<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/NCT02202421</url>
  </required_header>
  <id_info>
    <org_study_id>CCF IRB 14-429</org_study_id>
    <nct_id>NCT02202421</nct_id>
  </id_info>
  <brief_title>T-ABA Group Based Early Intervention For Parents of Children With ASD</brief_title>
  <acronym>T-ABA</acronym>
  <official_title>Targeted Applied Behavior Analysis (T-ABA) Group Based Early Intervention for Parents of Children With Autism Spectrum Disorder (ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>O'Neill Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CVS Caremark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy&#xD;
      of T-ABA with combined parent training and individual child sessions versus T-ABA with&#xD;
      individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a&#xD;
      form of behavior therapy used to promote skill development and reduce disruptive behavior in&#xD;
      individuals with autism. Four key outcome assessment points will be used: baseline (week 0),&#xD;
      midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving&#xD;
      T-ABA parent training only will be offered eight individual therapy sessions at the end of&#xD;
      the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up&#xD;
      assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a ten week study. The child will be randomized to one of two treatment groups.&#xD;
      Assignment is chosen by chance (like flipping a coin). The two treatment groups are T-ABA&#xD;
      (Targeted Applied Behavior Analysis) with parent training and T-ABA with parent training and&#xD;
      individual child sessions. For both groups, study procedures will be the same except the&#xD;
      T-ABA with parent training and individual child sessions group will receive eight one-to-one&#xD;
      Applied Behavior Analysis (ABA) individual therapy sessions during the course of the study.&#xD;
      Participants in the T-ABA with parent training group will be offered eight one-to-one ABA&#xD;
      individual therapy sessions at the conclusion of the study.&#xD;
&#xD;
      During the child's participation in this study families are asked to not make any changes to&#xD;
      his or her current neuropsychiatric medications or therapy for two weeks before the study&#xD;
      begins and during his or her ten week participation. Medication changes may include&#xD;
      increasing or decreasing the dose you receive, changing the time of day the child takes&#xD;
      medication, starting a new medication, or discontinuing a current medication. Therapy the&#xD;
      child receives may include speech, OT, PT, counseling, play therapy, music therapy, social&#xD;
      skills training, special education services, socialization, recreational sports, or&#xD;
      nutritional interventions. Therapy changes may include increasing or decreasing how often the&#xD;
      child receives therapy, changing who the child receives therapy from, beginning a new therapy&#xD;
      or discontinuing a current therapy.&#xD;
&#xD;
      The child will be asked to complete assessments before the start of the study. The child will&#xD;
      complete a language assessment and an eye tracking task that will measure his or her&#xD;
      attention to different pictures and videos. Families will complete questionnaires that&#xD;
      examine the child's medical and family history as well as his or her current symptoms,&#xD;
      functioning, and quality of life and families will be given a language collection device.&#xD;
      This is like a recorder that will record every time the family or the child talks. Families&#xD;
      will place the language collection device in the pocket of the child's clothing and it will&#xD;
      record the language environment for two days. Families will return the language collection&#xD;
      device to us. To help us better understand your child's medical condition, we will access the&#xD;
      child's medical records to collect any previous evaluations and diagnoses.&#xD;
&#xD;
      During weeks 1 through 4, families will attend a parent training group. Each group will be&#xD;
      1.5 hours long and will focus on topics such as discrete trial teaching (breaking skills into&#xD;
      small components in order to teach new information to the child), natural environment&#xD;
      teaching (using the environment to increase the child's motivation to communicate), assessing&#xD;
      and treating challenging behavior, using visual supports and teaching everyday living&#xD;
      activities such as drinking from a cup or washing hands. During these groups families will&#xD;
      have the opportunity to view examples and practice using the skills discussed.&#xD;
&#xD;
      During week 5, families will attend a parent training group. Families and their children will&#xD;
      also be observed and videotaped by study staff for 10 minutes during which they will be asked&#xD;
      to use the techniques you learned during the parent group. The video tape will be kept in the&#xD;
      child's study file and will only be viewed by study staff as part of the research study.&#xD;
      Families will also complete questionnaires that examine the child's medical and family&#xD;
      history as well as his or her current symptoms, functioning, and quality of life and will be&#xD;
      given a language collection device (like a tape recorder). They will place the language&#xD;
      collection device in the pocket of the child's clothing and it will record his or her&#xD;
      language and language environment for 2 days. They will return the language collection device&#xD;
