<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/NCT01694667</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00068694</org_study_id>
    <nct_id>NCT01694667</nct_id>
  </id_info>
  <brief_title>Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder</brief_title>
  <official_title>Effectiveness of Omega-3 Fatty Acids for the Reduction of Hyperactivity in Children With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hugo W. Moser Research Institute at Kennedy Krieger, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial&#xD;
      which will assess changes in hyperactivity in children ages five through eight with an autism&#xD;
      spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this&#xD;
      question, this study will assess changes in hyperactivity as measured by the Aberrant&#xD;
      Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity&#xD;
      who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.&#xD;
      The overwhelming majority of study procedures, including recruitment, informed consent,&#xD;
      assessment of inclusion and exclusion criteria, and collection of baseline and outcome&#xD;
      measures will take place over the internet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Families and caregivers of children enrolled in the IAN Research between the age 5-8 and with&#xD;
      an established diagnosis of autism will be invited to participate in the study by e-mail. All&#xD;
      of these families have previously given consent to be contacted about research opportunities.&#xD;
      Families who respond to the e-mail recruitment letter will undergo a brief screening process&#xD;
      to determine if the child has any exclusion criteria and to ensure the child is age 5-8, has&#xD;
      an autism spectrum disorder, and has elevated baseline levels of hyperactivity. Families will&#xD;
      undergo an on-line informed consent process including assent of the child. All participants&#xD;
      will be given an opportunity to speak with a study team member should they have any questions&#xD;
      about the study or the informed consent process. Participants will sign the informed consent&#xD;
      using an electronic signature, a process that has been used previously in the IAN network and&#xD;
      approved by the John's Hopkins Institutional Review Board (IRB). Families meeting all&#xD;
      eligibility criteria will be randomly assigned and mailed the study medication (omega-3 or&#xD;
      placebo) which will be administered to children by the parents twice daily for six weeks.&#xD;
      Both the study medication and the matching placebo are an orange-flavored pudding that is&#xD;
      specifically designed to be palatable for young children. Assessment of child hyperactivity,&#xD;
      social functioning, and overall disease severity will be measured at baseline, three and six&#xD;
      weeks by the parents, who will complete on-line standard questionnaires; ABC, Social&#xD;
      Responsiveness Scale (SRS), clinical Global Impressions Scale (CGI).&#xD;
&#xD;
      Side effects will be assessed every week by e-mail, and any report of a side effect will&#xD;
      immediately be followed-up with telephone contact from the PI. Although omega-3 fatty acids&#xD;
      are extremely safe in the prescribed doses, the PI or another study physician will still be&#xD;
      on call 24-hours-a-day, 7-days-a-week to speak to participants about possible adverse events&#xD;
      or new medical problems (all enrolled families are provided with this 24-hour emergency phone&#xD;
      contact information).&#xD;
&#xD;
      As part of the weekly e-mail reminder, parents will also be asked to log the medication that&#xD;
      was provided to their children each day of the previous week to measure medication adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score</measure>
    <time_frame>Baseline, 6 weeks (3 week value to be collected)</time_frame>
    <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Aberrant Behavior Checklist - Lethargy Subscale Score</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Aberrant Behavior Checklist - Stereotypy Subscale Score</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aberrant Behavior Checklist - Irritability Subscale Score</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aberrant Behavior Checklist - Inappropriate Speech Subscale Score</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social Responsiveness Scale (SRS) Score</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.&#xD;
A total Total-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of Autistic Disorder. T-scores of 66 through 75 are interpreted as indicating Moderate deficiencies in reciprocal social behavior that are clinically significant and lead to substantial interference in everyday social interactions, whereas T-scores of 60 to 65 are in the Mild range and indicate mild to moderate deficits in social interaction. T scores of 59 and below are considered to be within typical limits and generally not associated with clinically significant ASD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression - Improvement (CGI-I) Score</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who &quot;responded&quot; in each group is the number where the parents reported that their child was improved, much improved, or very much improved.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <condition>Hyperactivity</condition>
  <arm_group>
    <arm_group_label>Omega-3 Fatty Acids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omega-3 Fatty Acids</intervention_name>
    <description>Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).</description>
    <arm_group_label>Omega-3 Fatty Acids</arm_group_label>
    <other_name>Omega-3</other_name>
    <other_name>N-3 Fatty Acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children who are participating in Interactive Autism Network (IAN) Research Families&#xD;
&#xD;
          2. Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social&#xD;
             Communication Question (SCQ) score&gt;12&#xD;
&#xD;
          3. Age 5-8&#xD;
&#xD;
          4. Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)&gt;20&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children in foster care and each parent must affirm that they are the biological or&#xD;
             adoptive parent of the child&#xD;
&#xD;
          2. Allergy to fish&#xD;
