xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05977075</url>
    </required_header>
    <id_info>
      <org_study_id>CNR-IRIB-PRO-2023-003</org_study_id>
      <nct_id>NCT05977075</nct_id>
    </id_info>
    <brief_title>Group Intervention on Executive Function in Children With Autism Spectrum Disorder</brief_title>
    <official_title>Training &quot;Unstuck and On Target! Second Edition&quot; Versus Training &quot;ApisMela&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto per la Ricerca e l'Innovazione Biomedica</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fondazione di Comunità di Messina onlus</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Istituto per la Ricerca e l'Innovazione Biomedica</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Autism is a developmental disorder characterized by difficulties in social communication,&#xD;
        repetitive behaviors, and social interaction. A key aspect of autism concerns executive&#xD;
        functions, which are a set of cognitive processes that regulate attention, planning,&#xD;
        inhibition, and impulse control. These functions are often impaired in children with autism,&#xD;
        affecting their learning and daily functioning.&#xD;
  &#xD;
        The present protocol aims to test the first absolute and then comparative effectiveness of&#xD;
        two executive function development programs: the &quot;APISMELA&quot; training and the &quot;UNSTUCK &amp; ON&#xD;
        TARGET! SECOND EDITION&quot;. Two groups will be held at the same time and will conduct the two&#xD;
        programs in reverse order. In fact, the protocol is divided into two phases.&#xD;
  &#xD;
        Participants subjected to the APISMELA group, finished the intervention sessions will conduct&#xD;
        an interim evaluation and then begin the intervention phases of the UNSTUCK &amp; ON TARGET!&#xD;
        SECOND EDITION protocol.&#xD;
  &#xD;
        Participants subjected to the UNSTUCK &amp; ON TARGET! SECOND EDITION group, finished the&#xD;
        intervention sessions will conduct an interim evaluation and then begin the intervention&#xD;
        phases of the APISMELA protocol.&#xD;
  &#xD;
        Group intervention programs were chosen for two reasons: group intervention compared with&#xD;
        individual intervention have lower costs for patients and their families and thus higher&#xD;
        overall social acceptability. The second is that group intervention within the&#xD;
        social-constructivist paradigm, to which the two chosen programs belong, becomes a&#xD;
        fundamental resource for stimulating that augmentative learning that is a source of&#xD;
        development on the cognitive and conceptual levels for human beings.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)</measure>
      <time_frame>The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete.</time_frame>
      <description>Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.&#xD;
  The WISC-IV scales are as follows:&#xD;
  index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in NEuroPSYcology second edition (NEPSY-II) evaluations</measure>
      <time_frame>The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion,about 1 year (T2).The T1 and T2 evaluations were conducted to determine whether the protocols carried out made a change.The test needs about 120-180 minutes.</time_frame>
      <description>NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age.&#xD;
  Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min &lt;2% - max &gt;75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <condition>Autism</condition>
    <arm_group>
      <arm_group_label>&quot;ApisMela/Unstuck&quot; Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Six children belonging to the experimental group. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Being a crossover clinical trial, the group ending with the ApisMela protocol continues with the Ustuck protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>&quot;Unstuck/ApisMela&quot; Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Six children belonging to the experimental group. Unstuck protocol teaches people to be more flexible, skillful in planning and goal-oriented. Being a crossover clinical trial, the group ending with the Unstuck protocol continues with the ApisMela protocol.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ApisMela protocol</intervention_name>
      <description>The activities and games proposed by this protocol are offered in a sequence characterized by increasing complexity. The same function is stimulated with varied tasks because the repetitiveness of the same task negatively affects skill generalization. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Language plays a crucial role, participants are encouraged to use speech as a tool for attention regulation and cognitive processing. It's divided into 20 sessions: a weekly group meeting of one hour and thirty.</description>
      <arm_group_label>&quot;ApisMela/Unstuck&quot; Group</arm_group_label>
      <arm_group_label>&quot;Unstuck/ApisMela&quot; Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>&quot;Unstuck and on Target&quot; protocol</intervention_name>
      <description>The protocol teaches people to be more flexible, skillful in planning and goal-oriented. It is useful for moving more easily from one topic to another and from one task to another, considering new ideas or another person's point of view, generalizing skills learned across contexts so that teachers, parents and therapists can focus more on educational aspects and less on behavioral management. It is divided into 20 sessions: a weekly group meeting of one hour and thirty minutes. A homework sheet is provided for each session to consolidate the skill learned and generalize it outside the work setting. Parents have an active role in performing the task.</description>
