<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/NCT04432077</url>
  </required_header>
  <id_info>
    <org_study_id>2019A06</org_study_id>
    <nct_id>NCT04432077</nct_id>
  </id_info>
  <brief_title>Anxiety Intervention for Preschool Children With ASD</brief_title>
  <official_title>Piloting an Integrated Anxiety Intervention for Preschool Children With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Organization for Autism Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment&#xD;
      program for anxiety in preschool children with autism spectrum disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population,&#xD;
      anxiety often emerges when children are very young, yet there are no evidence-based&#xD;
      treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces&#xD;
      anxiety levels in young, typically developing children and older children with ASD. This&#xD;
      study pilots the DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)&#xD;
      program, which is an integrated treatment program that utilizes CBT modified for young&#xD;
      children with ASD. The treatment includes heavy doses of parent training to reduce&#xD;
      accommodation of the child's anxiety symptoms and interventions targeting fear of&#xD;
      uncertainty, a common fear in children with ASD. The feasibility, acceptability, and&#xD;
      preliminary efficacy of this treatment program will be studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) after 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week treatment (pre-treatment to post-treatment)</time_frame>
    <description>clinician administered, semi-structured interview assessing anxiety disorders; clinical severity ratings range from 0 to 3 or 0 to 8; higher scores indicate more impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in child anxiety symptoms on Clinical Global Impressions Scale-Improvement following 12-week intervention</measure>
    <time_frame>Following 12-week intervention (post-treatment)</time_frame>
    <description>used to assess treatment response; scores range from 1 (very much improved) to 7 (very much worse)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child anxiety symptoms on the Screen for Child Anxiety Related Disorders following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>parent and teacher report scale measuring levels of anxiety in children older than 5 years old; scores range from 0 to 114; higher scores indicate higher anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in severity of anxiety and other psychiatric symptoms on Child Behavior Checklist following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>an established 99-item parent and teacher report of broad psychopathology; T scores range from 20 to 100; Syndrome scales: T-scores over 65 indicate clinically significant symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child's tolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>parent and teacher report scale measuring response to uncertainty and low environmental structure; scores range from 1 to 5; higher scores indicate higher intolerance of uncertainty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child ASD symptoms on Social Responsiveness Scale following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>parent report scale that assesses the presence and severity of social impairment in children; T-scores range from 20 to 100; higher scores indicate higher ASD severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child repetitive behaviors on Repetitive Behavior Scale-Revised following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>parent-report measure of repetitive behavior in children with ASD; scores range from 0 to 176; higher scores indicate greater impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parental anxiety and depression symptoms on Hospital Anxiety and Depression Scale following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>parental screening tool that captures clinical anxiety and depression; scores range from 0 to 21; higher scores indicate higher anxiety and/or depression symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parental tolerance of uncertainty on Intolerance of Uncertainty Scale following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week wailist (baseline to pre-treatment); Before and after 12-week intervention</time_frame>
    <description>parental scale that measures responses to uncertainty, ambiguous situations and the future; scores range from 12 to 60; higher scores indicate higher intolerance of uncertainty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on parental accommodating behaviors on Family Accommodation Scale following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child attention bias to threat on Behavioral Paradigms following 12-week waitlist and 12-week intervention</measure>
    <time_frame>Before and after 12-week waitlist (pre-treatment to post-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)</time_frame>
    <description>eye tracking paradigms used to assess attention bias to threat; more frequent saccades to threatening stimuli indicate higher attention bias to threat</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Anxiety Disorder</condition>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants receive the DINOSAUR intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)</intervention_name>
    <description>DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 4 years 0 months to 6 years 11 months&#xD;
&#xD;
          -  NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5&#xD;
&#xD;
          -  Expressive and Receptive Language scores ≥ 85 based on Preschool Language Scale -&#xD;
             Fifth Edition or Orals or Written Language Scales, Second Edition&#xD;
&#xD;
          -  DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety&#xD;
             Disorder and/or the distinct diagnosis of Other Social Fear based on the results of&#xD;
             the Anxiety Disorders Interview Schedule/ASA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of psychological trauma&#xD;
&#xD;
          -  History of neurologic illness&#xD;
&#xD;
          -  Parent substance abuse, bipolar disorder, psychosis&#xD;
&#xD;
          -  Parents require support from a medical interpreter&#xD;
&#xD;
          -  Child displays severe behavior challenges&#xD;
&#xD;
          -  Severe eyesight or hearing impairments that may interfere with the protocols&#xD;
&#xD;
          -  Child's behavior prevents their ability to participate in a 1 hour group consisting of&#xD;
             various activities (e.g., listening to a story, snacks, playing movement games,&#xD;
             completing a craft)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Months</minimum_age>
    <maximum_age>83 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kennedy Krieger Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Keefer A, Kreiser NL, Singh V, Blakeley-Smith A, Duncan A, Johnson C, Klinger L, Meyer A, Reaven J, Vasa RA. Intolerance of Uncertainty Predicts Anxiety Outcomes Following CBT in Youth with ASD. J Autism Dev Disord. 2017 Dec;47(12):3949-3958. doi: 10.1007/s10803-016-2852-z.</citation>
    <PMID>27405445</PMID>
  </reference>
  <reference>
    <citation>Reaven J, Moody EJ, Grofer Klinger L, Keefer A, Duncan A, O'Kelley S, Meyer A, Hepburn S, Blakeley-Smith A. Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. J Consult Clin Psychol. 2018 Mar;86(3):205-217. doi: 10.1037/ccp0000285.</citation>
    <PMID>29504790</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</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>Anxiety Disorders</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/NCT04432077
org study id: 2019A06
nct id: NCT04432077
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment
      program for anxiety in preschool children with autism spectrum disorder.
Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population,
      anxiety often emerges when children are very young, yet there are no evidence-based
      treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces
      anxiety levels in young, typically developing children and older children with ASD. This
      study pilots the DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)
      program, which is an integrated treatment program that utilizes CBT modified for young
      children with ASD. The treatment includes heavy doses of parent training to reduce
      accommodation of the child's anxiety symptoms and interventions targeting fear of
      uncertainty, a common fear in children with ASD. The feasibility, acceptability, and
      preliminary efficacy of this treatment program will be studied.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) after 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week treatment (pre-treatment to post-treatment)
description: clinician administered, semi-structured interview assessing anxiety disorders; clinical severity ratings range from 0 to 3 or 0 to 8; higher scores indicate more impairment
measure: Improvement in child anxiety symptoms on Clinical Global Impressions Scale-Improvement following 12-week intervention
time frame: Following 12-week intervention (post-treatment)
description: used to assess treatment response; scores range from 1 (very much improved) to 7 (very much worse)
measure: Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety
measure: Change in child anxiety symptoms on the Screen for Child Anxiety Related Disorders following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: parent and teacher report scale measuring levels of anxiety in children older than 5 years old; scores range from 0 to 114; higher scores indicate higher anxiety
measure: Change in severity of anxiety and other psychiatric symptoms on Child Behavior Checklist following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: an established 99-item parent and teacher report of broad psychopathology; T scores range from 20 to 100; Syndrome scales: T-scores over 65 indicate clinically significant symptoms
measure: Change in child's tolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: parent and teacher report scale measuring response to uncertainty and low environmental structure; scores range from 1 to 5; higher scores indicate higher intolerance of uncertainty
measure: Change in child ASD symptoms on Social Responsiveness Scale following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: parent report scale that assesses the presence and severity of social impairment in children; T-scores range from 20 to 100; higher scores indicate higher ASD severity
measure: Change in child repetitive behaviors on Repetitive Behavior Scale-Revised following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: parent-report measure of repetitive behavior in children with ASD; scores range from 0 to 176; higher scores indicate greater impairment
measure: Change in parental anxiety and depression symptoms on Hospital Anxiety and Depression Scale following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: parental screening tool that captures clinical anxiety and depression; scores range from 0 to 21; higher scores indicate higher anxiety and/or depression symptoms
measure: Change in parental tolerance of uncertainty on Intolerance of Uncertainty Scale following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week wailist (baseline to pre-treatment); Before and after 12-week intervention
description: parental scale that measures responses to uncertainty, ambiguous situations and the future; scores range from 12 to 60; higher scores indicate higher intolerance of uncertainty
measure: Change on parental accommodating behaviors on Family Accommodation Scale following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation
measure: Change in child attention bias to threat on Behavioral Paradigms following 12-week waitlist and 12-week intervention
time frame: Before and after 12-week waitlist (pre-treatment to post-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
description: eye tracking paradigms used to assess attention bias to threat; more frequent saccades to threatening stimuli indicate higher attention bias to threat
arm group label: Treatment
arm group type: Experimental
description: All participants receive the DINOSAUR intervention
intervention type: Behavioral
intervention name: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)
description: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD
arm group label: Treatment
criteria: 
gender: All
minimum age: 48 Months
maximum age: 83 Months
healthy volunteers: No
facility: 
country: United States
citation: Keefer A, Kreiser NL, Singh V, Blakeley-Smith A, Duncan A, Johnson C, Klinger L, Meyer A, Reaven J, Vasa RA. Intolerance of Uncertainty Predicts Anxiety Outcomes Following CBT in Youth with ASD. J Autism Dev Disord. 2017 Dec;47(12):3949-3958. doi: 10.1007/s10803-016-2852-z.
PMID: 27405445
citation: Reaven J, Moody EJ, Grofer Klinger L, Keefer A, Duncan A, O'Kelley S, Meyer A, Hepburn S, Blakeley-Smith A. Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. J Consult Clin Psychol. 2018 Mar;86(3):205-217. doi: 10.1037/ccp0000285.
PMID: 29504790
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Autism Spectrum Disorder
sharing ipd: No