<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/NCT03238677</url>
  </required_header>
  <id_info>
    <org_study_id>17-177</org_study_id>
    <secondary_id>R15DC016426</secondary_id>
    <nct_id>NCT03238677</nct_id>
  </id_info>
  <brief_title>Treating Childhood Apraxia of Speech</brief_title>
  <official_title>Treating Childhood Apraxia of Speech: Role of Biofeedback &amp; Practice Distribution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syracuse 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>Syracuse 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will test two modifications to speech therapy for 40 school-age children with&#xD;
      childhood apraxia of speech to determine how to improve treatment outcomes. The study will&#xD;
      compare treatment that includes real-time visual feedback of the tongue during speech using&#xD;
      ultrasound vs traditional therapy that does not include ultrasound visual feedback.&#xD;
      Additionally, some children will be treated with a traditional schedule of 2 sessions per&#xD;
      week, whereas others will be provided with treatment that begins with intensive training (10&#xD;
      hours of therapy in one week) and progresses to a more distributed treatment schedule.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood apraxia of speech is a developmental speech sound disorder that may lead to&#xD;
      persisting speech errors, often despite years of treatment. Such impairments may lead to&#xD;
      social, academic, and vocational limitations. Thus, there is a need to explore alternate&#xD;
      treatment approaches. This study will explore how to improve speech sound production in&#xD;
      school-age children with CAS by modifying a standard speech therapy program. Two adaptations&#xD;
      to speech therapy will be tested in a 2 x 2 randomized group design.&#xD;
&#xD;
      In Aim 1, a standard treatment schedule of 2 one-hour sessions per week will be compared&#xD;
      against a treatment sequence beginning with an intensive therapy schedule (10 hrs of&#xD;
      treatment in one week), which will then transition to a more distributed practice schedule.&#xD;
      This treatment modification is intended to minimize erred practice between training sessions&#xD;
      in the early stages of learning, then foster generalization through increased time between&#xD;
      practice sessions.&#xD;
&#xD;
      In Aim 2, a standard treatment that includes only verbal feedback to the client during speech&#xD;
      practice will be compared against a treatment sequence that initially includes real-time&#xD;
      ultrasound visual feedback of the tongue during speech, which will be faded over the course&#xD;
      of treatment. Ultrasound visual feedback is designed to train articulatory movements. It may&#xD;
      enhance children's understanding of the articulatory goals of speech movement patterns by&#xD;
      comparing executed tongue movements with intended movements. Prior case reports and single&#xD;
      subject experimental designs have shown that speech sound production may be enhanced by&#xD;
      including ultrasound visual feedback, although no prior randomized group studies have been&#xD;
      conducted.&#xD;
&#xD;
      Beside these modifications, the other aspects of treatment will be held constant. Outcomes&#xD;
      will be evaluated by tracking changes in percent consonants correct from a large speech&#xD;
      sample, scored by individuals who are blind to treatment status. The four groups will be&#xD;
      compared to determine the extent to which speech sound therapy can be enhanced through a&#xD;
      treatment sequence that begins with intensive practice and/or with ultrasound visual&#xD;
      feedback.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 7, 2022</completion_date>
  <primary_completion_date type="Actual">May 9, 2022</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>Factorial Assignment</intervention_model>
    <intervention_model_description>2 x 2 design Scheduling: Mass--&gt;Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Individuals who conduct the phonetic transcriptions that will be used for the primary outcome data will be blinded as to whether the recordings were collected before or after treatment, and also blinded as to the group assignment of the participant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Speech Sound Accuracy</measure>
    <time_frame>10 weeks from the start of treatment</time_frame>
    <description>Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, &quot;leave the location&quot;), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund &amp; Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Childhood Apraxia of Speech</condition>
  <arm_group>
    <arm_group_label>Biofeedback, Massed-&gt;Distributed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequenced biofeedback Mass Practice--&gt; Distributed Scheduling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Biofeedback, Distributed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofeedback, Distributed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequenced biofeedback, 2 sessions/wk for 10 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Biofeedback, Massed-&gt; Distributed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speech Motor Chaining without Biofeedback</intervention_name>
    <description>These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html</description>
    <arm_group_label>No Biofeedback, Distributed</arm_group_label>
    <arm_group_label>No Biofeedback, Massed-&gt; Distributed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Biofeedback</intervention_name>
    <description>Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.</description>
