<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/NCT03782493</url>
  </required_header>
  <id_info>
    <org_study_id>U0046320</org_study_id>
    <nct_id>NCT03782493</nct_id>
  </id_info>
  <brief_title>Maximizing Outcomes for Preschoolers With Developmental Language Disorders</brief_title>
  <official_title>Maximizing Outcomes for Preschoolers With Developmental Language Disorder: Testing the Effects of a Sequentially Targeted Naturalistic Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern 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 objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu&#xD;
      Teaching-Sentence Focus (EMT-SF) intervention, implemented by caregivers and&#xD;
      interventionists, relative to a control condition enrolling 108 30-month-old children and&#xD;
      their caregivers. The central hypothesis is that intervention will result in better overall&#xD;
      child language skills at 49 months of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-site, phase 2, randomized clinical trial will be used to determine whether&#xD;
      communication support strategies are effective for improving language outcomes in children&#xD;
      with emergent developmental language disorder.&#xD;
&#xD;
      At study entry, 108 children with emergent developmental language disorder (DLD) at 30 months&#xD;
      of age will be randomly assigned 1:1 to either the EMT-SF treatment condition or a Business&#xD;
      as Usual (BAU) control group. The control group is necessary to determine the efficacy of the&#xD;
      EMT-SF intervention. The EMT-SF group is necessary to evaluate the effects of systematically&#xD;
      teaching caregivers to use these strategies. Because all children in the study have language&#xD;
      delays that will make them eligible to receive the early intervention services through the&#xD;
      state early intervention program, children in both experimental conditions will receive&#xD;
      state-provided community-based intervention according to their Individualized Family Service&#xD;
      Plan - the current standard of care or from private speech language therapy providers.&#xD;
      Children in the EMT-SF condition will receive an additional 18 months of interventionist plus&#xD;
      caregiver-implemented intervention sessions. Children in both groups will be assessed at the&#xD;
      start of the study and every 3 months until the child is 49 months old. The goal is to enroll&#xD;
      all children at 30 months of age and provide a minimum of 60 of the planned 66 sessions of&#xD;
      intervention to each child in the treatment condition; however, variability in age at study&#xD;
      entry (e.g., 30 months), intervention dosage, and number of assessment data points will be&#xD;
      addressed in the statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A stratified randomized clinical trial design will be used with site (Vanderbilt, Northwestern) and biological sex (boys, girls) as stratification factors and EMT-SF or business-as-usual (BAU) control as a randomization factor.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcomes assessors and data coders will be blind to experimental condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2)</measure>
    <time_frame>49 months</time_frame>
    <description>CELF-P2 core language score at 49 months. The core language score includes summing the scaled scores from the following subtests: Word Structure (raw score min = 0; max = 24), Sentence Structure (raw score min = 0; max = 22), and Expressive Vocabulary (raw score mix = 0; max = 40), and deriving a standardized composite score (min = 45; max = 155). These three subtests provide the best diagnostic accuracy between children with and without developmental language disorders. Thus, the Core Language Score is considered the most representative reflection of a child's overall language skills. Higher standard scores represent better language outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of different spoken words from a Language Sample</measure>
    <time_frame>Change between 30 to 49 months (measured every 3 months)</time_frame>
    <description>Slope of total number of different spoken word (NDW) roots from a Language Sample measured every 3 months from 30 to 49 months derived from a 20-minute language sample. Higher scores represent better language outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in a latent factor of grammar from a Language Sample</measure>
    <time_frame>Change between 30 to 49 months (measured every 3 months)</time_frame>
    <description>Change in a latent variable of number of different verbs, number of different subjects, tense/agreement productivity, index of productive syntax, clauses per utterance derived from a 20-minute language sample. Higher scores represent better language outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peabody Picture Vocabulary Test - 5th Edition (PPVT-5)</measure>
    <time_frame>36 months</time_frame>
    <description>PPVT standard score (min = 20, max = 160). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expressive Vocabulary Test - 3rd edition (EVT-3)</measure>
    <time_frame>36 months</time_frame>
    <description>Expressive Vocabulary Test (EVT-3) standard score (min = 20; max = 160). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2)</measure>
    <time_frame>42 months</time_frame>
    <description>Structured Photographic Expressive Language Test (SPELT P-2) raw score (min = 0; max = 40). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2)</measure>
    <time_frame>49 months</time_frame>
    <description>Structured Photographic Expressive Language Test (SPELT P-2) raw score (min = 0; max = 40). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of Early Grammatical Impairment - 3rd person singular &amp; past tense probes (TEGI)</measure>
