xml: <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/NCT06011707</url>
    </required_header>
    <id_info>
      <org_study_id>OPTIN</org_study_id>
      <nct_id>NCT06011707</nct_id>
    </id_info>
    <brief_title>OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder</brief_title>
    <official_title>OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Elizabeth Kelley</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>McMaster Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Holland Bloorview Kids Rehabilitation Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's Hospital of Eastern Ontario</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Child and Community Resources</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Queen's University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observer-blinded randomized controlled clinical trial is to determine the&#xD;
        effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for&#xD;
        young children with autism (12-60 months) who have been diagnosed with autism in the last six&#xD;
        months. The main question[s] it aims to answer are:&#xD;
  &#xD;
          1. Does an online intervention for autistic children result in improved adaptive behaviour,&#xD;
             compared to a psychoeducational control group?&#xD;
  &#xD;
          2. Does an online intervention for autistic children result in reduced autism symptoms in&#xD;
             children, and decreased stress and increased self-efficacy in parents, compared to a&#xD;
             psychoeducational control group?&#xD;
  &#xD;
          3. What are the predictors of response to intervention (i.e., child sex and age; initial&#xD;
             autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education).&#xD;
  &#xD;
        Parents will be given six compulsory and eight optional online modules that will teach them&#xD;
        skills to use while interacting with their autistic children to improve social and&#xD;
        communication behaviours and minimize behaviours that interfere with learning.&#xD;
  &#xD;
        The comparison group will receive six compulsory and eight optional online modules that will&#xD;
        teach them about autism more broadly including diagnostic criteria, symptom profiles across&#xD;
        development, etc.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">March 2028</completion_date>
    <primary_completion_date type="Anticipated">March 2028</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>The students who will be conducting the interviews for the primary objective of the study (using the Vineland Adaptive Behavior Scales, Version 3) will be blind to the treatment arm the family is assigned to.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Adaptive Behavior</measure>
      <time_frame>baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)</time_frame>
      <description>Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Autism Symptoms</measure>
      <time_frame>baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)</time_frame>
      <description>Change in Autism Impact Measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Parenting Stress</measure>
      <time_frame>baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)</time_frame>
      <description>Change in Parenting Stress Index, Short Form, version 4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Parental Self-Efficacy</measure>
      <time_frame>baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)</time_frame>
      <description>Change in Early Intervention Parenting Self-Efficacy Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Language</measure>
      <time_frame>baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)</time_frame>
      <description>Change in MacArthur-Bates Communicative Development Inventory</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">308</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>OPT-IN intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Psychoeducational control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>OPT-IN</intervention_name>
      <description>Parents will be provided with online access to 6 compulsory video-based modules and 8 optional video-based modules. These modules will teach them about child development, behavioural principles, and naturalistic developmental intervention principles. These modules will promote skills that parents can use to increase their child's social and communication behaviours and minimize behaviours that interfere with learning (e.g., temper tantrums).</description>
      <arm_group_label>OPT-IN intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Psychoeducational control</intervention_name>
      <description>This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.</description>
      <arm_group_label>Psychoeducational control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at&#xD;
               baseline&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Parent does not speak English well enough to complete questionnaires&#xD;
  &#xD;
            -  Parent or child has complete vision or hearing loss.&#xD;
  &#xD;
            -  Parent or child is medically unstable.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>60 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Elizabeth A Kelley, PhD</last_name>
      <phone>613-533-2491</phone>
      <email>kelleyb@queensu.ca</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Queen's University</investigator_affiliation>
      <investigator_full_name>Elizabeth Kelley</investigator_full_name>
      <investigator_title>Dr. Elizabeth Kelley, PhD, Associate professor of Psychology and Psychiatry and CNS, Queen's University</investigator_title>
    </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>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be shared with other researchers through this website. The data will be de-identified by eliminating birthdate.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The data will be made available after publication for 15 years.</ipd_time_frame>
      <ipd_access_criteria>Data will be obtained through the clinicaltrials.gov website</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011707
  org study id: OPTIN
  nct id: NCT06011707
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observer-blinded randomized controlled clinical trial is to determine the
        effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for
        young children with autism (12-60 months) who have been diagnosed with autism in the last six
        months. The main question[s] it aims to answer are:
  
          1. Does an online intervention for autistic children result in improved adaptive behaviour,
             compared to a psychoeducational control group?
  
          2. Does an online intervention for autistic children result in reduced autism symptoms in
             children, and decreased stress and increased self-efficacy in parents, compared to a
             psychoeducational control group?
  
          3. What are the predictors of response to intervention (i.e., child sex and age; initial
             autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education).
  
        Parents will be given six compulsory and eight optional online modules that will teach them
        skills to use while interacting with their autistic children to improve social and
        communication behaviours and minimize behaviours that interfere with learning.
  
        The comparison group will receive six compulsory and eight optional online modules that will
        teach them about autism more broadly including diagnostic criteria, symptom profiles across
        development, etc.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: The students who will be conducting the interviews for the primary objective of the study (using the Vineland Adaptive Behavior Scales, Version 3) will be blind to the treatment arm the family is assigned to.
  measure: Change in Adaptive Behavior
  time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
  description: Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview
  measure: Change in Autism Symptoms
  time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
  description: Change in Autism Impact Measure
  measure: Change in Parenting Stress
  time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
  description: Change in Parenting Stress Index, Short Form, version 4
  measure: Change in Parental Self-Efficacy
  time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
  description: Change in Early Intervention Parenting Self-Efficacy Scale
  measure: Change in Language
  time frame: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
  description: Change in MacArthur-Bates Communicative Development Inventory
  arm group label: OPT-IN intervention
  arm group type: Experimental
  arm group label: Psychoeducational control
  arm group type: Active Comparator
  intervention type: Behavioral
  intervention name: OPT-IN
  description: Parents will be provided with online access to 6 compulsory video-based modules and 8 optional video-based modules. These modules will teach them about child development, behavioural principles, and naturalistic developmental intervention principles. These modules will promote skills that parents can use to increase their child's social and communication behaviours and minimize behaviours that interfere with learning (e.g., temper tantrums).
  arm group label: OPT-IN intervention
  intervention type: Other
  intervention name: Psychoeducational control
  description: This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.
  arm group label: Psychoeducational control
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: 60 Months
  healthy volunteers: No
  last name: Elizabeth A Kelley, PhD
  phone: 613-533-2491
  email: kelleyb@queensu.ca
  responsible party type: Sponsor-Investigator
  investigator affiliation: Queen's University
  investigator full name: Elizabeth Kelley
  investigator title: Dr. Elizabeth Kelley, PhD, Associate professor of Psychology and Psychiatry and CNS, Queen's University
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: Yes
  ipd description: Data will be shared with other researchers through this website. The data will be de-identified by eliminating birthdate.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: The data will be made available after publication for 15 years.
  ipd access criteria: Data will be obtained through the clinicaltrials.gov website