      to us.&#xD;
&#xD;
      During weeks 6 through 9 families and their children will attend a one-hour weekly&#xD;
      parent-therapist session with a study staff member. They will practice using the techniques&#xD;
      from the parent group with their child and the study staff member will provide them with&#xD;
      coaching and feedback. Families can also bring along specific questions they have.&#xD;
&#xD;
      During week 10, families will attend a parent-therapist session. Families and their children&#xD;
      will also be observed and videotaped by study staff for 10 minutes during which they will&#xD;
      practice using the techniques from the parent group with their child. They will also complete&#xD;
      questionnaires that examine the child's current symptoms, functioning, and quality of life&#xD;
      and they will be given a language collection device. They will place the language collection&#xD;
      device in the pocket of the child's clothing and it will record his or her language and&#xD;
      language environment for 2 days. Families will return the language collection device to us.&#xD;
      The child will also complete testing with a study staff. Testing will measure the child's&#xD;
      language and attention to pictures and videos during an eye tracking task.&#xD;
&#xD;
      Ten weeks after the study is complete, families and their children will complete the same&#xD;
      assessment procedures that were completed during week 10 in order to measure any changes that&#xD;
      occurred after the end of the study.&#xD;
&#xD;
      If a family is in the T-ABA with parent training and individual child sessions group, the&#xD;
      child will also receive one-to-one ABA therapy sessions during weeks 1 through 4 and 6&#xD;
      through 9. During the one-to-one ABA therapy sessions the child may work with the therapist&#xD;
      on skills such as making eye contact when his or her name is called, playing with toys,&#xD;
      asking for favorite foods or activities using words or gestures, making choices, taking turns&#xD;
      or responding to one-step commands. Study staff will work with families to select programming&#xD;
      to be completed with their child during these sessions.&#xD;
&#xD;
      If a family is in the T-ABA with parent training group, they will be asked if they'd like to&#xD;
      schedule eight one-to-one ABA therapy sessions at the conclusion of the study (after&#xD;
      follow-up assessments have been collected).&#xD;
&#xD;
      Families will receive assessment results in a brief report provided after testing is&#xD;
      completed at visits 1, 5, 10 and follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI and study coordinator both left the institution.&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in child utterances</measure>
    <time_frame>10 weeks</time_frame>
    <description>The primary objective of this study is to determine whether T-ABA with parent training and individual child sessions is superior to T-ABA with parent training alone in improving child utterances as calculated by the LENA digital language processor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child communication</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in increasing the number of child utterances as measured using the LENA Pro language collection device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autism and other behavioral symptoms</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving autism and other behavioral symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Language Scores</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving language scores on cognitive testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adaptive Behavior</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving adaptive behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye Tracking</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving eye tracking of social targets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Functioning</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving global functioning via VB-MAPP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Demographics and Clinical Variables</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate whether baseline demographic and clinical variables (age, sex, IQ, parent education, parent occupation level, presence of a genetic syndrome) significantly predict patient outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent Fidelity</measure>
    <time_frame>10 weeks</time_frame>
    <description>To assess if parent fidelity of T-ABA treatment predicts greater improvement in outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Parent Education</measure>
    <time_frame>10 weeks</time_frame>
    <description>To evaluate parents' increased understanding of autism and strategies to manage their child's behavior, evaluated by a pre-/post-test regarding autism and therapeutic options.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>T-ABA Parent Training Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the T-ABA Parent Training Only group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T-ABA Parent Group + Individual Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the T-ABA Parent Group plus Individual Therapy group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Targeted Applied Behavior Analysis (T-ABA)</intervention_name>
