<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/NCT03307057</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00098127</org_study_id>
    <secondary_id>P50MH100029</secondary_id>
    <nct_id>NCT03307057</nct_id>
  </id_info>
  <brief_title>Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families</brief_title>
  <official_title>Promoting Transactional Supports to Optimize Social Communication Outcomes for Infants and Their Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory 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>
      This early treatment project is designed to address two significant public health challenges&#xD;
      - the need for validated, manualized, treatments for young children with Autism Spectrum&#xD;
      Disorder (ASD) that are cost-efficient and feasible for community-based implementation, and&#xD;
      the need to reduce the age of entry into early intervention to optimize outcomes. This study&#xD;
      will use a 2-stage sequential multiple assignment randomized trial (SMART) design to develop&#xD;
      an adaptive intervention by comparing individual and combined effects of preventative parent&#xD;
      education and autism treatment starting in infancy. All parent-infant dyads from the pool of&#xD;
      250 high and low risk siblings in the Emory Autism Center of Excellence (ACE) will be invited&#xD;
      at 6 months of age and randomly assigned at Stage 1 to the Social Communication Growth Charts&#xD;
      (SCGC) that use an innovative web-based technology to teach parents early social&#xD;
      communication milestones and how to support their child's development very early or Usual&#xD;
      Care (UC), in order to compare the efficacy on developmental trajectories from 9 to 30&#xD;
      months. Families of children who show early signs of ASD at 12 months of age based on&#xD;
      tailoring variables using parent report and observational measures will be re-randomized at&#xD;
      Stage 2 to compare efficacy of a parent-implemented (P-I) condition of a naturalistic&#xD;
      developmental behavioral intervention (NDBI) based on the Early Social Interaction (ESI)1&#xD;
      model to a clinician-implemented (C-I) condition of NDBI based on a hybrid model from 12 to&#xD;
      21 months of age. The investigators anticipate that 80 children will show early signs of ASD&#xD;
      and that 56 families (70%) will agree to participate in the Stage 2 treatment. Growth&#xD;
      trajectories of parent contingent responsiveness and child social communication will be&#xD;
      collected longitudinally with repeated measures at 9, 12, 16, 21, and 30 months. Outcome&#xD;
      measures of autism symptoms, developmental level, and adaptive behavior will be examined at&#xD;
      21 and 30 months to measure differential treatment effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most children with autism spectrum disorders (ASD) require special education at school age at&#xD;
      staggering expenses to the educational system. The average annual cost for educating a child&#xD;
      with ASD, based on the US Government Accountability Office, is $18,790, compared to $12,500&#xD;
      for the average special education student, and $6,556 for a regular education student. With&#xD;
      effective early intervention (EI) services, the future is more promising. Through prior&#xD;
      research, it is known that providing intervention early has a greater impact; between 60 and&#xD;
      90% of children in intensive early treatment programs beginning by age 3 can learn to talk&#xD;
      compared to 50% without early treatment, and about half can make it into regular&#xD;
      kindergarten, compared to 10% without early treatment. While there is a national priority for&#xD;
      early intervention as evident in the mandate of Part C of the Individuals with Disabilities&#xD;
      Education Act (IDEA), there is a need for research on effective and feasible early&#xD;
      intervention programs for infants and toddlers with ASD.&#xD;
&#xD;
      The recommendations of the American Academy of Pediatrics to screen all children for ASD at&#xD;
      18-24 months of age makes the need for evidence-based interventions for toddlers with ASD&#xD;
      even more pressing. Advances in research have documented that ASD can be diagnosed reliably&#xD;
      by trained professionals at 18-24 months of age. And yet, the median age of diagnosis in the&#xD;
      US is 4-5 years. Lower income, minority, and rural families receive a diagnosis up to a year&#xD;
      and a half later, well beyond the opportunity for EI. Because the usual age of diagnosis of&#xD;
      ASD is between 3 and 6 years of age, there is limited research on early intervention for&#xD;
      infants and toddlers with ASD. Disparities in the age of detection of ASD delay the age of&#xD;
      entry into intervention for children from underserved families. Compounding this problem,&#xD;
      underserved families are underrepresented in intervention research, making them a critically&#xD;
      important population to target in future research. It is vitally important to develop and&#xD;
      document the effectiveness of interventions that could be implemented by public IDEA Part C&#xD;
      service delivery program in community-base settings and that are feasible for low income and&#xD;
      other underserved families.&#xD;
&#xD;
      The overarching goal of this treatment project is to document the efficacy of very early&#xD;
      transactional supports that parents can learn to change developmental trajectories and&#xD;