    <arm_group_label>Biofeedback, Distributed</arm_group_label>
    <arm_group_label>Biofeedback, Massed-&gt;Distributed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Distributed Practice</intervention_name>
    <description>2 sessions per week for 10 weeks</description>
    <arm_group_label>Biofeedback, Distributed</arm_group_label>
    <arm_group_label>No Biofeedback, Distributed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Massed --&gt; Distributed Practice</intervention_name>
    <description>Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment</description>
    <arm_group_label>Biofeedback, Massed-&gt;Distributed</arm_group_label>
    <arm_group_label>No Biofeedback, Massed-&gt; Distributed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Native English speakers who hear English as the dominant language in their home&#xD;
             setting.&#xD;
&#xD;
          -  Must pass a hearing screening.&#xD;
&#xD;
          -  Score at or better than -2 standard deviations from the mean on the Matrix Reasoning&#xD;
             Task of the Wechsler Abbreviated Scale of Intelligence - 2nd Edition (WASI-2; t-score&#xD;
             ≥ 30), Peabody Picture Vocabulary Test - 4th Edition (PPVT-4; standard score ≥ 70),&#xD;
             and the Following Directions subtest of the Clinical Evaluation of Language&#xD;
             Fundamentals - 5th Edition (CELF-5; scaled score ≥ 3).&#xD;
&#xD;
          -  Goldman-Fristoe Test of Articulation - 3rd Edition (GFTA-3) percentile ≤ 5th).&#xD;
&#xD;
          -  A diagnosis of CAS will be verified based on a polysyllable picture naming task,&#xD;
             diadochokinetic task (puh-tuh-kuh), and syllable repetition task.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent report or direct evaluation reveals oral-facial structural abnormalities (e.g.,&#xD;
             cleft palate).&#xD;
&#xD;
          -  Parental report of neurobehavioral disorders (e.g., autism spectrum disorders, ADHD,&#xD;
             obsessive-compulsive disorder), or vision problems that are corrected with&#xD;
             glasses/contacts.&#xD;
&#xD;
          -  Fail a hearing screening, or failure to meet criteria listed above as Inclusionary&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Syracuse University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://speechproductionlab.syr.edu/Resources.html</url>
    <description>Speech Motor Chaining Procedural manual</description>
  </link>
  <reference>
    <citation>Preston JL, Leece MC, Maas E. Intensive Treatment with Ultrasound Visual Feedback for Speech Sound Errors in Childhood Apraxia. Front Hum Neurosci. 2016 Aug 30;10:440. doi: 10.3389/fnhum.2016.00440. eCollection 2016.</citation>
    <PMID>27625603</PMID>
  </reference>
  <reference>
    <citation>Preston JL, Leece MC, McNamara K, Maas E. Variable Practice to Enhance Speech Learning in Ultrasound Biofeedback Treatment for Childhood Apraxia of Speech: A Single Case Experimental Study. Am J Speech Lang Pathol. 2017 Aug 15;26(3):840-852. doi: 10.1044/2017_AJSLP-16-0155.</citation>
    <PMID>28715554</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>April 19, 2023</results_first_submitted>
  <results_first_submitted_qc>May 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2023</results_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Syracuse University</investigator_affiliation>
    <investigator_full_name>Jonathan Preston</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>speech sound disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apraxias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03238677/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 13, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03238677/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Biofeedback, Massed-&gt;Distributed, Face-to-Face</title>
          <description>Sequenced biofeedback Mass Practice--&gt; Distributed Scheduling&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="P2">
          <title>No Biofeedback, Distributed, Face-to-Face</title>
          <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="P3">
          <title>Biofeedback, Distributed, Face-to-Face</title>
          <description>Sequenced biofeedback, 2 sessions/wk for 10 weeks&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="P4">
          <title>No Biofeedback, Massed-&gt; Distributed, Face-to-Face</title>
          <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="P5">
          <title>No Biofeeedback, Distributed, Telepractice</title>
          <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Telepractice</description>
        </group>
        <group group_id="P6">
          <title>No Biofeedback, Massed-&gt;Distributed, Telepractice</title>
          <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Telepractice</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Biofeedback, Massed-&gt;Distributed, Face-to-Face</title>
          <description>Sequenced biofeedback Mass Practice--&gt; Distributed Scheduling&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="B2">
          <title>No Biofeedback, Distributed, Face-to-Face</title>
          <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="B3">
          <title>Biofeedback, Distributed, Face-to-Face</title>
          <description>Sequenced biofeedback, 2 sessions/wk for 10 weeks&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="B4">
          <title>No Biofeedback, Massed-&gt; Distributed, Face-to-Face</title>
          <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="B5">
          <title>No Biofeeedback, Distributed, Telepractice</title>
          <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Telepractice</description>
        </group>
        <group group_id="B6">
          <title>No Biofeedback, Massed-&gt;Distributed, Telepractice</title>