    <description>Participants will be enrolled in a five week Targeted Applied Behavior Analysis (T-ABA) parent therapy group. T-ABA parent groups will be 1.5 hours in length. Following the five weeks of parent group sessions, parents will participate in five weekly one-hour parent-therapist sessions in which a therapist will work one-on-one with the parent and their child. One treatment group (T-ABA Parent Group plus Individual Therapy) will also receive eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. The second treatment group (T-ABA Parent Training Only) will be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired.</description>
    <arm_group_label>T-ABA Parent Group + Individual Therapy</arm_group_label>
    <arm_group_label>T-ABA Parent Training Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical DSM-5 diagnosis of Autism Spectrum Disorder (299.00).&#xD;
&#xD;
          -  Age 2.0 (24 months) to 5.99 (71 months) at time of consent.&#xD;
&#xD;
          -  If participant is using neuropsychiatric medication and/or receiving therapy (PT, OT,&#xD;
             speech, ABA, etc.), these must be stable two weeks prior to their study participation&#xD;
             and throughout the 10 week study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 2.0 (24 months) or greater than 5.99 (71 months) at time of consent.&#xD;
&#xD;
          -  Individuals for whom neuropsychiatric medication (dose, dosing schedule, introduction&#xD;
             of new medication, discontinuing current medication) or therapy (frequency of&#xD;
             intervention, provider, introduction of new therapy, discontinuing current therapy)&#xD;
             changes may occur two weeks prior to study or during the 10 week study period.&#xD;
&#xD;
          -  Any participant who has previously received Applied Behavior Analysis (ABA) therapy&#xD;
             (any form).&#xD;
&#xD;
          -  Parent and/or guardian unable to speak, read and/or understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>71 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas W Frazier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Center for Autism</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Center for Autism</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth ed. Arlington, VA: American Psychiatric Association; 2013.</citation>
  </reference>
  <reference>
    <citation>Kohler, F.W. Examining the services received by young children with autism and their families: A survey of parent responses. Focus on Autism and Other Developmental Disabilities. 1999;14:150-158.</citation>
  </reference>
  <reference>
    <citation>Stoner JB, Bock SJ, Thompson JR, Angell ME, Heyl BS, Crowley EP. Welcome to our world: Parent perceptions of interactions between parents of young children with ASD and educational professionals. Focus on Autism and Other Developmental Disabilities. 2005;20:39-51.</citation>
  </reference>
  <reference>
    <citation>Kogan MD, Strickland BB, Blumberg SJ, Singh GK, Perrin JM, van Dyck PC. A national profile of the health care experiences and family impact of autism spectrum disorder among children in the United States, 2005-2006. Pediatrics. 2008 Dec;122(6):e1149-58. doi: 10.1542/peds.2008-1057.</citation>
    <PMID>19047216</PMID>
  </reference>
  <reference>
    <citation>Minjarez MB, Williams SE, Mercier EM, Hardan AY. Pivotal response group treatment program for parents of children with autism. J Autism Dev Disord. 2011 Jan;41(1):92-101. doi: 10.1007/s10803-010-1027-6.</citation>
    <PMID>20440638</PMID>
  </reference>
  <reference>
    <citation>Coolican J, Smith IM, Bryson SE. Brief parent training in pivotal response treatment for preschoolers with autism. J Child Psychol Psychiatry. 2010 Dec;51(12):1321-30. doi: 10.1111/j.1469-7610.2010.02326.x.</citation>
    <PMID>21073457</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>October 20, 2017</last_update_submitted>
  <last_update_submitted_qc>October 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism</keyword>
  <keyword>Applied Behavior Analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02202421
org study id: CCF IRB 14-429
nct id: NCT02202421
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is a 10-week, randomized, parallel groups design which will evaluate the efficacy
      of T-ABA with combined parent training and individual child sessions versus T-ABA with
      individual sessions alone. T-ABA refers to Targeted Applied Behavior Analysis treatment, a
      form of behavior therapy used to promote skill development and reduce disruptive behavior in
      individuals with autism. Four key outcome assessment points will be used: baseline (week 0),
      midpoint (week 5), end-of-study (week 10), and follow-up (week 20). Participants receiving
      T-ABA parent training only will be offered eight individual therapy sessions at the end of
      the study. Total study participation is estimated to be ~ 10 weeks with a single follow-up
      assessment.
This is a ten week study. The child will be randomized to one of two treatment groups.
      Assignment is chosen by chance (like flipping a coin). The two treatment groups are T-ABA
      (Targeted Applied Behavior Analysis) with parent training and T-ABA with parent training and
      individual child sessions. For both groups, study procedures will be the same except the
      T-ABA with parent training and individual child sessions group will receive eight one-to-one
      Applied Behavior Analysis (ABA) individual therapy sessions during the course of the study.
      Participants in the T-ABA with parent training group will be offered eight one-to-one ABA
      individual therapy sessions at the conclusion of the study.