      optimize outcomes of their child using a 2-stage sequential multiple assignment randomized&#xD;
      trial (SMART) design to develop an adaptive intervention. All parent-infant dyads in the&#xD;
      Emory Autism Center of Excellence (ACE) will be invited at 6 months of age from the pool of&#xD;
      250 high and low risk siblings and will be randomly assigned at Stage 1 of this clinical&#xD;
      trial. In Stage 1, parents of participating children are randomized to a group utilizing the&#xD;
      Social Communication Growth Charts (SCGC), which use an innovative web-based technology to&#xD;
      teach parents early social communication milestones and how to support their child's very&#xD;
      early development, or Usual Care. This first stage of the study will compare efficacy of the&#xD;
      SCGC on parent contingent responsiveness and child developmental trajectories.&#xD;
&#xD;
      Families of children who show early signs of ASD at 12 months of age will be re-randomized to&#xD;
      Stage 2. The goal of Stage 2 of the study is to compare the efficacy of a parent-implemented&#xD;
      (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the&#xD;
      Early Social Interaction model, to a clinician-implemented (C-I) condition NDBI based on a&#xD;
      hybrid model. Children will receive the Stage 2 intervention from 12 to 21 months of age.&#xD;
&#xD;
      Outcome measures of social communication, autism symptoms, social visual engagement,&#xD;
      developmental level, and adaptive behavior will be gathered every 6 months from 6 to 30&#xD;
      months of age to measure treatment effects. Measures of parent transactional support and&#xD;
      child active engagement will be collected quarterly from 9 to 30 months of age to examine&#xD;
      growth trajectories during the Stage 1 and 2 conditions and at follow-up at 21 and 30 months&#xD;
      after intervention. The expected impact of this study will have the following important&#xD;
      implications: 1) maximize the use of technology to teach all parents how to support their&#xD;
      infant's development early to optimize opportunities for learning and recognize as early as&#xD;
      possible if their child is not meeting developmental milestones and may need intervention; 2)&#xD;
      document improved outcomes for very young children with early signs of ASD receiving a&#xD;
      manualized, evidence-based NDBI intervention that is cost-efficient and feasible for&#xD;
      community-based implementation; and 3) substantiate that these adaptive interventions&#xD;
      implemented by parents beginning at 6 months of age lead to better child outcomes, providing&#xD;
      evidence that very early detection of autism is crucial to improve developmental outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">June 23, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 23, 2023</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>Sequential Assignment</intervention_model>
    <intervention_model_description>This study uses a 2-stage sequential multiple assignment randomized trial (SMART) design to develop an adaptive intervention. Participants will be randomized into one of two study arms at Stage 1 (6 months of age) and re-randomized into one of four arms for Stage 2 at 12 months of age. Certain study arms during Stage 2 will only be available for participants who are showing early signs of ASD.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The diagnosticians for all measures will be kept blind to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Measure of Active Engagement and Transactional Supports (MAETS) Score</measure>
    <time_frame>9, 12, 16, 21, and 30 months of age</time_frame>
    <description>Parent contingent responsiveness will be assessed using the Transactional Support section of the Measure of Active Engagement and Transactional Supports (MAETS). This assessment will occur during home observation of everyday activities. This section includes 8 components: promoting participation and a productive role, providing structure to make activities predictable, using language that follows the child's focus of attention, promoting child initiations, providing a balance of communicative turns, supporting the development of child comprehension, providing verbal and nonverbal models, caregiver creates appropriate expectations and demands. Each component is scored on a 4 point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, 3 = Mastery. Total scores range from 0 to 32 and lower scores indicate that the level of support is low.&#xD;
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Communication and Symbolic Behavior Scales (CSBS) Score</measure>
    <time_frame>9, 12, 16, 21, and 30 months of age</time_frame>
    <description>Change in social communication skills will be measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later converted scores. The raw scores will be summed to form a social, speech, and symbolic composite.&#xD;
The social composite includes emotion and eye gaze, communication and gestures, and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all three composites range from 0 to 171.&#xD;
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Autism Diagnostic Observation Schedule Score</measure>
    <time_frame>9, 12, 16, 21, and 30 months of age</time_frame>
    <description>Autism symptoms will be measured with the Autism Diagnostic Observation Schedule, Second Edition is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.&#xD;
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mullen Scales of Early Learning Score</measure>
