<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/NCT03279471</url>
  </required_header>
  <id_info>
    <org_study_id>1097281</org_study_id>
    <nct_id>NCT03279471</nct_id>
  </id_info>
  <brief_title>Specifying and Treating Anxiety in Autism Research</brief_title>
  <acronym>STAAR</acronym>
  <official_title>Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study&#xD;
      aims to better characterize the sub-group of children and preadolescents with ASD that&#xD;
      exhibit clinically significant anxiety by conducting a 16-week randomized comparative&#xD;
      treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA),&#xD;
      the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study&#xD;
      involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab&#xD;
      visits for safety testing, and 1-2 optional fMRI visits. The study provides 16-weeks of&#xD;
      anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or&#xD;
      medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study&#xD;
      completion a 3 month follow up call is conducted and participants in the placebo group are&#xD;
      given the option to participate in an additional study phase with the study treatment of&#xD;
      their choice. Study participation can be done remotely through the use of telehealth and&#xD;
      local labs, visits to the UC Davis MIND Institute are not required for most participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit&#xD;
      clinically significant anxiety symptoms. These symptoms are associated with increased social&#xD;
      deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children&#xD;
      and adolescents with anxiety also frequently avoid potentially stressful situations, thereby&#xD;
      missing opportunities to learn important new skills. Despite the significant consequences of&#xD;
      anxiety symptoms, several critical treatment-relevant issues remain unresolved. First, there&#xD;
      is a lack of clarity about how to differentiate ASD and anxiety symptoms. Second, little is&#xD;
      known about how anxiety manifests in those with ASD and intellectual disability (ID). Third,&#xD;
      the neural substrates of anxiety in ASD are poorly understood. The overarching goal of this&#xD;
      project is to investigate these open issues in order to make interventions more precise, more&#xD;
      personalized, and more likely to promote positive outcomes -- an objective consistent with&#xD;
      the National Institutes of Health (NIH), the Roadmap, Precision Medicine, and Research Domain&#xD;
      Criteria Project (RDoC) Initiatives and the Interagency Autism Coordinating Committee (IACC)&#xD;
      Strategic Plan, Chapter 4.&#xD;
&#xD;
      While there is no doubt that anxiety is a very serious issue for those with ASD, what to do&#xD;
      about this problem is less clear. The search for empirically-validated treatments has begun&#xD;
      with multiple small trials providing promising evidence that selective serotonin reuptake&#xD;
      inhibitors (SSRIs) and cognitive behavior therapy (CBT) might reduce anxiety in those with&#xD;
      ASD. However, this work is in its early stages. There is a great need for large, rigorously&#xD;
      designed trials that validate the effectiveness of both medication and CBT, as well as&#xD;
      functional neuroimaging studies that identify neural predictors of treatment efficacy and&#xD;
      markers of therapy-induced change. Such work holds the potential to help answer the questions&#xD;
      posed above and to assist the field in developing more personalized treatments. In Project 1&#xD;
      of the Center for the Development of Phenotype-Based Treatments of Autism Spectrum Disorder,&#xD;
      we will conduct a study in children with ASD and clinically significant anxiety ages 8-14 to&#xD;
      compare efficacy of these different treatment types.&#xD;
&#xD;
      The overall aims of the study are to better characterize the sub-group of children and&#xD;
      preadolescents with ASD that exhibit clinically significant anxiety and fears through a&#xD;
      16-week randomized comparative treatment trial of Behavioral Intervention for Anxiety in&#xD;
      Children with Autism (BIACA), sertraline, and placebo in youth with ASD, IQ&gt;50, and&#xD;
      clinically significant anxiety as assessed by a PARS score that is greater than or equal to&#xD;
      8. Clinician-administered gold standard assays will be used of traditional DSM (Pediatric&#xD;
      Anxiety Rating Scale [PARS] and the Anxiety Disorders Interview Schedule-IV [ADIS-IV]), and&#xD;