          <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Telepractice</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="9"/>
            <count group_id="B7" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="9"/>
                    <count group_id="B5" value="10"/>
                    <count group_id="B6" value="9"/>
                    <count group_id="B7" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.31" spread="1.0"/>
                    <measurement group_id="B2" value="10.85" spread="1.7"/>
                    <measurement group_id="B3" value="12.2" spread="2.1"/>
                    <measurement group_id="B4" value="10.0" spread="1.1"/>
                    <measurement group_id="B5" value="11.05" spread="2.4"/>
                    <measurement group_id="B6" value="11.16" spread="2.3"/>
                    <measurement group_id="B7" value="10.96" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="9"/>
                    <count group_id="B5" value="10"/>
                    <count group_id="B6" value="9"/>
                    <count group_id="B7" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="9"/>
                    <count group_id="B5" value="10"/>
                    <count group_id="B6" value="9"/>
                    <count group_id="B7" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="9"/>
                    <count group_id="B5" value="10"/>
                    <count group_id="B6" value="9"/>
                    <count group_id="B7" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="9"/>
                    <count group_id="B5" value="10"/>
                    <count group_id="B6" value="9"/>
                    <count group_id="B7" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Speech Sound Accuracy</title>
          <description>The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, &quot;leave the location&quot;), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund &amp; Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.</description>
          <population>Participant withdrew after randomization but before baseline collection of this datapoint</population>
          <units>Percent correct</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="8"/>
                    <count group_id="B5" value="10"/>
                    <count group_id="B6" value="9"/>
                    <count group_id="B7" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.2" spread="7.3"/>
                    <measurement group_id="B2" value="21.2" spread="12.1"/>
                    <measurement group_id="B3" value="17.0" spread="4.3"/>
                    <measurement group_id="B4" value="23.2" spread="7.4"/>
                    <measurement group_id="B5" value="28.9" spread="8.1"/>
                    <measurement group_id="B6" value="35.5" spread="7.8"/>
                    <measurement group_id="B7" value="24.3" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Speech Sound Accuracy</title>
        <description>Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, &quot;leave the location&quot;), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund &amp; Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.</description>
        <time_frame>10 weeks from the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback, Massed-&gt;Distributed, Face-to-Face</title>
            <description>Sequenced biofeedback Mass Practice--&gt; Distributed Scheduling&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
          </group>
          <group group_id="O2">
            <title>No Biofeedback, Distributed, Face-to-Face</title>
            <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
          </group>
          <group group_id="O3">
            <title>Biofeedback, Distributed, Face-to-Face</title>
            <description>Sequenced biofeedback, 2 sessions/wk for 10 weeks&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
          </group>
          <group group_id="O4">
            <title>No Biofeedback, Massed-&gt; Distributed, Face-to-Face</title>
            <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
          </group>
          <group group_id="O5">
            <title>No Biofeeedback, Distributed, Telepractice</title>
            <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Telepractice</description>
          </group>
          <group group_id="O6">
            <title>No Biofeedback, Massed-&gt;Distributed, Telepractice</title>
            <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Telepractice</description>
          </group>
        </group_list>
        <measure>
          <title>Speech Sound Accuracy</title>
          <description>Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, &quot;leave the location&quot;), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund &amp; Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.</description>
          <units>Percent correct</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.1" spread="13.5"/>
                    <measurement group_id="O2" value="32.5" spread="14.1"/>
                    <measurement group_id="O3" value="26.8" spread="10.2"/>
                    <measurement group_id="O4" value="42.1" spread="11.1"/>
                    <measurement group_id="O5" value="32.50" spread="7.0"/>
                    <measurement group_id="O6" value="43.0" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Main effect of biofeedback at 10 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.132</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.2</ci_lower_limit>
            <ci_upper_limit>3.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Main effect of Practice Distribution at 10 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.028</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-13.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.9</ci_lower_limit>