    <time_frame>9, 12, 16, 21, and 30 months of age</time_frame>
    <description>This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level. with separate scores for four cognitive scales that form an early learning composite. A nonverbal developmental quotient (DQ) based on age equivalent divided by chronological age multiplied by 100 will be calculated from the average of the Fine Motor and Visual Reception scales. A verbal DQ will be calculated from the Expressive Language and Receptive Language scales.&#xD;
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vineland-3 Adaptive Behavior Scales Score</measure>
    <time_frame>9, 12, 16, 21, and 30 months of age</time_frame>
    <description>Adaptive Behavior will be measured with the Vineland-3 Adaptive Behavior Scales. The Vineland-3 provides a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills, which yield an Adaptive Behavior Composite score. The normative mean score of the Adaptive Behavior Composite is 100 with a normative standard deviation of 15.&#xD;
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Measure of Active Engagement and Transactional Supports (MAETS) in Parents of Children Showing Signs of ASD</measure>
    <time_frame>12 months of age to 21 months of age</time_frame>
    <description>Parent contingent responsiveness will be assessed during home observation of everyday activities. Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Communication and Symbolic Behavior Scales (CSBS) Score in Children Showing Signs of ASD</measure>
    <time_frame>12 months of age to 21 months of age</time_frame>
    <description>Change in social communication skills will be measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later converted scores. The raw scores will be summed to form a social, speech, and symbolic composite.&#xD;
The social composite includes emotion and eye gaze, communication and gestures, and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all three composites range from 0 to 171.&#xD;
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Autism Diagnostic Observation Schedule Score in Children Showing Signs of ASD</measure>
    <time_frame>12 months of age to 21 months of age</time_frame>
    <description>Autism symptoms will be measured with the Autism Diagnostic Observation Schedule, Second Edition is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.&#xD;
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mullen Scales of Early Learning Score in Children Showing Signs of ASD</measure>
    <time_frame>12 months of age to 21 months of age</time_frame>
    <description>This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level. with separate scores for four cognitive scales that form an early learning composite. A nonverbal developmental quotient (DQ) based on age equivalent divided by chronological age multiplied by 100 will be calculated from the average of the Fine Motor and Visual Reception scales. A verbal DQ will be calculated from the Expressive Language and Receptive Language scales.&#xD;
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vineland-3 Adaptive Behavior Scales Score in Children Showing Signs of ASD</measure>
    <time_frame>12 months of age to 21 months of age</time_frame>
    <description>Adaptive Behavior will be measured with the Vineland-3 Adaptive Behavior Scales. The Vineland-3 provides a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills, which yield an Adaptive Behavior Composite score. The normative mean score of the Adaptive Behavior Composite is 100 with a normative standard deviation of 15.&#xD;
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Social Communication Growth Charts (SCGC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants with a sibling who is diagnosed with ASD, who are randomized to receive the Social Communication Growth Charts (SCGC) intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infants with a sibling who is diagnosed with ASD, who are randomized to receive usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent-Implemented (P-I) Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants showing early signs of ASD at 12 months of age, randomized to receive a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the Early Social Interaction model.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinician-Implemented (C-I) Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants showing early signs of ASD at 12 months of age, randomized to receive a clinician-implemented (C-I) condition NDBI based on a hybrid model.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Communication Growth Charts (SCGC)</intervention_name>
    <description>The Social Communication Growth Charts (SCGC) is a web-based tool that parents can access to teach them the social communication milestones that are developing from 6 to 24 months of age. The SCGC has an explore function with hundreds of video clips illustrating 80 social communication milestones and a support video that has narration explaining how the parent in the video is supporting the child's development. The SCGC also has a charting function that parents can use by answering questions about their child's social communication milestones and then view charts in 5 developmental domains. Parents in the SCGC condition are also invited to a bi-weekly online Guided Tour to join other parents in a group meeting, like a book club, as they go through the SCGC.</description>
    <arm_group_label>Social Communication Growth Charts (SCGC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent-Implemented (P-I) Condition</intervention_name>