&#xD;
          3. Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or&#xD;
             planned surgery&#xD;
&#xD;
          4. Any major medical illness that interferes with regular school attendance&#xD;
&#xD;
          5. Current or recent (past six months) use of omega-3 fatty acid&#xD;
&#xD;
          6. Siblings with ASD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A Law, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kennedy Krieger Institute and Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>This study is open to continental USA</name>
      <address>
        <city>Multiple Locations</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>March 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>April 3, 2014</results_first_submitted>
  <results_first_submitted_qc>May 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 16, 2014</results_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment was limited to children between the ages of 5 and 8 with ASD and some verbal ability. E-mail invitations were sent to the 863 registered IAN members who met the above criteria and had given prior consent to be contacted about research opportunities between September 18, 2012 and October 31, 2012.</recruitment_details>
      <pre_assignment_details>During the six-week recruitment period, 118 families expressed interest and completed the on-line screening form. Fifty-seven children from 28 states were deemed eligible and randomly assigned to study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Omega-3 Fatty Acids</title>
          <description>Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).&#xD;
Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).&#xD;
29 participants allocated to this group.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.&#xD;
Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).&#xD;
28 participants allocated to this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omega-3</title>
          <description>Participants randomized to omega-3</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants randomized to placebo</description>
        </group>
        <group group_id="B3">
          <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="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88.2" spread="12.3"/>
                    <measurement group_id="B2" value="85.0" spread="13.2"/>
                    <measurement group_id="B3" value="86.6" spread="12.7"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="50"/>
                  </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>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ABC-Hyperactivity</title>
          <description>Aberrant Behavior Checklist - measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale&#xD;
Hyperactivity - 16 items, score ranges from 0-48&#xD;
Irritability - 15 items, score ranges from 0-45&#xD;
Stereotypy - 7 questions, score ranges from 0-21&#xD;
Lethargy - 16 questions, score ranges from 0-48&#xD;
Inappropriate speech - 4 questions, score ranges from 0-12&#xD;
Subscales were not combined to compute a total score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.4" spread="8.4"/>
                    <measurement group_id="B2" value="28.1" spread="7.6"/>
                    <measurement group_id="B3" value="28.2" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ABC-Irritability</title>
          <description>Aberrant Behavior Checklist - measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale&#xD;
Hyperactivity - 16 items, score ranges from 0-48&#xD;
Irritability - 15 items, score ranges from 0-45&#xD;
Stereotypy - 7 questions, score ranges from 0-21&#xD;
Lethargy - 16 questions, score ranges from 0-48&#xD;
Inappropriate speech - 4 questions, score ranges from 0-12&#xD;
Subscales were not combined to compute a total score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.0" spread="8.9"/>
                    <measurement group_id="B2" value="16.8" spread="8.3"/>
                    <measurement group_id="B3" value="18.4" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ABC-Stereotypy</title>
          <description>Aberrant Behavior Checklist - measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale&#xD;
Hyperactivity - 16 items, score ranges from 0-48&#xD;
Irritability - 15 items, score ranges from 0-45&#xD;
Stereotypy - 7 questions, score ranges from 0-21&#xD;
Lethargy - 16 questions, score ranges from 0-48&#xD;
Inappropriate speech - 4 questions, score ranges from 0-12&#xD;
Subscales were not combined to compute a total score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.0" spread="6.0"/>
                    <measurement group_id="B2" value="5.4" spread="4.7"/>
                    <measurement group_id="B3" value="6.7" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ABC-Lethargy</title>
          <description>Aberrant Behavior Checklist - measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale&#xD;
Hyperactivity - 16 items, score ranges from 0-48&#xD;
Irritability - 15 items, score ranges from 0-45&#xD;
Stereotypy - 7 questions, score ranges from 0-21&#xD;
Lethargy - 16 questions, score ranges from 0-48&#xD;
Inappropriate speech - 4 questions, score ranges from 0-12&#xD;
Subscales were not combined to compute a total score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.2" spread="8.8"/>
                    <measurement group_id="B2" value="8.8" spread="4.2"/>
                    <measurement group_id="B3" value="10.5" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ABC-Inappropriate Speech</title>
          <description>Aberrant Behavior Checklist - measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale&#xD;
Hyperactivity - 16 items, score ranges from 0-48&#xD;
Irritability - 15 items, score ranges from 0-45&#xD;
Stereotypy - 7 questions, score ranges from 0-21&#xD;
Lethargy - 16 questions, score ranges from 0-48&#xD;
Inappropriate speech - 4 questions, score ranges from 0-12&#xD;
Subscales were not combined to compute a total score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.0" spread="3.4"/>
                    <measurement group_id="B2" value="5.8" spread="2.8"/>
                    <measurement group_id="B3" value="6.4" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score</title>
        <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48.</description>
        <time_frame>Baseline, 6 weeks (3 week value to be collected)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score</title>