      nontraditional ASD related anxiety symptoms (Autism Spectrum Addendum to the ADIS [ASDD]), as&#xD;
      well as parent reports of potentially overlapping symptoms that complicate the ASD anxiety&#xD;
      phenotype. Additionally fMRI will be used to investigate neural predictors of treatment&#xD;
      efficacy, markers of treatment induced change, and signatures of anxiety sub-types.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>3 Arm trial comparing manualized CBT/social skills training versus sertraline versus pill placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>participants do not know what interventions others receive; med arm care providers don't know what interventions their patients receive; assessors don't know what treatments the participants they asses receive</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pediatric Anxiety Rating Scale</measure>
    <time_frame>Change from 1 Weeks (pre-treatment) to 17 Weeks (treatment completion), and 29 Weeks (3 month post-treatment follow-up)</time_frame>
    <description>The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The PARS will be used to assess both immediately pre- and post-treatment anxiety, as well as at a 3 month post-treatment follow-up.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>CBT/BIACA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sertraline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These participants will receive sertraline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pill Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>These individuals will receive a pill placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sertraline</intervention_name>
    <description>Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.</description>
    <arm_group_label>Sertraline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT/BIACA</intervention_name>
    <description>Participants receive 16 weeks of BIACA therapy.</description>
    <arm_group_label>CBT/BIACA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.</description>
    <arm_group_label>Pill Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Outpatient boys and girls with ASD between ages 8-14 years at consent.&#xD;
&#xD;
          2. Meets criteria for a diagnosis of ASD.&#xD;
&#xD;
          3. Meets criteria for clinically significant anxiety symptoms as defined by a minimum&#xD;
             score of 8 on the PARS Severity Scale.&#xD;
&#xD;
          4. Meets criteria for clinically significant anxiety symptoms as defined by qualifying&#xD;
             for diagnosis on 1 or more non-phobia items on the ADIS.&#xD;
&#xD;
          5. The child has a Verbal Comprehension IQ greater than 50 as assessed on the Wechsler&#xD;
             Abbreviated Scales of Intelligence or other standardized cognitive measure.&#xD;
&#xD;
          6. Anxiety symptoms are considered the primary mental health problem (i.e., most&#xD;
             impairing/distressing)&#xD;
&#xD;
          7. Stable medication regimen for 8 weeks prior to screening visit, including alternative&#xD;
             medication, nutritionals, or therapeutic diets.&#xD;
&#xD;
          8. Stable non-psychotherapy regimen for 4 weeks prior to screening visits.&#xD;
             Non-psychotherapy regimen may include:&#xD;
&#xD;
               1. Academic tutoring&#xD;
&#xD;
               2. Occupational therapy&#xD;
&#xD;
               3. Speech therapy&#xD;
&#xD;
               4. School aides&#xD;
&#xD;
          9. Stable psychosocial treatment regimen for 4 weeks prior to screening visits. Allowed&#xD;
             psychosocial treatments may include:&#xD;
&#xD;
               1. School counseling (no more than 60 minutes per week in duration)&#xD;
&#xD;
               2. Psychotherapy&#xD;
&#xD;
               3. Social skills training&#xD;
&#xD;
               4. Applied behavior analysis (ABA) (up to 10 hours per week)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Subject is receiving significant concurrent psychosocial treatment with the primary&#xD;
             aim to treat the child's anxiety.&#xD;
&#xD;
             a. Families will have the option of discontinuing such services to enroll in the&#xD;
             study. If a potential participant is receiving non-allowed treatments at the time of&#xD;
             the phone evaluation and wishes to discontinue these treatments to enter the study,&#xD;
             the patient will be asked to discuss this option with their clinician to determine&#xD;