            <ci_upper_limit>-1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Main effect comparing telepractice vs face-to-face treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.187</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.9</ci_lower_limit>
            <ci_upper_limit>5.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Interaction of biofeedback and practice distribution at 10 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.125</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>20.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.8</ci_lower_limit>
            <ci_upper_limit>46.3</ci_upper_limit>
            <other_analysis_desc>η2 =.054</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 weeks and 10 weeks after the start of treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Biofeedback, Massed-&gt;Distributed, Face-to-Face</title>
          <description>Sequenced biofeedback Mass Practice--&gt; Distributed Scheduling&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="E2">
          <title>No Biofeedback, Distributed, Face-to-Face</title>
          <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="E3">
          <title>Biofeedback, Distributed, Face-to-Face</title>
          <description>Sequenced biofeedback, 2 sessions/wk for 10 weeks&#xD;
Biofeedback: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="E4">
          <title>No Biofeedback, Massed-&gt; Distributed, Face-to-Face</title>
          <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Face-to-Face</description>
        </group>
        <group group_id="E5">
          <title>No Biofeeedback, Distributed, Telepractice</title>
          <description>Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level.&#xD;
Distributed Practice: 2 sessions per week for 10 weeks&#xD;
Modality: Telepractice</description>
        </group>
        <group group_id="E6">
          <title>No Biofeedback, Massed-&gt;Distributed, Telepractice</title>
          <description>Speech Motor Chaining with no biofeedback. Mass Practice--&gt; Distributed Scheduling&#xD;
Speech Motor Chaining without Biofeedback: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html&#xD;
Massed --&gt; Distributed Practice: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment&#xD;
Modality: Telepractice</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The interruptions due to the COVID-19 pandemic resulted an imbalance in participants in the Ultrasound vs No Ultrasound conditions, which limits statistical power. Participants were not randomized to telepractice vs face-to-face.&#xD;
Also, the treatment emphasizes speech sound accuracy. There is not a direct focus on teaching other features such as lexical stress. Other approaches, such as Rapid Syllable Transition Training would be more appropriate to address other elements of speech production.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jonathan Preston</name_or_title>
      <organization>Syracuse University</organization>
      <phone>3154433143</phone>
      <email>jopresto@syr.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03238677
org study id: 17-177
secondary id: R15DC016426
nct id: NCT03238677
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study will test two modifications to speech therapy for 40 school-age children with
      childhood apraxia of speech to determine how to improve treatment outcomes. The study will
      compare treatment that includes real-time visual feedback of the tongue during speech using
      ultrasound vs traditional therapy that does not include ultrasound visual feedback.
      Additionally, some children will be treated with a traditional schedule of 2 sessions per
      week, whereas others will be provided with treatment that begins with intensive training (10
      hours of therapy in one week) and progresses to a more distributed treatment schedule.
Childhood apraxia of speech is a developmental speech sound disorder that may lead to
      persisting speech errors, often despite years of treatment. Such impairments may lead to
      social, academic, and vocational limitations. Thus, there is a need to explore alternate
      treatment approaches. This study will explore how to improve speech sound production in
      school-age children with CAS by modifying a standard speech therapy program. Two adaptations
      to speech therapy will be tested in a 2 x 2 randomized group design.

      In Aim 1, a standard treatment schedule of 2 one-hour sessions per week will be compared
      against a treatment sequence beginning with an intensive therapy schedule (10 hrs of
      treatment in one week), which will then transition to a more distributed practice schedule.
      This treatment modification is intended to minimize erred practice between training sessions
      in the early stages of learning, then foster generalization through increased time between
      practice sessions.

      In Aim 2, a standard treatment that includes only verbal feedback to the client during speech
      practice will be compared against a treatment sequence that initially includes real-time
      ultrasound visual feedback of the tongue during speech, which will be faded over the course
      of treatment. Ultrasound visual feedback is designed to train articulatory movements. It may
      enhance children's understanding of the articulatory goals of speech movement patterns by
      comparing executed tongue movements with intended movements. Prior case reports and single
      subject experimental designs have shown that speech sound production may be enhanced by
      including ultrasound visual feedback, although no prior randomized group studies have been
      conducted.