          <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="7.2"/>
                    <measurement group_id="O2" value="-3.4" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Aberrant Behavior Checklist - Lethargy Subscale Score</title>
        <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Aberrant Behavior Checklist - Lethargy Subscale Score</title>
          <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="4.2"/>
                    <measurement group_id="O2" value="0.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Aberrant Behavior Checklist - Stereotypy Subscale Score</title>
        <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Aberrant Behavior Checklist - Stereotypy Subscale Score</title>
          <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="3.7"/>
                    <measurement group_id="O2" value="-0.5" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aberrant Behavior Checklist - Irritability Subscale Score</title>
        <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Aberrant Behavior Checklist - Irritability Subscale Score</title>
          <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="6.9"/>
                    <measurement group_id="O2" value="-2.1" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aberrant Behavior Checklist - Inappropriate Speech Subscale Score</title>
        <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Aberrant Behavior Checklist - Inappropriate Speech Subscale Score</title>
          <description>The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from &quot;0=no problem&quot; to &quot;3=major problem.&quot; Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.7"/>
                    <measurement group_id="O2" value="-0.9" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Social Responsiveness Scale (SRS) Score</title>
        <description>Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.&#xD;
A total Total-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of Autistic Disorder. T-scores of 66 through 75 are interpreted as indicating Moderate deficiencies in reciprocal social behavior that are clinically significant and lead to substantial interference in everyday social interactions, whereas T-scores of 60 to 65 are in the Mild range and indicate mild to moderate deficits in social interaction. T scores of 59 and below are considered to be within typical limits and generally not associated with clinically significant ASD.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Social Responsiveness Scale (SRS) Score</title>
          <description>Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.&#xD;
A total Total-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of Autistic Disorder. T-scores of 66 through 75 are interpreted as indicating Moderate deficiencies in reciprocal social behavior that are clinically significant and lead to substantial interference in everyday social interactions, whereas T-scores of 60 to 65 are in the Mild range and indicate mild to moderate deficits in social interaction. T scores of 59 and below are considered to be within typical limits and generally not associated with clinically significant ASD.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="8.3"/>
                    <measurement group_id="O2" value="-6.1" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Global Impression - Improvement (CGI-I) Score</title>
        <description>Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who &quot;responded&quot; in each group is the number where the parents reported that their child was improved, much improved, or very much improved.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega-3</title>
            <description>Participants randomized to omega-3</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Global Impression - Improvement (CGI-I) Score</title>
          <description>Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who &quot;responded&quot; in each group is the number where the parents reported that their child was improved, much improved, or very much improved.</description>
          <units># parents reporting improvement</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>Families advised at start of study to contact study coordinator if child experiences a new health problem.&#xD;
Families sent weekly e-mail which includes form asking about new health problems. If &quot;yes&quot;, study doctor contacted and reviews form and contacts participant to obtain additional info and determine if further medical evaluation/treatment required.&#xD;
AE form questions are standard questions on FDA serious adverse event (SAE) forms.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omega-3</title>
          <description>Participants randomized to omega-3</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants randomized to placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal virus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>vomitting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>sinus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Increased self-stimulatory behavior</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Increased tantrums</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma Flare</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Croup</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Elective Tonsillectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Nosebleed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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>
    <point_of_contact>
      <name_or_title>Stephen Bent</name_or_title>
      <organization>University of California, San Francisco</organization>
      <phone>415-221-4810 ext 3457</phone>
      <email>Stephen.Bent@ucsf.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/NCT01694667
org study id: NA_00068694
nct id: NCT01694667
lead sponsor: 
collaborator: 
has dmc: Yes
The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial
      which will assess changes in hyperactivity in children ages five through eight with an autism
      spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this
      question, this study will assess changes in hyperactivity as measured by the Aberrant
      Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity
      who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.
