<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977962</url>
  </required_header>
  <id_info>
    <org_study_id>USF-ACH 001</org_study_id>
    <nct_id>NCT02977962</nct_id>
  </id_info>
  <brief_title>Treatment of Anxiety in Late Adolescents With Autism</brief_title>
  <acronym>TALAA</acronym>
  <official_title>Treatment of Anxiety in Late Adolescents With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins All Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young&#xD;
      adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety&#xD;
      disorders affect many higher-functioning adolescents and young adults with ASD, causing&#xD;
      substantial distress and impairment over and above that caused by an ASD diagnosis alone.&#xD;
      While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders&#xD;
      among typically developing late adolescents, and work by the investigative team supports its&#xD;
      utility in children with ASD and comorbid anxiety, very few evidence-based treatment&#xD;
      approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the&#xD;
      investigators are proposing to develop a CBT protocol for clinical anxiety that is&#xD;
      personalized to the unique clinical characteristics of late adolescents (ages 16-21 years)&#xD;
      with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young&#xD;
      adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety&#xD;
      disorders affect many higher-functioning adolescents and young adults with ASD, causing&#xD;
      substantial distress and impairment over and above that caused by an ASD diagnosis alone.&#xD;
      While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders&#xD;
      among typically developing late adolescents, and work by the investigative team supports its&#xD;
      utility in children with ASD and comorbid anxiety, very few evidence-based treatment&#xD;
      approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the&#xD;
      investigators are proposing to develop a CBT protocol for clinical anxiety that is&#xD;
      personalized to the unique clinical characteristics of late adolescents (ages 16-21 years)&#xD;
      with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA). Initial&#xD;
      TALAA development efforts will focus on adapting relevant treatment elements from an&#xD;
      efficacious CBT program for early adolescents with ASD and comorbid anxiety to the&#xD;
      characteristics and clinical needs of the age group. Developmentally appropriate, novel&#xD;
      treatment components will be added, including those focusing on fostering successful&#xD;
      transitions to adulthood (e.g., work readiness). In response to the NIH Roadmap Initiative,&#xD;
      attention will be paid to protocol adaptability with varying clinical presentations. Measures&#xD;
      of treatment integrity and competence will be developed. Thereafter, protocol and measure&#xD;
      development will be refined through our experiences treating 8 young adults (ages 16-21&#xD;
      years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and&#xD;
      expert feedback. The feasibility of implementing TALAA will then be examined in the context&#xD;
      of a pilot study incorporating all the features of the planned future efficacy trial&#xD;
      comparing TALAA to treatment as usual, but with a limited sample size (N=44).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment.</measure>
    <time_frame>After 16 weeks of treatment</time_frame>
    <description>This measure is administered by a clinician and assesses anxiety with scores between 0-30. Higher ratings correspond to more severe anxiety symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.</measure>
    <time_frame>After 16 weeks of treatment</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive-Behavior Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavior Therapy</intervention_name>
    <description>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).</description>
    <arm_group_label>Cognitive-Behavior Therapy</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>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.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatient males and females with ASD between the ages 16-21 years at consent/assent.&#xD;
&#xD;
          -  The individual meets criteria for ASD.&#xD;
&#xD;
          -  The individual meets criteria for clinically significant anxiety symptoms.&#xD;
&#xD;
          -  Meets criteria for a diagnosis of one of the following anxiety disorders: separation&#xD;
             anxiety disorder (SAD), specific phobia, panic disorder (PD), generalized anxiety&#xD;
             disorder (GAD), social phobia (SP), or obsessive compulsive disorder (OCD) and has a&#xD;
             minimum score of 14 on the Hamilton Anxiety Scale.&#xD;
&#xD;
          -  Person has a Full Scale IQ approximation &gt; 70 as assessed by the Wechsler Abbreviated&#xD;
             Scale for Intelligence-II two or four sub-test form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving concurrent psychotherapy focused on anxiety.&#xD;
&#xD;
          -  Initiation of an antidepressant medication within 12 weeks before study enrollment or&#xD;
             an antipsychotic medication 6 weeks before study enrollment or the child has changed&#xD;
             the dose of an established medication within 8 weeks before study enrollment (4 weeks&#xD;
             for antipsychotic) or during psychotherapy (unless the dose is lowered because of side&#xD;
             effects).&#xD;
&#xD;
          -  (a) Current clinically significant suicidality or (b) individuals who have engaged in&#xD;
             suicidal behaviors within 6 months will be excluded and referred for appropriate&#xD;
             clinical intervention.&#xD;
&#xD;
          -  Lifetime bipolar disorder, schizophrenia or schizoaffective disorder, or substance&#xD;
             abuse in past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Lewin, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adam B Lewin, Ph.D.</last_name>
    <phone>7277678230</phone>
    <email>alewin@health.usf.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rothman Center for Neuropsychiatry, University of South Florida</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adam B Lewin, Ph.D.</last_name>
      <phone>727-767-8230</phone>
      <email>alewin@health.usf.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jane Mutch, Ph.D.</last_name>
      <phone>727-767-8230</phone>
      <email>pmutch@health.usf.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jane Mutch, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adam B Lewin, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tanya K Murphy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977962
org study id: USF-ACH 001
nct id: NCT02977962
lead sponsor: 
collaborator: 
has dmc: No
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).
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).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment.
time frame: After 16 weeks of treatment
description: This measure is administered by a clinician and assesses anxiety with scores between 0-30. Higher ratings correspond to more severe anxiety symptoms.
measure: Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment.
time frame: After 16 weeks of treatment
description: 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).
arm group label: Cognitive-Behavior Therapy
arm group type: Experimental
description: 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.
arm group label: Treatment as Usual
arm group type: Placebo Comparator
description: 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).
intervention type: Behavioral
intervention name: Cognitive-Behavior Therapy
description: 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).
arm group label: Cognitive-Behavior Therapy
other name: CBT
intervention type: Other
intervention name: Treatment as Usual
description: 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.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 16 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adam Lewin, Ph.D.
role: Principal Investigator
affiliation: University of South Florida
last name: Adam B Lewin, Ph.D.
phone: 7277678230
email: alewin@health.usf.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No