    <time_frame>42 months</time_frame>
    <description>Test of Early Grammatical Impairment (TEGI) raw score for subscales: Third Person Singular Probe subscale (min = 0; max = 10) and the Past Tense Probe subscale (min = 0; max = 18). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of Early Grammatical Impairment - 3rd person singular &amp; past tense probes (TEGI)</measure>
    <time_frame>49 months</time_frame>
    <description>Test of Early Grammatical Impairment (TEGI) raw score for subscales: Third Person Singular Probe subscale (min = 0; max = 10) and the Past Tense Probe subscale (min = 0; max = 18). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Focus on the Outcomes of Children Under Six (FOCUS)</measure>
    <time_frame>49 months</time_frame>
    <description>Focus on the Outcomes of Children Under Six (FOCUS) total raw score (min = 0, max = 350). Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decontextualized language from a Language Sample</measure>
    <time_frame>49 months</time_frame>
    <description>Total number of utterances that contain decontextualized language from a 20-minute Language Sample. Higher scores represent better language outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renfrew Bus Story - North American Edition (RBS-NA)</measure>
    <time_frame>49 months</time_frame>
    <description>Information score (min = 0; max = 52) from the Renfrew Bus Story. Higher scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Behavior Checklist (CBCL)</measure>
    <time_frame>49 months</time_frame>
    <description>Child Behavior Checklist Internalizing T score (min = 29; max = 100). Lower scores represent better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Developmental Language Disorder</condition>
  <arm_group>
    <arm_group_label>Enhanced Milieu Teaching-Sentence Focus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Business-as-usual control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>the Enhanced Milieu Teaching-Sentence Focus</intervention_name>
    <description>Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).</description>
    <arm_group_label>Enhanced Milieu Teaching-Sentence Focus</arm_group_label>
    <other_name>EMT-SF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent or caregiver (mother, father, grandparent) willing to participate in caregiver&#xD;
             training over the full 18 months of the study&#xD;
&#xD;
          -  Normal non-verbal cognitive abilities&#xD;
&#xD;
          -  Receptive and expressive language delay:&#xD;
&#xD;
          -  English as the only language spoken to the child in the home&#xD;
&#xD;
          -  Provision of signed and dated informed consent form&#xD;
&#xD;
          -  Attempts to imitate 10 words&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a neurodevelopmental disability other than DLD (e.g., Down syndrome, ASD,&#xD;
             intellectual disability)&#xD;
&#xD;
          -  Caregiver report of a major medical condition (e.g., seizures, cancer, stroke,&#xD;
             traumatic head injury, cleft lip/palate, cerebral palsy, legally blind, any genetic&#xD;
             diagnosis associated - - Caregiver report of preterm birth (i.e., &lt; 37 weeks&#xD;
             gestation)&#xD;
&#xD;
          -  Caregiver report of hearing impairment or audiological testing indicating hearing&#xD;
             thresholds &gt; 20dB&#xD;
&#xD;
          -  Caregiver report or direct observation of any problems chewing, sucking through a&#xD;
             straw, or blowing bubbles.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>27 Months</minimum_age>
    <maximum_age>31 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan Y Roberts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pamela Hadley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Urbana-Champaign</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ann Kaiser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Megan Roberts</investigator_full_name>
    <investigator_title>Jane Steiner Hoffman and Michael Hoffman Assistant Professor of Communication Sciences and Disorders</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Language Disorders</mesh_term>
    <mesh_term>Language Development Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Transcripts from caregiver-child and examiner-child language samples will also be donated to the Child Language Data Exchange System (http://childes.psy.cmu.edu), an international repository of child language data. Access to the data will be openly available. Researchers who access the transcripts will be expected to abide by the established guidelines for use of TalkBank data http://talkbank.org/share/irb/options.html.</ipd_description>
    <ipd_access_criteria>Data and associated documentation available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant; (2) to secure the data using appropriate computer technology; (3) to destroy or return the data after analyses are completed; and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications.</ipd_access_criteria>
  </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>August 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03782493/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/NCT03782493
org study id: U0046320
nct id: NCT03782493
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu
      Teaching-Sentence Focus (EMT-SF) intervention, implemented by caregivers and
      interventionists, relative to a control condition enrolling 108 30-month-old children and
      their caregivers. The central hypothesis is that intervention will result in better overall
      child language skills at 49 months of age.