    <description>The Parent-Implemented (P-I) condition is based on the Early Social Interaction (ESI) model, which is an evidence-based parent-implemented intervention involving active and productive engagement for 5 hours per day, 5 days per week for toddlers with ASD. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places.&#xD;
Weekly home sessions with a family navigator include:&#xD;
developing the visit agenda&#xD;
intervention implementation including: guided/caregiver practice, feedback and problem solving&#xD;
planning for parent implementation between sessions&#xD;
Families can also access the Autism Navigator How-To Guide for Families (a self-guided, web-based course), the Online Guided Tour for the How-To Guide (an online group to engage families), and have the opportunity to interact with other families who suspect their child has autism through audio or video conferencing or typed chat.</description>
    <arm_group_label>Parent-Implemented (P-I) Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinician-Implemented (C-I) Condition</intervention_name>
    <description>The Clinician-Implemented (C-I) condition is based on the core principles of empirically-supported naturalistic developmental behavioral interventions (NDBI) for infants and toddlers with or at-risk for ASD, including Early Start Denver Model (ESDM), Project ImPACT (Improving Parents As Communication Teachers), Pivotal Response Treatment (PRT), and Early Social Interaction (ESI). The goal of C-I NDBI is to use naturalistic, developmental, and behavioral strategies with infants at-risk for ASD to improve social-communication, which includes eye contact, gesture use, intentional vocalizations, and language. Parents are not actively involved in C-I NDBI intervention sessions, though they may observe and the clinician will be given information about current social-communication targets.</description>
    <arm_group_label>Clinician-Implemented (C-I) Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Stage 1:&#xD;
&#xD;
          -  Have an ASD sibling who is in the Emory Autism Center of Excellence.&#xD;
&#xD;
        Inclusion Criteria for Stage 2:&#xD;
&#xD;
          -  Nonresponse to Stage 1 intervention; a &quot;nonresponder&quot; is defined as infants who show&#xD;
             early signs of autism and communication delay.&#xD;
&#xD;
          -  Shows early signs of ASD, defined by a positive score on the Infant-Toddler Checklist&#xD;
             (ITC) and at least two of the following autism screening tools: Early Screening for&#xD;
             Autism and Communication Disorders (ESAC), Systematic Observation of Red Flags of ASD&#xD;
             (SORF) Clinic, or SORF-Home.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent/caregiver declines to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Call, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marcus Autism Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Nathan A. Call</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pediatrics</keyword>
  <keyword>Behavioral Research</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 21, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03307057/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03307057
org study id: IRB00098127
secondary id: P50MH100029
nct id: NCT03307057
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This early treatment project is designed to address two significant public health challenges
      - the need for validated, manualized, treatments for young children with Autism Spectrum
      Disorder (ASD) that are cost-efficient and feasible for community-based implementation, and
      the need to reduce the age of entry into early intervention to optimize outcomes. This study
      will use a 2-stage sequential multiple assignment randomized trial (SMART) design to develop
      an adaptive intervention by comparing individual and combined effects of preventative parent
      education and autism treatment starting in infancy. All parent-infant dyads from the pool of
      250 high and low risk siblings in the Emory Autism Center of Excellence (ACE) will be invited
      at 6 months of age and randomly assigned at Stage 1 to the Social Communication Growth Charts
      (SCGC) that use an innovative web-based technology to teach parents early social
      communication milestones and how to support their child's development very early or Usual
      Care (UC), in order to compare the efficacy on developmental trajectories from 9 to 30
      months. Families of children who show early signs of ASD at 12 months of age based on
      tailoring variables using parent report and observational measures will be re-randomized at
      Stage 2 to compare efficacy of a parent-implemented (P-I) condition of a naturalistic
      developmental behavioral intervention (NDBI) based on the Early Social Interaction (ESI)1
      model to a clinician-implemented (C-I) condition of NDBI based on a hybrid model from 12 to
      21 months of age. The investigators anticipate that 80 children will show early signs of ASD
      and that 56 families (70%) will agree to participate in the Stage 2 treatment. Growth
      trajectories of parent contingent responsiveness and child social communication will be
      collected longitudinally with repeated measures at 9, 12, 16, 21, and 30 months. Outcome
      measures of autism symptoms, developmental level, and adaptive behavior will be examined at
      21 and 30 months to measure differential treatment effects.