             whether termination would be safe and in the child's best interest. We will not&#xD;
             influence the decision patients make with their clinician.&#xD;
&#xD;
          2. History of intolerance to sertraline OR previous unsuccessful treatment with&#xD;
             sertraline or other SSRIs judged adequate in dose (per list below) and taken for at&#xD;
             least 6 weeks, within the past 12 months.&#xD;
&#xD;
               1. Sertraline - 100mg/daily&#xD;
&#xD;
               2. Citalopram or paroxetine - 30mg/daily&#xD;
&#xD;
               3. Escitalopram - 20mg/daily&#xD;
&#xD;
               4. Fluoxetine - 20mg/daily&#xD;
&#xD;
               5. Fluvoxamine - 100mg/daily&#xD;
&#xD;
          3. Current clinically significant suicidal behaviors with intent or plan or individuals&#xD;
             who have engaged in suicidal behaviors within 6 months. Study physicians will direct&#xD;
             patient to appropriate clinical care if these behaviors are seen.&#xD;
&#xD;
          4. Child has unsuccessful treatment for anxiety using a manualized CBT program within the&#xD;
             previous 2 years (at least 10 sessions over a period of less than 1 year conducted by&#xD;
             a licensed provider of CBT). This will be determined through parent report, records&#xD;
             review and speaking with the clinician if appropriate.&#xD;
&#xD;
          5. Lifetime DSM-5 bipolar disorder, schizophrenia or schizoaffective disorder as assessed&#xD;
             by all forms of information (i.e., clinical history, data from the ADIS-IV, etc.).&#xD;
&#xD;
          6. Abnormal laboratory or electrocardiogram results at screening that are in the opinion&#xD;
             of the investigator clinically significant and may jeopardize the safety of the study&#xD;
             subject.&#xD;
&#xD;
          7. Child has a major neurological disorder or medical illness that requires a prohibited&#xD;
             episodic or chronic systemic medication that might interfere with the absorption,&#xD;
             distribution, metabolism, or excretion of the study medication places the subject at&#xD;
             increased risk, or that would interfere with study participation (e.g., frequent&#xD;
             hospitalizations, frequent school absences).&#xD;
&#xD;
          8. Child pregnancy as indicated by history or positive pregnancy test.&#xD;
&#xD;
          9. Inability to safely swallow study medication after pill swallowing education.&#xD;
&#xD;
         10. Child and parent/caregiver who do not speak English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marjorie Solomon, PH.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis MIND Institute</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/study-of-anxiety-treatments-in-autism-spectrum-disorder-asd-745682/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <reference>
    <citation>Leyfer OT, Folstein SE, Bacalman S, Davis NO, Dinh E, Morgan J, Tager-Flusberg H, Lainhart JE. Comorbid psychiatric disorders in children with autism: interview development and rates of disorders. J Autism Dev Disord. 2006 Oct;36(7):849-61. doi: 10.1007/s10803-006-0123-0.</citation>
    <PMID>16845581</PMID>
  </reference>
  <reference>
    <citation>Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.</citation>
    <PMID>18645422</PMID>
  </reference>
  <reference>
    <citation>van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.</citation>
    <PMID>21735077</PMID>
  </reference>
  <reference>
    <citation>White SW, Oswald D, Ollendick T, Scahill L. Anxiety in children and adolescents with autism spectrum disorders. Clin Psychol Rev. 2009 Apr;29(3):216-29. doi: 10.1016/j.cpr.2009.01.003. Epub 2009 Jan 25.</citation>
    <PMID>19223098</PMID>
  </reference>
  <reference>
    <citation>Bishop-Fitzpatrick L, Mazefsky CA, Minshew NJ, Eack SM. The relationship between stress and social functioning in adults with autism spectrum disorder and without intellectual disability. Autism Res. 2015 Apr;8(2):164-73. doi: 10.1002/aur.1433. Epub 2014 Dec 19.</citation>
    <PMID>25524571</PMID>
  </reference>
  <reference>
    <citation>Gillott A, Furniss F, Walter A. Anxiety in high-functioning children with autism. Autism. 2001 Sep;5(3):277-86. doi: 10.1177/1362361301005003005.</citation>
    <PMID>11708587</PMID>
  </reference>
  <reference>
    <citation>Craske MG, Stein MB. Anxiety. Lancet. 2016 Dec 17;388(10063):3048-3059. doi: 10.1016/S0140-6736(16)30381-6. Epub 2016 Jun 24.</citation>
    <PMID>27349358</PMID>
  </reference>
  <reference>