      <arm_group_label>&quot;ApisMela/Unstuck&quot; Group</arm_group_label>
      <arm_group_label>&quot;Unstuck/ApisMela&quot; Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children with diagnosis of autism and autism spectrum disorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of other medical disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Flavia Marino</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Flavia Marino</last_name>
      <phone>+393395798263</phone>
      <email>flavia.marino@irib.cnr.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Giovanni Pioggia</last_name>
      <phone>+393203390892</phone>
      <email>giovanni.pioggia@irib.cnr.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)</name>
        <address>
          <city>Messina</city>
          <zip>98164</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Flavia Marino</last_name>
        <email>flavia.marino@irib.cnr.it</email>
      </contact>
      <contact_backup>
        <last_name>Giovanni Pioggia</last_name>
        <email>giovanni.pioggia@irib.cnr.it</email>
      </contact_backup>
      <investigator>
        <last_name>Flavia Marino</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Giovanni Pioggia</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Paola Chilà</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Roberta Minutoli</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Noemi Vetrano</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Chiara Failla</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Germana Doria</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ileana Scarcella</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Serena Previti</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Chiara Rando</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>David Vagni</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marco Cadavero</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Roberta Torrisi</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Nydén, A., Gillberg, C., Hjelmquist, E., &amp; Heiman, M. (1999). Executive function/attention deficits in boys with Asperger syndrome, attention disorder and reading/writing disorder. Autism, 3(3), 213-228.</citation>
    </reference>
    <reference>
      <citation>Jolles DD, Crone EA. Training the developing brain: a neurocognitive perspective. Front Hum Neurosci. 2012 Apr 9;6:76. doi: 10.3389/fnhum.2012.00076. eCollection 2012.</citation>
      <PMID>22509161</PMID>
    </reference>
    <reference>
      <citation>American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.</citation>
    </reference>
    <reference>
      <citation>Wilson TD, Reinhard DA, Westgate EC, Gilbert DT, Ellerbeck N, Hahn C, Brown CL, Shaked A. Social psychology. Just think: the challenges of the disengaged mind. Science. 2014 Jul 4;345(6192):75-7. doi: 10.1126/science.1250830.</citation>
      <PMID>24994650</PMID>
    </reference>
    <reference>
      <citation>Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.</citation>
      <PMID>24256459</PMID>
    </reference>
    <reference>
      <citation>Orsolini, Margherita &amp; Melogno, Sergio &amp; Santese, Angela &amp; Toma, Chiara &amp; Latini, Nausica &amp; Salomone, Samantha &amp; Andreagiovanni, Jacopo. (2019). &quot;Pensando si Impara&quot; STIMOLARE L'ATTENZIONE, LE FUNZIONI ESECUTIVE E LA MEMORIA DI LAVORO NEI BAMBINI CON BISOGNI EDUCATIVI SPECIALI.</citation>
    </reference>
    <reference>
      <citation>Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.</citation>
      <PMID>32699642</PMID>
    </reference>
    <reference>
      <citation>Cannon J, O'Brien AM, Bungert L, Sinha P. Prediction in Autism Spectrum Disorder: A Systematic Review of Empirical Evidence. Autism Res. 2021 Apr;14(4):604-630. doi: 10.1002/aur.2482. Epub 2021 Feb 11.</citation>
      <PMID>33570249</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istituto per la Ricerca e l'Innovazione Biomedica</investigator_affiliation>
      <investigator_full_name>Flavia Marino</investigator_full_name>
      <investigator_title>Head of Unit</investigator_title>
    </responsible_party>
    <keyword>autism</keyword>
    <keyword>children</keyword>
    <keyword>executive functions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05977075
  org study id: CNR-IRIB-PRO-2023-003
  nct id: NCT05977075
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Autism is a developmental disorder characterized by difficulties in social communication,
        repetitive behaviors, and social interaction. A key aspect of autism concerns executive
        functions, which are a set of cognitive processes that regulate attention, planning,
        inhibition, and impulse control. These functions are often impaired in children with autism,
        affecting their learning and daily functioning.
  
        The present protocol aims to test the first absolute and then comparative effectiveness of
        two executive function development programs: the "APISMELA" training and the "UNSTUCK & ON
        TARGET! SECOND EDITION". Two groups will be held at the same time and will conduct the two
        programs in reverse order. In fact, the protocol is divided into two phases.
  
        Participants subjected to the APISMELA group, finished the intervention sessions will conduct
        an interim evaluation and then begin the intervention phases of the UNSTUCK & ON TARGET!
        SECOND EDITION protocol.
  
        Participants subjected to the UNSTUCK & ON TARGET! SECOND EDITION group, finished the
        intervention sessions will conduct an interim evaluation and then begin the intervention
        phases of the APISMELA protocol.
