<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/NCT02222662</url>
  </required_header>
  <id_info>
    <org_study_id>R40MC24945(2)</org_study_id>
    <nct_id>NCT02222662</nct_id>
  </id_info>
  <brief_title>Parent-delivered Massage for Children With Autism - Ages 6 to 11</brief_title>
  <official_title>Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Oregon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HRSA/Maternal and Child Health Bureau</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Western Oregon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute&#xD;
      at Western Oregon University (WOU) will be conducting research on the effect of a&#xD;
      parent-delivered massage program on measures of autism and general development in children&#xD;
      ages 6 to 11 with autism. Families will participate in an initial training, and receive 24&#xD;
      sessions of ongoing support and training from a trained therapist over the first nine months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children will be randomly divided into treatment groups and wait-list control groups. The&#xD;
      control groups begin treatment five months after the treatment groups begin.&#xD;
&#xD;
      All children will be tested on three occasions in the first year: prior to beginning&#xD;
      treatment, and five and twelve months later. Results will be shared with parents at the end&#xD;
      of each year. Testers will remain blinded as to which group is currently receiving treatment.&#xD;
&#xD;
      There is no cost to parents for participation in this research study. Families meeting the&#xD;
      eligibility criteria will be accepted into the study on a first-come, first-served basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in severity of autism</measure>
    <time_frame>5 months and one year</time_frame>
    <description>The Childhood Autism Rating Scales will be used to measure this.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in developmental skills</measure>
    <time_frame>5 months and one year</time_frame>
    <description>The Vineland II will be used to measure this.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in communication skills</measure>
    <time_frame>5 months and one year</time_frame>
    <description>The Preschool Language Scale-5 will be used to measure this.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in co-morbid symptoms of autism</measure>
    <time_frame>5 months and one year</time_frame>
    <description>The Sense and Self-Regulation Checklist will be used to measure this.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in degree of parenting stress</measure>
    <time_frame>5 months and one year</time_frame>
    <description>The Autism Parenting Stress Index will be used to measure this.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Parent massage tx group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this group receive the parent-delivered massage intervention right after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent massage wait-list control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this group receive the parent-delivered massage intervention 5 months after randomization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parent massage tx group</intervention_name>
    <description>The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.</description>
    <arm_group_label>Parent massage tx group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parent massage wait-list control group</intervention_name>
    <description>The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.</description>
    <arm_group_label>Parent massage wait-list control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a medical and/or educational diagnosis of autism&#xD;
&#xD;
          -  Be between the age of 6 and 11&#xD;
&#xD;
          -  Parents willing to attend the parent training session and transport the child to&#xD;
             treatment sessions with trained staff 20 times in the first five months&#xD;
&#xD;
          -  Parents willing to give the fifteen-minute massage daily&#xD;
&#xD;
          -  Parents willing not to start any new interventions unless medically necessary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking psychoactive medication or pharmaceutical chelation therapy&#xD;
&#xD;
          -  Additional chronic disability (for example, cerebral palsy or uncontrolled seizures)&#xD;
&#xD;
          -  Receiving more than fifteen hours per week of intensive behavioral treatment for&#xD;
             autism (e.g. Applied Behavior Analysis therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louisa Silva, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Oregon University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Various locations in Portland, Salem, Albany/Corvallis and Eugene</name>
      <address>
        <city>Portland, Salem, Albany, Corvallis, Eugene</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://qsti.org</url>
    <description>Qigong Sensory Treatment Massage for Autism</description>
  </link>
  <reference>
    <citation>Silva LM, Schalock M, Ayres R, Bunse C, Budden S. Qigong massage treatment for sensory and self-regulation problems in young children with autism: a randomized controlled trial. Am J Occup Ther. 2009 Jul-Aug;63(4):423-32. doi: 10.5014/ajot.63.4.423.</citation>
    <PMID>19708471</PMID>
  </reference>
  <reference>
    <citation>Silva L, Schalock M. Treatment of tactile impairment in young children with autism: results with qigong massage. Int J Ther Massage Bodywork. 2013 Dec 3;6(4):12-20. doi: 10.3822/ijtmb.v6i4.227. eCollection 2013.</citation>
    <PMID>24298297</PMID>
  </reference>
  <reference>
    <citation>Silva LM, Schalock M, Gabrielsen K. Early intervention for autism with a parent-delivered Qigong massage program: a randomized controlled trial. Am J Occup Ther. 2011 Sep-Oct;65(5):550-9. doi: 10.5014/ajot.2011.000661.</citation>
    <PMID>22026323</PMID>
  </reference>
  <reference>
    <citation>Silva LM, Schalock M, Ayres R. A model and treatment for autism at the convergence of Chinese medicine and Western science: first 130 cases. Chin J Integr Med. 2011 Jun;17(6):421-9. doi: 10.1007/s11655-011-0635-0. Epub 2011 Jun 10.</citation>
    <PMID>21660676</PMID>
  </reference>
  <reference>
    <citation>Silva LM, Schalock M, Gabrielsen KR, Budden SS, Buenrostro M, Horton G. Early Intervention with a Parent-Delivered Massage Protocol Directed at Tactile Abnormalities Decreases Severity of Autism and Improves Child-to-Parent Interactions: A Replication Study. Autism Res Treat. 2015;2015:904585. doi: 10.1155/2015/904585. Epub 2015 Mar 24.</citation>
    <PMID>25878901</PMID>
  </reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Oregon University</investigator_affiliation>
    <investigator_full_name>Louisa Silva</investigator_full_name>
    <investigator_title>Principal Investigator, Visiting Professor</investigator_title>
  </responsible_party>
  <keyword>Massage</keyword>
  <keyword>effectiveness</keyword>
  <keyword>autism</keyword>
  <keyword>parent stress</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/NCT02222662
org study id: R40MC24945(2)
nct id: NCT02222662
lead sponsor: 
collaborator: 
has dmc: No
Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute
      at Western Oregon University (WOU) will be conducting research on the effect of a
      parent-delivered massage program on measures of autism and general development in children
      ages 6 to 11 with autism. Families will participate in an initial training, and receive 24
      sessions of ongoing support and training from a trained therapist over the first nine months.
