<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/NCT03274622</url>
  </required_header>
  <id_info>
    <org_study_id>140924</org_study_id>
    <secondary_id>1R01DC013767-01</secondary_id>
    <nct_id>NCT03274622</nct_id>
  </id_info>
  <brief_title>Efficacy of IMPACT in Infant Siblings of Children With ASD</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>Efficacy of Parent-implemented Treatment in Infant Siblings of Children With Autism Spectrum Disorder (ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</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>
      Over a 5 year period infant and baby siblings of children with autism spectrum disorders&#xD;
      (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the&#xD;
      intervention group will receive 12 weeks of coaching in how to implement this intervention.&#xD;
      Parents randomized to the control group will not receive intervention coaching. Both groups&#xD;
      will attend a series of clinic appointments for data collection that occur at 3 month&#xD;
      intervals over a 9 month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This two-site randomized controlled trail (RCT) will include a sample of 80 siblings of&#xD;
      children with ASD (Sibs-ASD) (11 months, 15 days to 18 months, 15 days) who are stratified on&#xD;
      initial cumulative-risk status for communication disorder and then randomly assigned to&#xD;
      Ingersoll's Improving Parents As Communication Teachers (ImPACT; Ingersoll &amp; Dvortcsak, 2010)&#xD;
      treatment or to a business-as-usual (BAU) control condition. The following hypotheses will be&#xD;
      tested:&#xD;
&#xD;
        1. Compared to the BAU Control, children assigned to the ImPACT group will show (a) more&#xD;
           growth on pivotal skills and language level, and (b) a lesser degree of ASD&#xD;
           symptomatology and language delay.&#xD;
&#xD;
        2. Pretreatment, cumulative-risk level will statistically interact with (i.e., moderate)&#xD;
           treatment assignment to predict children's (a) change in pivotal skills and language,&#xD;
           and (b) severity of autism symptoms and language delay.&#xD;
&#xD;
        3. Compared to the BAU Control, parents in ImPACT will have more optimal parenting stress&#xD;
           and parenting efficacy, at least in parents with average or below average depressive&#xD;
           symptoms prior to treatment (i.e., depressive symptoms will moderate the effect of&#xD;
           ImPACT on parental stress and parenting efficacy).&#xD;
&#xD;
        4. The effect that ImPACT has on growth of pivotal skills and language will be mediated by&#xD;
           parents' frequency and fidelity of use of ImPACT strategies at immediate post-treatment.&#xD;
&#xD;
        5. The effect of ImPACT on degree of children's language delay and ASD symptomatology at 6&#xD;
           months post-treatment will be mediated by their pivotal skill level at 3 months&#xD;
           post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2016</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The assessors and coders are blind to treatment assignment. This will be achieved by using different people to conduct the treatment vs assessment and coding. Additionally, these different staff members have offices on different floors.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Growth in communication</measure>
    <time_frame>Change between baseline and 9 months after entry</time_frame>
    <description>weighted frequency of intentional communication from the Communication and Symbolic Behavior Scale, high is good range is 0 - 400</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth in play</measure>
    <time_frame>Change from Baseline to 9 months after entry</time_frame>
    <description>raw scores from Developmental Play Assessment, high is good, range is 0 to 50</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor imitation</measure>
    <time_frame>Change from Baseline to 9 months after entry</time_frame>
    <description>raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autism social affect symptomatology</measure>
    <time_frame>9 months after entry</time_frame>
    <description>average of z score from raw scores from Communication and Symbolic Behavior Scale and Autism Diagnositic Observation Schedule (reflected) if they are correlated &gt; .4, after reflection high is good, -4 to 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Language delay</measure>
    <time_frame>9 months after entry</time_frame>
    <description>average of z scores from standard scores or percentile rankings from MacAuthur Communication Development Index and Mullen Scale of Early Learning if they are correlated above .4, high is good, range is -4 to 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>language level</measure>
    <time_frame>Change from baseline to 9 mos after treatment ends</time_frame>
    <description>average of time 4-referenced z scores from raw scores from Communication and Symbolic Behavior Scales, Brief Observation of Social Communication Change, and MacArthur Communication Development Index if they are correlated above .4, High is good, -4 to 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parent implementation of ImPACT treatment</measure>
    <time_frame>change from baseline to immediately post-treatment</time_frame>
    <description>fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Impact Parent Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents receive 22 1.5-hour sessions with a Speech Language pathologist coaching them in the implementation of the Impact intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Impact</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No parent coaching is provided</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Impact Parent Training</intervention_name>
    <arm_group_label>Impact Parent Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No Impact</intervention_name>
    <arm_group_label>No Impact</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Younger sibling of a child with ASD -&#xD;
&#xD;
          1. Age: 11 months, 15 days to 18 months, 15 days&#xD;
&#xD;
          2. Older biological sibling: Must have a diagnosis of Autism from UW or VU, which is&#xD;
             confirmed via record review. If the older sibling was not diagnosed at UW or VU, then&#xD;
             a diagnostic appointment must be made for the older sibling at the corresponding&#xD;
             institution in order to confirm the diagnosis of ASD. Half-siblings are ok.&#xD;
&#xD;
          3. Vision - WNL corrected&#xD;
&#xD;
          4. Hearing - WNL corrected&#xD;
&#xD;
          5. Motor: The child must be able to sit independently while picking up objects and giving&#xD;
             them to another person.&#xD;
&#xD;
        Exclusions:&#xD;
&#xD;
        No primary motor impairment. No feeding tubes. No other neurological or genetic conditions.&#xD;
        Primary language exposure: The primary parent speak to the child using English 50% of the&#xD;
        time, and process.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul J. Yoder, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195-7920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Paul Yoder</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03274622
org study id: 140924
secondary id: 1R01DC013767-01
nct id: NCT03274622
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Over a 5 year period infant and baby siblings of children with autism spectrum disorders
      (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the
      intervention group will receive 12 weeks of coaching in how to implement this intervention.
      Parents randomized to the control group will not receive intervention coaching. Both groups
      will attend a series of clinic appointments for data collection that occur at 3 month
      intervals over a 9 month period.
This two-site randomized controlled trail (RCT) will include a sample of 80 siblings of
      children with ASD (Sibs-ASD) (11 months, 15 days to 18 months, 15 days) who are stratified on
      initial cumulative-risk status for communication disorder and then randomly assigned to
      Ingersoll's Improving Parents As Communication Teachers (ImPACT; Ingersoll & Dvortcsak, 2010)
      treatment or to a business-as-usual (BAU) control condition. The following hypotheses will be
      tested:

        1. Compared to the BAU Control, children assigned to the ImPACT group will show (a) more
           growth on pivotal skills and language level, and (b) a lesser degree of ASD
           symptomatology and language delay.

        2. Pretreatment, cumulative-risk level will statistically interact with (i.e., moderate)
           treatment assignment to predict children's (a) change in pivotal skills and language,
           and (b) severity of autism symptoms and language delay.

        3. Compared to the BAU Control, parents in ImPACT will have more optimal parenting stress
           and parenting efficacy, at least in parents with average or below average depressive
           symptoms prior to treatment (i.e., depressive symptoms will moderate the effect of
           ImPACT on parental stress and parenting efficacy).

        4. The effect that ImPACT has on growth of pivotal skills and language will be mediated by
           parents' frequency and fidelity of use of ImPACT strategies at immediate post-treatment.

        5. The effect of ImPACT on degree of children's language delay and ASD symptomatology at 6
           months post-treatment will be mediated by their pivotal skill level at 3 months
           post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The assessors and coders are blind to treatment assignment. This will be achieved by using different people to conduct the treatment vs assessment and coding. Additionally, these different staff members have offices on different floors.
measure: Growth in communication
time frame: Change between baseline and 9 months after entry
description: weighted frequency of intentional communication from the Communication and Symbolic Behavior Scale, high is good range is 0 - 400
measure: Growth in play
time frame: Change from Baseline to 9 months after entry
description: raw scores from Developmental Play Assessment, high is good, range is 0 to 50
measure: Motor imitation
time frame: Change from Baseline to 9 months after entry
description: raw scores from the Structured Social Imitation Scale, high is good, range 0 - 50
measure: Autism social affect symptomatology
time frame: 9 months after entry
description: average of z score from raw scores from Communication and Symbolic Behavior Scale and Autism Diagnositic Observation Schedule (reflected) if they are correlated > .4, after reflection high is good, -4 to 4
measure: Language delay
time frame: 9 months after entry
description: average of z scores from standard scores or percentile rankings from MacAuthur Communication Development Index and Mullen Scale of Early Learning if they are correlated above .4, high is good, range is -4 to 4
measure: language level
time frame: Change from baseline to 9 mos after treatment ends
description: average of time 4-referenced z scores from raw scores from Communication and Symbolic Behavior Scales, Brief Observation of Social Communication Change, and MacArthur Communication Development Index if they are correlated above .4, High is good, -4 to 4
measure: parent implementation of ImPACT treatment
time frame: change from baseline to immediately post-treatment
description: fidelity of treatment of aspects of ImPACT treatment from PCS and PCFP
arm group label: Impact Parent Training
arm group type: Experimental
description: Parents receive 22 1.5-hour sessions with a Speech Language pathologist coaching them in the implementation of the Impact intervention
arm group label: No Impact
arm group type: Placebo Comparator
description: No parent coaching is provided
intervention type: Behavioral
intervention name: Impact Parent Training
arm group label: Impact Parent Training
intervention type: Behavioral
intervention name: No Impact
arm group label: No Impact
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Months
healthy volunteers: No
last name: Paul J. Yoder, Ph.D.
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Paul Yoder
investigator title: Professor
mesh term: Autism Spectrum Disorder
sharing ipd: No