      During the child's participation in this study families are asked to not make any changes to
      his or her current neuropsychiatric medications or therapy for two weeks before the study
      begins and during his or her ten week participation. Medication changes may include
      increasing or decreasing the dose you receive, changing the time of day the child takes
      medication, starting a new medication, or discontinuing a current medication. Therapy the
      child receives may include speech, OT, PT, counseling, play therapy, music therapy, social
      skills training, special education services, socialization, recreational sports, or
      nutritional interventions. Therapy changes may include increasing or decreasing how often the
      child receives therapy, changing who the child receives therapy from, beginning a new therapy
      or discontinuing a current therapy.

      The child will be asked to complete assessments before the start of the study. The child will
      complete a language assessment and an eye tracking task that will measure his or her
      attention to different pictures and videos. Families will complete questionnaires that
      examine the child's medical and family history as well as his or her current symptoms,
      functioning, and quality of life and families will be given a language collection device.
      This is like a recorder that will record every time the family or the child talks. Families
      will place the language collection device in the pocket of the child's clothing and it will
      record the language environment for two days. Families will return the language collection
      device to us. To help us better understand your child's medical condition, we will access the
      child's medical records to collect any previous evaluations and diagnoses.

      During weeks 1 through 4, families will attend a parent training group. Each group will be
      1.5 hours long and will focus on topics such as discrete trial teaching (breaking skills into
      small components in order to teach new information to the child), natural environment
      teaching (using the environment to increase the child's motivation to communicate), assessing
      and treating challenging behavior, using visual supports and teaching everyday living
      activities such as drinking from a cup or washing hands. During these groups families will
      have the opportunity to view examples and practice using the skills discussed.

      During week 5, families will attend a parent training group. Families and their children will
      also be observed and videotaped by study staff for 10 minutes during which they will be asked
      to use the techniques you learned during the parent group. The video tape will be kept in the
      child's study file and will only be viewed by study staff as part of the research study.
      Families will also complete questionnaires that examine the child's medical and family
      history as well as his or her current symptoms, functioning, and quality of life and will be
      given a language collection device (like a tape recorder). They will place the language
      collection device in the pocket of the child's clothing and it will record his or her
      language and language environment for 2 days. They will return the language collection device
      to us.

      During weeks 6 through 9 families and their children will attend a one-hour weekly
      parent-therapist session with a study staff member. They will practice using the techniques
      from the parent group with their child and the study staff member will provide them with
      coaching and feedback. Families can also bring along specific questions they have.

      During week 10, families will attend a parent-therapist session. Families and their children
      will also be observed and videotaped by study staff for 10 minutes during which they will
      practice using the techniques from the parent group with their child. They will also complete
      questionnaires that examine the child's current symptoms, functioning, and quality of life
      and they will be given a language collection device. They will place the language collection
      device in the pocket of the child's clothing and it will record his or her language and
      language environment for 2 days. Families will return the language collection device to us.
      The child will also complete testing with a study staff. Testing will measure the child's
      language and attention to pictures and videos during an eye tracking task.

      Ten weeks after the study is complete, families and their children will complete the same
      assessment procedures that were completed during week 10 in order to measure any changes that
      occurred after the end of the study.

      If a family is in the T-ABA with parent training and individual child sessions group, the
      child will also receive one-to-one ABA therapy sessions during weeks 1 through 4 and 6
      through 9. During the one-to-one ABA therapy sessions the child may work with the therapist
      on skills such as making eye contact when his or her name is called, playing with toys,
      asking for favorite foods or activities using words or gestures, making choices, taking turns
      or responding to one-step commands. Study staff will work with families to select programming
      to be completed with their child during these sessions.

      If a family is in the T-ABA with parent training group, they will be asked if they'd like to
      schedule eight one-to-one ABA therapy sessions at the conclusion of the study (after
      follow-up assessments have been collected).