A multi-site, phase 2, randomized clinical trial will be used to determine whether
      communication support strategies are effective for improving language outcomes in children
      with emergent developmental language disorder.

      At study entry, 108 children with emergent developmental language disorder (DLD) at 30 months
      of age will be randomly assigned 1:1 to either the EMT-SF treatment condition or a Business
      as Usual (BAU) control group. The control group is necessary to determine the efficacy of the
      EMT-SF intervention. The EMT-SF group is necessary to evaluate the effects of systematically
      teaching caregivers to use these strategies. Because all children in the study have language
      delays that will make them eligible to receive the early intervention services through the
      state early intervention program, children in both experimental conditions will receive
      state-provided community-based intervention according to their Individualized Family Service
      Plan - the current standard of care or from private speech language therapy providers.
      Children in the EMT-SF condition will receive an additional 18 months of interventionist plus
      caregiver-implemented intervention sessions. Children in both groups will be assessed at the
      start of the study and every 3 months until the child is 49 months old. The goal is to enroll
      all children at 30 months of age and provide a minimum of 60 of the planned 66 sessions of
      intervention to each child in the treatment condition; however, variability in age at study
      entry (e.g., 30 months), intervention dosage, and number of assessment data points will be
      addressed in the statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A stratified randomized clinical trial design will be used with site (Vanderbilt, Northwestern) and biological sex (boys, girls) as stratification factors and EMT-SF or business-as-usual (BAU) control as a randomization factor.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcomes assessors and data coders will be blind to experimental condition
measure: Clinical Evaluation of Language Fundamentals Preschool - 2nd edition (CELF-P2)
time frame: 49 months
description: CELF-P2 core language score at 49 months. The core language score includes summing the scaled scores from the following subtests: Word Structure (raw score min = 0; max = 24), Sentence Structure (raw score min = 0; max = 22), and Expressive Vocabulary (raw score mix = 0; max = 40), and deriving a standardized composite score (min = 45; max = 155). These three subtests provide the best diagnostic accuracy between children with and without developmental language disorders. Thus, the Core Language Score is considered the most representative reflection of a child's overall language skills. Higher standard scores represent better language outcomes.
measure: Change in number of different spoken words from a Language Sample
time frame: Change between 30 to 49 months (measured every 3 months)
description: Slope of total number of different spoken word (NDW) roots from a Language Sample measured every 3 months from 30 to 49 months derived from a 20-minute language sample. Higher scores represent better language outcomes.
measure: Change in a latent factor of grammar from a Language Sample
time frame: Change between 30 to 49 months (measured every 3 months)
description: Change in a latent variable of number of different verbs, number of different subjects, tense/agreement productivity, index of productive syntax, clauses per utterance derived from a 20-minute language sample. Higher scores represent better language outcomes.
measure: Peabody Picture Vocabulary Test - 5th Edition (PPVT-5)
time frame: 36 months
description: PPVT standard score (min = 20, max = 160). Higher scores represent better outcomes.