Children will be randomly divided into treatment groups and wait-list control groups. The
      control groups begin treatment five months after the treatment groups begin.

      All children will be tested on three occasions in the first year: prior to beginning
      treatment, and five and twelve months later. Results will be shared with parents at the end
      of each year. Testers will remain blinded as to which group is currently receiving treatment.

      There is no cost to parents for participation in this research study. Families meeting the
      eligibility criteria will be accepted into the study on a first-come, first-served basis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in severity of autism
time frame: 5 months and one year
description: The Childhood Autism Rating Scales will be used to measure this.
measure: Change in developmental skills
time frame: 5 months and one year
description: The Vineland II will be used to measure this.
measure: Change in communication skills
time frame: 5 months and one year
description: The Preschool Language Scale-5 will be used to measure this.
measure: Change in co-morbid symptoms of autism
time frame: 5 months and one year
description: The Sense and Self-Regulation Checklist will be used to measure this.
measure: Change in degree of parenting stress
time frame: 5 months and one year
description: The Autism Parenting Stress Index will be used to measure this.
arm group label: Parent massage tx group
arm group type: Experimental
description: Children in this group receive the parent-delivered massage intervention right after randomization.
arm group label: Parent massage wait-list control group
arm group type: Experimental
description: Children in this group receive the parent-delivered massage intervention 5 months after randomization.
intervention type: Other
intervention name: Parent massage tx group
description: The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
arm group label: Parent massage tx group
intervention type: Other
intervention name: Parent massage wait-list control group
description: The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
arm group label: Parent massage wait-list control group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Louisa Silva, MD MPH
role: Principal Investigator
affiliation: Western Oregon University
facility: 
country: United States
url: http://qsti.org
description: Qigong Sensory Treatment Massage for Autism
citation: Silva LM, Schalock M, Ayres R, Bunse C, Budden S. Qigong massage treatment for sensory and self-regulation problems in young children with autism: a randomized controlled trial. Am J Occup Ther. 2009 Jul-Aug;63(4):423-32. doi: 10.5014/ajot.63.4.423.
PMID: 19708471
citation: Silva L, Schalock M. Treatment of tactile impairment in young children with autism: results with qigong massage. Int J Ther Massage Bodywork. 2013 Dec 3;6(4):12-20. doi: 10.3822/ijtmb.v6i4.227. eCollection 2013.
PMID: 24298297
citation: Silva LM, Schalock M, Gabrielsen K. Early intervention for autism with a parent-delivered Qigong massage program: a randomized controlled trial. Am J Occup Ther. 2011 Sep-Oct;65(5):550-9. doi: 10.5014/ajot.2011.000661.
PMID: 22026323
citation: Silva LM, Schalock M, Ayres R. A model and treatment for autism at the convergence of Chinese medicine and Western science: first 130 cases. Chin J Integr Med. 2011 Jun;17(6):421-9. doi: 10.1007/s11655-011-0635-0. Epub 2011 Jun 10.
PMID: 21660676
citation: Silva LM, Schalock M, Gabrielsen KR, Budden SS, Buenrostro M, Horton G. Early Intervention with a Parent-Delivered Massage Protocol Directed at Tactile Abnormalities Decreases Severity of Autism and Improves Child-to-Parent Interactions: A Replication Study. Autism Res Treat. 2015;2015:904585. doi: 10.1155/2015/904585. Epub 2015 Mar 24.
PMID: 25878901
responsible party type: Principal Investigator
investigator affiliation: Western Oregon University
investigator full name: Louisa Silva
investigator title: Principal Investigator, Visiting Professor
mesh term: Autistic Disorder