      Families will receive assessment results in a brief report provided after testing is
      completed at visits 1, 5, 10 and follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Increase in child utterances
time frame: 10 weeks
description: The primary objective of this study is to determine whether T-ABA with parent training and individual child sessions is superior to T-ABA with parent training alone in improving child utterances as calculated by the LENA digital language processor.
measure: Child communication
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in increasing the number of child utterances as measured using the LENA Pro language collection device.
measure: Autism and other behavioral symptoms
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving autism and other behavioral symptoms.
measure: Language Scores
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving language scores on cognitive testing.
measure: Adaptive Behavior
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving adaptive behavior.
measure: Eye Tracking
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving eye tracking of social targets.
measure: Global Functioning
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving global functioning via VB-MAPP.
measure: Quality of Life
time frame: 10 weeks
description: To evaluate if T-ABA with combined child sessions and parent training is superior to T-ABA with parent training alone in improving quality of life.
measure: Demographics and Clinical Variables
time frame: 10 weeks
description: To evaluate whether baseline demographic and clinical variables (age, sex, IQ, parent education, parent occupation level, presence of a genetic syndrome) significantly predict patient outcomes.
measure: Parent Fidelity
time frame: 10 weeks
description: To assess if parent fidelity of T-ABA treatment predicts greater improvement in outcomes.
measure: Parent Education
time frame: 10 weeks
description: To evaluate parents' increased understanding of autism and strategies to manage their child's behavior, evaluated by a pre-/post-test regarding autism and therapeutic options.
arm group label: T-ABA Parent Training Only
arm group type: Active Comparator
description: Participants in the T-ABA Parent Training Only group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired.
arm group label: T-ABA Parent Group + Individual Therapy
arm group type: Experimental
description: Participants in the T-ABA Parent Group plus Individual Therapy group will be given Targeted Applied Behavior Analysis (T-ABA) Intervention with five weeks of parent group training and five weeks of parent-therapists one-on-one sessions. They will also be offered eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions.
intervention type: Behavioral
intervention name: Targeted Applied Behavior Analysis (T-ABA)
description: Participants will be enrolled in a five week Targeted Applied Behavior Analysis (T-ABA) parent therapy group. T-ABA parent groups will be 1.5 hours in length. Following the five weeks of parent group sessions, parents will participate in five weekly one-hour parent-therapist sessions in which a therapist will work one-on-one with the parent and their child. One treatment group (T-ABA Parent Group plus Individual Therapy) will also receive eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. The second treatment group (T-ABA Parent Training Only) will be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired.
arm group label: T-ABA Parent Group + Individual Therapy
arm group label: T-ABA Parent Training Only
criteria: 
gender: All
minimum age: 24 Months
maximum age: 71 Months
healthy volunteers: No
last name: Thomas W Frazier, PhD
role: Principal Investigator
affiliation: Cleveland Clinic Center for Autism
facility: 
country: United States
citation: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth ed. Arlington, VA: American Psychiatric Association; 2013.
citation: Kohler, F.W. Examining the services received by young children with autism and their families: A survey of parent responses. Focus on Autism and Other Developmental Disabilities. 1999;14:150-158.
citation: Stoner JB, Bock SJ, Thompson JR, Angell ME, Heyl BS, Crowley EP. Welcome to our world: Parent perceptions of interactions between parents of young children with ASD and educational professionals. Focus on Autism and Other Developmental Disabilities. 2005;20:39-51.
citation: Kogan MD, Strickland BB, Blumberg SJ, Singh GK, Perrin JM, van Dyck PC. A national profile of the health care experiences and family impact of autism spectrum disorder among children in the United States, 2005-2006. Pediatrics. 2008 Dec;122(6):e1149-58. doi: 10.1542/peds.2008-1057.
PMID: 19047216
citation: Minjarez MB, Williams SE, Mercier EM, Hardan AY. Pivotal response group treatment program for parents of children with autism. J Autism Dev Disord. 2011 Jan;41(1):92-101. doi: 10.1007/s10803-010-1027-6.
PMID: 20440638
citation: Coolican J, Smith IM, Bryson SE. Brief parent training in pivotal response treatment for preschoolers with autism. J Child Psychol Psychiatry. 2010 Dec;51(12):1321-30. doi: 10.1111/j.1469-7610.2010.02326.x.
PMID: 21073457
responsible party type: Sponsor
mesh term: Autistic Disorder