Most children with autism spectrum disorders (ASD) require special education at school age at
      staggering expenses to the educational system. The average annual cost for educating a child
      with ASD, based on the US Government Accountability Office, is $18,790, compared to $12,500
      for the average special education student, and $6,556 for a regular education student. With
      effective early intervention (EI) services, the future is more promising. Through prior
      research, it is known that providing intervention early has a greater impact; between 60 and
      90% of children in intensive early treatment programs beginning by age 3 can learn to talk
      compared to 50% without early treatment, and about half can make it into regular
      kindergarten, compared to 10% without early treatment. While there is a national priority for
      early intervention as evident in the mandate of Part C of the Individuals with Disabilities
      Education Act (IDEA), there is a need for research on effective and feasible early
      intervention programs for infants and toddlers with ASD.

      The recommendations of the American Academy of Pediatrics to screen all children for ASD at
      18-24 months of age makes the need for evidence-based interventions for toddlers with ASD
      even more pressing. Advances in research have documented that ASD can be diagnosed reliably
      by trained professionals at 18-24 months of age. And yet, the median age of diagnosis in the
      US is 4-5 years. Lower income, minority, and rural families receive a diagnosis up to a year
      and a half later, well beyond the opportunity for EI. Because the usual age of diagnosis of
      ASD is between 3 and 6 years of age, there is limited research on early intervention for
      infants and toddlers with ASD. Disparities in the age of detection of ASD delay the age of
      entry into intervention for children from underserved families. Compounding this problem,
      underserved families are underrepresented in intervention research, making them a critically
      important population to target in future research. It is vitally important to develop and
      document the effectiveness of interventions that could be implemented by public IDEA Part C
      service delivery program in community-base settings and that are feasible for low income and
      other underserved families.

      The overarching goal of this treatment project is to document the efficacy of very early
      transactional supports that parents can learn to change developmental trajectories and
      optimize outcomes of their child using a 2-stage sequential multiple assignment randomized
      trial (SMART) design to develop an adaptive intervention. All parent-infant dyads in the
      Emory Autism Center of Excellence (ACE) will be invited at 6 months of age from the pool of
      250 high and low risk siblings and will be randomly assigned at Stage 1 of this clinical
      trial. In Stage 1, parents of participating children are randomized to a group utilizing the
      Social Communication Growth Charts (SCGC), which use an innovative web-based technology to
      teach parents early social communication milestones and how to support their child's very
      early development, or Usual Care. This first stage of the study will compare efficacy of the
      SCGC on parent contingent responsiveness and child developmental trajectories.

      Families of children who show early signs of ASD at 12 months of age will be re-randomized to
      Stage 2. The goal of Stage 2 of the study is to compare the efficacy of a parent-implemented
      (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the
      Early Social Interaction model, to a clinician-implemented (C-I) condition NDBI based on a
      hybrid model. Children will receive the Stage 2 intervention from 12 to 21 months of age.

      Outcome measures of social communication, autism symptoms, social visual engagement,
      developmental level, and adaptive behavior will be gathered every 6 months from 6 to 30
      months of age to measure treatment effects. Measures of parent transactional support and
      child active engagement will be collected quarterly from 9 to 30 months of age to examine
      growth trajectories during the Stage 1 and 2 conditions and at follow-up at 21 and 30 months
      after intervention. The expected impact of this study will have the following important
      implications: 1) maximize the use of technology to teach all parents how to support their
      infant's development early to optimize opportunities for learning and recognize as early as
      possible if their child is not meeting developmental milestones and may need intervention; 2)
      document improved outcomes for very young children with early signs of ASD receiving a
      manualized, evidence-based NDBI intervention that is cost-efficient and feasible for
      community-based implementation; and 3) substantiate that these adaptive interventions
      implemented by parents beginning at 6 months of age lead to better child outcomes, providing
      evidence that very early detection of autism is crucial to improve developmental outcomes.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This study uses a 2-stage sequential multiple assignment randomized trial (SMART) design to develop an adaptive intervention. Participants will be randomized into one of two study arms at Stage 1 (6 months of age) and re-randomized into one of four arms for Stage 2 at 12 months of age. Certain study arms during Stage 2 will only be available for participants who are showing early signs of ASD.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The diagnosticians for all measures will be kept blind to group assignment.