    <citation>Vasa RA, Mazurek MO. An update on anxiety in youth with autism spectrum disorders. Curr Opin Psychiatry. 2015 Mar;28(2):83-90. doi: 10.1097/YCO.0000000000000133.</citation>
    <PMID>25602249</PMID>
  </reference>
  <reference>
    <citation>Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28.</citation>
    <PMID>24167175</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>autism spectrum disorder</keyword>
  <keyword>anxiety</keyword>
  <keyword>cognitive behavior therapy</keyword>
  <keyword>functional neuroimaging</keyword>
  <keyword>STAAR</keyword>
  <keyword>ASD</keyword>
  <keyword>MIND Institute</keyword>
  <keyword>UC Davis</keyword>
  <keyword>MIND</keyword>
  <keyword>UCD</keyword>
  <keyword>autism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sertraline</mesh_term>
  </intervention_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/NCT03279471
org study id: 1097281
nct id: NCT03279471
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The Specifying and Treating the Anxiety Phenotype in Autism Spectrum Disorder (STAAR) study
      aims to better characterize the sub-group of children and preadolescents with ASD that
      exhibit clinically significant anxiety by conducting a 16-week randomized comparative
      treatment trial of the Behavioral Intervention for Anxiety in Children with Autism (BIACA),
      the medication sertraline, and placebo in youth with ASD ages 8-14 years old. The study
      involves 2-3 half day telehealth visits for behavioral and medical assessments, 1-2 lab
      visits for safety testing, and 1-2 optional fMRI visits. The study provides 16-weeks of
      anxiety treatment involving weekly BIACA therapy either in-person or through telehealth, or
      medical check-up visits either at the UC Davis MIND Institute or via telehealth. After study
      completion a 3 month follow up call is conducted and participants in the placebo group are
      given the option to participate in an additional study phase with the study treatment of
      their choice. Study participation can be done remotely through the use of telehealth and
      local labs, visits to the UC Davis MIND Institute are not required for most participants.
Approximately 40%-80% of children and adolescents with autism spectrum disorder (ASD) exhibit
      clinically significant anxiety symptoms. These symptoms are associated with increased social
      deficits, depression, irritability, and stereotyped and self-injurious behaviors. Children
      and adolescents with anxiety also frequently avoid potentially stressful situations, thereby
      missing opportunities to learn important new skills. Despite the significant consequences of
      anxiety symptoms, several critical treatment-relevant issues remain unresolved. First, there
      is a lack of clarity about how to differentiate ASD and anxiety symptoms. Second, little is
      known about how anxiety manifests in those with ASD and intellectual disability (ID). Third,
      the neural substrates of anxiety in ASD are poorly understood. The overarching goal of this
      project is to investigate these open issues in order to make interventions more precise, more
      personalized, and more likely to promote positive outcomes -- an objective consistent with
      the National Institutes of Health (NIH), the Roadmap, Precision Medicine, and Research Domain
      Criteria Project (RDoC) Initiatives and the Interagency Autism Coordinating Committee (IACC)
      Strategic Plan, Chapter 4.

      While there is no doubt that anxiety is a very serious issue for those with ASD, what to do
      about this problem is less clear. The search for empirically-validated treatments has begun
      with multiple small trials providing promising evidence that selective serotonin reuptake
      inhibitors (SSRIs) and cognitive behavior therapy (CBT) might reduce anxiety in those with
      ASD. However, this work is in its early stages. There is a great need for large, rigorously
      designed trials that validate the effectiveness of both medication and CBT, as well as
      functional neuroimaging studies that identify neural predictors of treatment efficacy and
      markers of therapy-induced change. Such work holds the potential to help answer the questions
      posed above and to assist the field in developing more personalized treatments. In Project 1
      of the Center for the Development of Phenotype-Based Treatments of Autism Spectrum Disorder,
      we will conduct a study in children with ASD and clinically significant anxiety ages 8-14 to
      compare efficacy of these different treatment types.

