating all the features of the planned future efficacy trial comparing TALAA to treatment as usual, but with a limited sample size (N=44).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• 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).

Other:
• 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.

Locations

Country	Name	City	State
United States	Rothman Center for Neuropsychiatry, University of South Florida	Saint Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Johns Hopkins All Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment.	This measure is administered by a clinician and assesses anxiety with scores between 0-30. Higher ratings correspond to more severe anxiety symptoms.	After 16 weeks of treatment
Secondary	Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.	This measure is completed by the clinician and assesses the severity of anxiety on a 7 point scale (0-6; higher scores correspond to worse anxiety).	After 16 weeks of treatment