measure: Change in Measure of Active Engagement and Transactional Supports (MAETS) Score
time frame: 9, 12, 16, 21, and 30 months of age
description: Parent contingent responsiveness will be assessed using the Transactional Support section of the Measure of Active Engagement and Transactional Supports (MAETS). This assessment will occur during home observation of everyday activities. This section includes 8 components: promoting participation and a productive role, providing structure to make activities predictable, using language that follows the child's focus of attention, promoting child initiations, providing a balance of communicative turns, supporting the development of child comprehension, providing verbal and nonverbal models, caregiver creates appropriate expectations and demands. Each component is scored on a 4 point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, 3 = Mastery. Total scores range from 0 to 32 and lower scores indicate that the level of support is low.
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).
measure: Change in Communication and Symbolic Behavior Scales (CSBS) Score
time frame: 9, 12, 16, 21, and 30 months of age
description: Change in social communication skills will be measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later converted scores. The raw scores will be summed to form a social, speech, and symbolic composite.
The social composite includes emotion and eye gaze, communication and gestures, and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all three composites range from 0 to 171.
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).
measure: Change in Autism Diagnostic Observation Schedule Score
time frame: 9, 12, 16, 21, and 30 months of age
description: Autism symptoms will be measured with the Autism Diagnostic Observation Schedule, Second Edition is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).
measure: Change in Mullen Scales of Early Learning Score
time frame: 9, 12, 16, 21, and 30 months of age
description: This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level. with separate scores for four cognitive scales that form an early learning composite. A nonverbal developmental quotient (DQ) based on age equivalent divided by chronological age multiplied by 100 will be calculated from the average of the Fine Motor and Visual Reception scales. A verbal DQ will be calculated from the Expressive Language and Receptive Language scales.
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).
measure: Change in Vineland-3 Adaptive Behavior Scales Score
time frame: 9, 12, 16, 21, and 30 months of age
description: Adaptive Behavior will be measured with the Vineland-3 Adaptive Behavior Scales. The Vineland-3 provides a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills, which yield an Adaptive Behavior Composite score. The normative mean score of the Adaptive Behavior Composite is 100 with a normative standard deviation of 15.
Families assigned to the Social Communication Growth Charts (SCGC) will be compared with families assigned to Usual Care (UC).
measure: Change in Measure of Active Engagement and Transactional Supports (MAETS) in Parents of Children Showing Signs of ASD
time frame: 12 months of age to 21 months of age
description: Parent contingent responsiveness will be assessed during home observation of everyday activities. Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.
measure: Change in Communication and Symbolic Behavior Scales (CSBS) Score in Children Showing Signs of ASD
time frame: 12 months of age to 21 months of age
description: Change in social communication skills will be measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver will be videotaped and later converted scores. The raw scores will be summed to form a social, speech, and symbolic composite.
The social composite includes emotion and eye gaze, communication and gestures, and possible composite scores range from 0 to 64. The speech composite includes sounds and words, and possible composite scores range from 0 to 54. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 53. The total summed score for all three composites range from 0 to 171.
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.
measure: Change in Autism Diagnostic Observation Schedule Score in Children Showing Signs of ASD
time frame: 12 months of age to 21 months of age
description: Autism symptoms will be measured with the Autism Diagnostic Observation Schedule, Second Edition is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms will be used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.
measure: Change in Mullen Scales of Early Learning Score in Children Showing Signs of ASD
time frame: 12 months of age to 21 months of age
description: This study will use four scales of the Mullen Scales of Early Learning (MSEL) to measure developmental level. with separate scores for four cognitive scales that form an early learning composite. A nonverbal developmental quotient (DQ) based on age equivalent divided by chronological age multiplied by 100 will be calculated from the average of the Fine Motor and Visual Reception scales. A verbal DQ will be calculated from the Expressive Language and Receptive Language scales.
