Treatment of Anxiety in Late Adolescents With Autism

NCT02977962 | Unknown

• 1 other identifier: USF-ACH 001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.

  After 16 weeks of treatment

Study Arms (2)

Cognitive-Behavior Therapy

EXPERIMENTAL

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.

Behavioral: Cognitive-Behavior Therapy

Treatment as Usual

PLACEBO COMPARATOR

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).

Other: Treatment as Usual

Interventions

Cognitive-Behavior Therapy BEHAVIORAL

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).

Also known as: CBT

Cognitive-Behavior Therapy

Treatment as Usual OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• Johns Hopkins All Children's Hospital: collaborator

Study Sites (1)

Rothman Center for Neuropsychiatry, University of South Florida

St. Petersburg, Florida, 33701, United States

RECRUITING

Related Publications (1)

• Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2.

  PMID: 34693989 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam Lewin, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam B Lewin, Ph.D.

CONTACT

7277678230; alewin@health.usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: January 1, 2017
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)