  
        Group intervention programs were chosen for two reasons: group intervention compared with
        individual intervention have lower costs for patients and their families and thus higher
        overall social acceptability. The second is that group intervention within the
        social-constructivist paradigm, to which the two chosen programs belong, becomes a
        fundamental resource for stimulating that augmentative learning that is a source of
        development on the cognitive and conceptual levels for human beings.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
  time frame: The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete.
  description: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
  The WISC-IV scales are as follows:
  index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.
  measure: Changes in NEuroPSYcology second edition (NEPSY-II) evaluations
  time frame: The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion,about 1 year (T2).The T1 and T2 evaluations were conducted to determine whether the protocols carried out made a change.The test needs about 120-180 minutes.
  description: NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age.
  Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance.
  arm group label: "ApisMela/Unstuck" Group
  arm group type: Experimental
  description: Six children belonging to the experimental group. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Being a crossover clinical trial, the group ending with the ApisMela protocol continues with the Ustuck protocol.
  arm group label: "Unstuck/ApisMela" Group
  arm group type: Experimental
  description: Six children belonging to the experimental group. Unstuck protocol teaches people to be more flexible, skillful in planning and goal-oriented. Being a crossover clinical trial, the group ending with the Unstuck protocol continues with the ApisMela protocol.
  intervention type: Other
  intervention name: ApisMela protocol
  description: The activities and games proposed by this protocol are offered in a sequence characterized by increasing complexity. The same function is stimulated with varied tasks because the repetitiveness of the same task negatively affects skill generalization. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Language plays a crucial role, participants are encouraged to use speech as a tool for attention regulation and cognitive processing. It's divided into 20 sessions: a weekly group meeting of one hour and thirty.
  arm group label: "ApisMela/Unstuck" Group
  arm group label: "Unstuck/ApisMela" Group
  intervention type: Other
  intervention name: "Unstuck and on Target" protocol
  description: The protocol teaches people to be more flexible, skillful in planning and goal-oriented. It is useful for moving more easily from one topic to another and from one task to another, considering new ideas or another person's point of view, generalizing skills learned across contexts so that teachers, parents and therapists can focus more on educational aspects and less on behavioral management. It is divided into 20 sessions: a weekly group meeting of one hour and thirty minutes. A homework sheet is provided for each session to consolidate the skill learned and generalize it outside the work setting. Parents have an active role in performing the task.
  arm group label: "ApisMela/Unstuck" Group
  arm group label: "Unstuck/ApisMela" Group
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 13 Years
  healthy volunteers: No
  last name: Flavia Marino
  role: Principal Investigator
  affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
  last name: Flavia Marino
  phone: +393395798263
  email: flavia.marino@irib.cnr.it
  last name: Giovanni Pioggia
  phone: +393203390892
  email: giovanni.pioggia@irib.cnr.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Italy
  citation: Nydén, A., Gillberg, C., Hjelmquist, E., & Heiman, M. (1999). Executive function/attention deficits in boys with Asperger syndrome, attention disorder and reading/writing disorder. Autism, 3(3), 213-228.
  citation: Jolles DD, Crone EA. Training the developing brain: a neurocognitive perspective. Front Hum Neurosci. 2012 Apr 9;6:76. doi: 10.3389/fnhum.2012.00076. eCollection 2012.
  PMID: 22509161
  citation: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
  citation: Wilson TD, Reinhard DA, Westgate EC, Gilbert DT, Ellerbeck N, Hahn C, Brown CL, Shaked A. Social psychology. Just think: the challenges of the disengaged mind. Science. 2014 Jul 4;345(6192):75-7. doi: 10.1126/science.1250830.
  PMID: 24994650
  citation: Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
  PMID: 24256459
  citation: Orsolini, Margherita & Melogno, Sergio & Santese, Angela & Toma, Chiara & Latini, Nausica & Salomone, Samantha & Andreagiovanni, Jacopo. (2019). "Pensando si Impara" STIMOLARE L'ATTENZIONE, LE FUNZIONI ESECUTIVE E LA MEMORIA DI LAVORO NEI BAMBINI CON BISOGNI EDUCATIVI SPECIALI.
  citation: Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.
  PMID: 32699642
  citation: Cannon J, O'Brien AM, Bungert L, Sinha P. Prediction in Autism Spectrum Disorder: A Systematic Review of Empirical Evidence. Autism Res. 2021 Apr;14(4):604-630. doi: 10.1002/aur.2482. Epub 2021 Feb 11.
  PMID: 33570249
  responsible party type: Principal Investigator
  investigator affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
  investigator full name: Flavia Marino
  investigator title: Head of Unit
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  sharing ipd: No