measure: Expressive Vocabulary Test - 3rd edition (EVT-3)
time frame: 36 months
description: Expressive Vocabulary Test (EVT-3) standard score (min = 20; max = 160). Higher scores represent better outcomes.
measure: Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2)
time frame: 42 months
description: Structured Photographic Expressive Language Test (SPELT P-2) raw score (min = 0; max = 40). Higher scores represent better outcomes.
measure: Structured Photographic Expressive Language Test - Preschool 2nd edition (SPELT-P2)
time frame: 49 months
description: Structured Photographic Expressive Language Test (SPELT P-2) raw score (min = 0; max = 40). Higher scores represent better outcomes.
measure: Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI)
time frame: 42 months
description: Test of Early Grammatical Impairment (TEGI) raw score for subscales: Third Person Singular Probe subscale (min = 0; max = 10) and the Past Tense Probe subscale (min = 0; max = 18). Higher scores represent better outcomes.
measure: Test of Early Grammatical Impairment - 3rd person singular & past tense probes (TEGI)
time frame: 49 months
description: Test of Early Grammatical Impairment (TEGI) raw score for subscales: Third Person Singular Probe subscale (min = 0; max = 10) and the Past Tense Probe subscale (min = 0; max = 18). Higher scores represent better outcomes.
measure: Focus on the Outcomes of Children Under Six (FOCUS)
time frame: 49 months
description: Focus on the Outcomes of Children Under Six (FOCUS) total raw score (min = 0, max = 350). Higher scores represent better outcomes.
measure: Decontextualized language from a Language Sample
time frame: 49 months
description: Total number of utterances that contain decontextualized language from a 20-minute Language Sample. Higher scores represent better language outcomes.
measure: Renfrew Bus Story - North American Edition (RBS-NA)
time frame: 49 months
description: Information score (min = 0; max = 52) from the Renfrew Bus Story. Higher scores represent better outcomes.
measure: Child Behavior Checklist (CBCL)
time frame: 49 months
description: Child Behavior Checklist Internalizing T score (min = 29; max = 100). Lower scores represent better outcomes.
arm group label: Enhanced Milieu Teaching-Sentence Focus
arm group type: Experimental
description: The study intervention is a behavioral intervention which will include individually teaching caregivers to use the intervention strategies from the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention using a manualized protocol (Teach-Model-Coach-Review). Caregivers will participate in 66 intervention sessions across 18 months, targeting vocabulary and grammar as well as the transition to decontextualized language.
arm group label: Business-as-usual control
arm group type: No Intervention
description: Caregivers in the control group will participate in community-based intervention services and receive the same printed intervention instructions, books, and toys at the same intervals as the treatment group, but will not receive EMT-SF intervention.
intervention type: Behavioral
intervention name: the Enhanced Milieu Teaching-Sentence Focus
description: Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
arm group label: Enhanced Milieu Teaching-Sentence Focus
other name: EMT-SF
criteria: 
gender: All
minimum age: 27 Months
maximum age: 31 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Megan Y Roberts, PhD
role: Principal Investigator
affiliation: Northwestern University
last name: Pamela Hadley, PhD
role: Principal Investigator
affiliation: University of Illinois at Urbana-Champaign
last name: Ann Kaiser, PhD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Megan Roberts
investigator title: Jane Steiner Hoffman and Michael Hoffman Assistant Professor of Communication Sciences and Disorders
mesh term: Language Disorders
mesh term: Language Development Disorders
sharing ipd: Yes
ipd description: Transcripts from caregiver-child and examiner-child language samples will also be donated to the Child Language Data Exchange System (http://childes.psy.cmu.edu), an international repository of child language data. Access to the data will be openly available. Researchers who access the transcripts will be expected to abide by the established guidelines for use of TalkBank data http://talkbank.org/share/irb/options.html.
ipd access criteria: Data and associated documentation available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant; (2) to secure the data using appropriate computer technology; (3) to destroy or return the data after analyses are completed; and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications.
provided document: 