      The overall aims of the study are to better characterize the sub-group of children and
      preadolescents with ASD that exhibit clinically significant anxiety and fears through a
      16-week randomized comparative treatment trial of Behavioral Intervention for Anxiety in
      Children with Autism (BIACA), sertraline, and placebo in youth with ASD, IQ>50, and
      clinically significant anxiety as assessed by a PARS score that is greater than or equal to
      8. Clinician-administered gold standard assays will be used of traditional DSM (Pediatric
      Anxiety Rating Scale [PARS] and the Anxiety Disorders Interview Schedule-IV [ADIS-IV]), and
      nontraditional ASD related anxiety symptoms (Autism Spectrum Addendum to the ADIS [ASDD]), as
      well as parent reports of potentially overlapping symptoms that complicate the ASD anxiety
      phenotype. Additionally fMRI will be used to investigate neural predictors of treatment
      efficacy, markers of treatment induced change, and signatures of anxiety sub-types.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 Arm trial comparing manualized CBT/social skills training versus sertraline versus pill placebo
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: participants do not know what interventions others receive; med arm care providers don't know what interventions their patients receive; assessors don't know what treatments the participants they asses receive
measure: Change in Pediatric Anxiety Rating Scale
time frame: Change from 1 Weeks (pre-treatment) to 17 Weeks (treatment completion), and 29 Weeks (3 month post-treatment follow-up)
description: The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The PARS will be used to assess both immediately pre- and post-treatment anxiety, as well as at a 3 month post-treatment follow-up.
arm group label: CBT/BIACA
arm group type: Experimental
description: These participants will receive CBT treatment using Behavioral Interventions for Anxiety in Children with Autism (BIACA). BIACA is an anxiety treatment package designed for children with ASD that includes elements of CBT and social skills training.
arm group label: Sertraline
arm group type: Active Comparator
description: These participants will receive sertraline
arm group label: Pill Placebo
arm group type: Placebo Comparator
description: These individuals will receive a pill placebo.
intervention type: Drug
intervention name: Sertraline
description: Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.
arm group label: Sertraline
intervention type: Behavioral
intervention name: CBT/BIACA
description: Participants receive 16 weeks of BIACA therapy.
arm group label: CBT/BIACA
intervention type: Drug
intervention name: Placebo
description: Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
arm group label: Pill Placebo
criteria: 
gender: All
minimum age: 8 Years
maximum age: 14 Years
healthy volunteers: No
last name: Marjorie Solomon, PH.D.
role: Principal Investigator
affiliation: UC Davis
facility: 
country: United States
url: https://studypages.com/s/study-of-anxiety-treatments-in-autism-spectrum-disorder-asd-745682/
description: Learn more or sign up for the study here!
citation: Leyfer OT, Folstein SE, Bacalman S, Davis NO, Dinh E, Morgan J, Tager-Flusberg H, Lainhart JE. Comorbid psychiatric disorders in children with autism: interview development and rates of disorders. J Autism Dev Disord. 2006 Oct;36(7):849-61. doi: 10.1007/s10803-006-0123-0.
PMID: 16845581
citation: Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. Psychiatric disorders in children with autism spectrum disorders: prevalence, comorbidity, and associated factors in a population-derived sample. J Am Acad Child Adolesc Psychiatry. 2008 Aug;47(8):921-9. doi: 10.1097/CHI.0b013e318179964f.
PMID: 18645422
citation: van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.
PMID: 21735077
citation: White SW, Oswald D, Ollendick T, Scahill L. Anxiety in children and adolescents with autism spectrum disorders. Clin Psychol Rev. 2009 Apr;29(3):216-29. doi: 10.1016/j.cpr.2009.01.003. Epub 2009 Jan 25.
PMID: 19223098
citation: Bishop-Fitzpatrick L, Mazefsky CA, Minshew NJ, Eack SM. The relationship between stress and social functioning in adults with autism spectrum disorder and without intellectual disability. Autism Res. 2015 Apr;8(2):164-73. doi: 10.1002/aur.1433. Epub 2014 Dec 19.
PMID: 25524571
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PMID: 24167175
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
mesh term: Sertraline
sharing ipd: No