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.
measure: Change in Vineland-3 Adaptive Behavior Scales Score in Children Showing Signs of ASD
time frame: 12 months of age to 21 months of age
description: Adaptive Behavior will be measured with the Vineland-3 Adaptive Behavior Scales. The Vineland-3 provides a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills, which yield an Adaptive Behavior Composite score. The normative mean score of the Adaptive Behavior Composite is 100 with a normative standard deviation of 15.
Families who receive the P-I condition as the adaptive intervention will be compared with those receiving the C-I intervention.
arm group label: Social Communication Growth Charts (SCGC)
arm group type: Experimental
description: Infants with a sibling who is diagnosed with ASD, who are randomized to receive the Social Communication Growth Charts (SCGC) intervention.
arm group label: Usual care
arm group type: No Intervention
description: Infants with a sibling who is diagnosed with ASD, who are randomized to receive usual care.
arm group label: Parent-Implemented (P-I) Condition
arm group type: Experimental
description: Participants showing early signs of ASD at 12 months of age, randomized to receive a parent-implemented (P-I) condition of a naturalistic developmental behavioral intervention (NDBI) based on the Early Social Interaction model.
arm group label: Clinician-Implemented (C-I) Condition
arm group type: Experimental
description: Participants showing early signs of ASD at 12 months of age, randomized to receive a clinician-implemented (C-I) condition NDBI based on a hybrid model.
intervention type: Behavioral
intervention name: Social Communication Growth Charts (SCGC)
description: The Social Communication Growth Charts (SCGC) is a web-based tool that parents can access to teach them the social communication milestones that are developing from 6 to 24 months of age. The SCGC has an explore function with hundreds of video clips illustrating 80 social communication milestones and a support video that has narration explaining how the parent in the video is supporting the child's development. The SCGC also has a charting function that parents can use by answering questions about their child's social communication milestones and then view charts in 5 developmental domains. Parents in the SCGC condition are also invited to a bi-weekly online Guided Tour to join other parents in a group meeting, like a book club, as they go through the SCGC.
arm group label: Social Communication Growth Charts (SCGC)
intervention type: Behavioral
intervention name: Parent-Implemented (P-I) Condition
description: The Parent-Implemented (P-I) condition is based on the Early Social Interaction (ESI) model, which is an evidence-based parent-implemented intervention involving active and productive engagement for 5 hours per day, 5 days per week for toddlers with ASD. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places.
Weekly home sessions with a family navigator include:
developing the visit agenda
intervention implementation including: guided/caregiver practice, feedback and problem solving
planning for parent implementation between sessions
Families can also access the Autism Navigator How-To Guide for Families (a self-guided, web-based course), the Online Guided Tour for the How-To Guide (an online group to engage families), and have the opportunity to interact with other families who suspect their child has autism through audio or video conferencing or typed chat.
arm group label: Parent-Implemented (P-I) Condition
intervention type: Behavioral
intervention name: Clinician-Implemented (C-I) Condition
description: The Clinician-Implemented (C-I) condition is based on the core principles of empirically-supported naturalistic developmental behavioral interventions (NDBI) for infants and toddlers with or at-risk for ASD, including Early Start Denver Model (ESDM), Project ImPACT (Improving Parents As Communication Teachers), Pivotal Response Treatment (PRT), and Early Social Interaction (ESI). The goal of C-I NDBI is to use naturalistic, developmental, and behavioral strategies with infants at-risk for ASD to improve social-communication, which includes eye contact, gesture use, intentional vocalizations, and language. Parents are not actively involved in C-I NDBI intervention sessions, though they may observe and the clinician will be given information about current social-communication targets.
arm group label: Clinician-Implemented (C-I) Condition
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Months
healthy volunteers: No
last name: Nathan Call, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Nathan A. Call
investigator title: Professor
mesh term: Autism Spectrum Disorder
sharing ipd: No
provided document: 