      Beside these modifications, the other aspects of treatment will be held constant. Outcomes
      will be evaluated by tracking changes in percent consonants correct from a large speech
      sample, scored by individuals who are blind to treatment status. The four groups will be
      compared to determine the extent to which speech sound therapy can be enhanced through a
      treatment sequence that begins with intensive practice and/or with ultrasound visual
      feedback.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: 2 x 2 design Scheduling: Mass-->Distributed vs. Distributed only Visual feedback: Sequenced Ultrasound Biofeedback vs. No biofeedback
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Individuals who conduct the phonetic transcriptions that will be used for the primary outcome data will be blinded as to whether the recordings were collected before or after treatment, and also blinded as to the group assignment of the participant.
measure: Speech Sound Accuracy
time frame: 10 weeks from the start of treatment
description: Percent consonants correct for target sounds: The primary outcome measure was percent correct for each participant's target sound-positions in untreated phrase. Participants imitated 20 pre-recorded phrases, each containing the target sound pattern 2 times per stimulus (e.g., for /l/ onset, "leave the location"), resulting in 40 attempts at each sound-position. For each session, 3 transcribers independently transcribed in Phon software (Hedlund & Rose, 2022) and accuracy was averaged across transcribers. Instances where IPA symbols for the Actual transcription differed from the Target transcription was scored as incorrect.
arm group label: Biofeedback, Massed->Distributed
arm group type: Experimental
description: Sequenced biofeedback Mass Practice--> Distributed Scheduling
arm group label: No Biofeedback, Distributed
arm group type: Active Comparator
description: Speech Motor Chaining with no biofeedback. 2 sessions/wk for 10 weeks
arm group label: Biofeedback, Distributed
arm group type: Experimental
description: Sequenced biofeedback, 2 sessions/wk for 10 weeks
arm group label: No Biofeedback, Massed-> Distributed
arm group type: Experimental
description: Speech Motor Chaining with no biofeedback. Mass Practice--> Distributed Scheduling
intervention type: Behavioral
intervention name: Speech Motor Chaining without Biofeedback
description: These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html
arm group label: No Biofeedback, Distributed
arm group label: No Biofeedback, Massed-> Distributed
intervention type: Behavioral
intervention name: Biofeedback
description: Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.
arm group label: Biofeedback, Distributed
arm group label: Biofeedback, Massed->Distributed
intervention type: Behavioral
intervention name: Distributed Practice
description: 2 sessions per week for 10 weeks
arm group label: Biofeedback, Distributed
arm group label: No Biofeedback, Distributed
intervention type: Behavioral
intervention name: Massed --> Distributed Practice
description: Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment
arm group label: Biofeedback, Massed->Distributed
arm group label: No Biofeedback, Massed-> Distributed
criteria: 
gender: All
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
url: http://speechproductionlab.syr.edu/Resources.html
description: Speech Motor Chaining Procedural manual
citation: Preston JL, Leece MC, Maas E. Intensive Treatment with Ultrasound Visual Feedback for Speech Sound Errors in Childhood Apraxia. Front Hum Neurosci. 2016 Aug 30;10:440. doi: 10.3389/fnhum.2016.00440. eCollection 2016.
PMID: 27625603
citation: Preston JL, Leece MC, McNamara K, Maas E. Variable Practice to Enhance Speech Learning in Ultrasound Biofeedback Treatment for Childhood Apraxia of Speech: A Single Case Experimental Study. Am J Speech Lang Pathol. 2017 Aug 15;26(3):840-852. doi: 10.1044/2017_AJSLP-16-0155.
PMID: 28715554
responsible party type: Principal Investigator
investigator affiliation: Syracuse University
investigator full name: Jonathan Preston
investigator title: Associate Professor
mesh term: Apraxias
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The interruptions due to the COVID-19 pandemic resulted an imbalance in participants in the Ultrasound vs No Ultrasound conditions, which limits statistical power. Participants were not randomized to telepractice vs face-to-face.
Also, the treatment emphasizes speech sound accuracy. There is not a direct focus on teaching other features such as lexical stress. Other approaches, such as Rapid Syllable Transition Training would be more appropriate to address other elements of speech production.
point of contact: 