      The overwhelming majority of study procedures, including recruitment, informed consent,
      assessment of inclusion and exclusion criteria, and collection of baseline and outcome
      measures will take place over the internet.
Families and caregivers of children enrolled in the IAN Research between the age 5-8 and with
      an established diagnosis of autism will be invited to participate in the study by e-mail. All
      of these families have previously given consent to be contacted about research opportunities.
      Families who respond to the e-mail recruitment letter will undergo a brief screening process
      to determine if the child has any exclusion criteria and to ensure the child is age 5-8, has
      an autism spectrum disorder, and has elevated baseline levels of hyperactivity. Families will
      undergo an on-line informed consent process including assent of the child. All participants
      will be given an opportunity to speak with a study team member should they have any questions
      about the study or the informed consent process. Participants will sign the informed consent
      using an electronic signature, a process that has been used previously in the IAN network and
      approved by the John's Hopkins Institutional Review Board (IRB). Families meeting all
      eligibility criteria will be randomly assigned and mailed the study medication (omega-3 or
      placebo) which will be administered to children by the parents twice daily for six weeks.
      Both the study medication and the matching placebo are an orange-flavored pudding that is
      specifically designed to be palatable for young children. Assessment of child hyperactivity,
      social functioning, and overall disease severity will be measured at baseline, three and six
      weeks by the parents, who will complete on-line standard questionnaires; ABC, Social
      Responsiveness Scale (SRS), clinical Global Impressions Scale (CGI).

      Side effects will be assessed every week by e-mail, and any report of a side effect will
      immediately be followed-up with telephone contact from the PI. Although omega-3 fatty acids
      are extremely safe in the prescribed doses, the PI or another study physician will still be
      on call 24-hours-a-day, 7-days-a-week to speak to participants about possible adverse events
      or new medical problems (all enrolled families are provided with this 24-hour emergency phone
      contact information).

      As part of the weekly e-mail reminder, parents will also be asked to log the medication that
      was provided to their children each day of the previous week to measure medication adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score
time frame: Baseline, 6 weeks (3 week value to be collected)
description: The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48.
measure: Change in Aberrant Behavior Checklist - Lethargy Subscale Score
time frame: Baseline, Week 6
description: The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48.
measure: Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
time frame: Baseline, Week 6
description: The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21.
measure: Aberrant Behavior Checklist - Irritability Subscale Score
time frame: Baseline, Week 6
description: The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45.
measure: Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
time frame: Baseline, Week 6
description: The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12.
measure: Change in Social Responsiveness Scale (SRS) Score
time frame: Baseline, Week 6
description: Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.
A total Total-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of Autistic Disorder. T-scores of 66 through 75 are interpreted as indicating Moderate deficiencies in reciprocal social behavior that are clinically significant and lead to substantial interference in everyday social interactions, whereas T-scores of 60 to 65 are in the Mild range and indicate mild to moderate deficits in social interaction. T scores of 59 and below are considered to be within typical limits and generally not associated with clinically significant ASD.
measure: Change in Clinical Global Impression - Improvement (CGI-I) Score
time frame: Baseline, Week 6
description: Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who "responded" in each group is the number where the parents reported that their child was improved, much improved, or very much improved.
arm group label: Omega-3 Fatty Acids
arm group type: Active Comparator
description: Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.
intervention type: Drug
intervention name: Omega-3 Fatty Acids
description: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).
arm group label: Omega-3 Fatty Acids
other name: Omega-3
other name: N-3 Fatty Acid
intervention type: Other
intervention name: Placebo
description: Placebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.
arm group label: Placebo
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: No
last name: Paul A Law, M.D.
role: Principal Investigator
affiliation: Kennedy Krieger Institute and Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 