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Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT01694667
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : June 16, 2014
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Tracking Information
First Submitted Date  ICMJE March 26, 2012
First Posted Date  ICMJE September 27, 2012
Results First Submitted Date  ICMJE April 3, 2014
Results First Posted Date  ICMJE June 16, 2014
Last Update Posted Date March 15, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score [ Time Frame: Baseline, 6 weeks (3 week value to be collected) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score [ Time Frame: Baseline, Week 3, Week 6 ]
The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "no problem" to "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.
Change History Complete list of historical versions of study NCT01694667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
  • Change in Aberrant Behavior Checklist - Lethargy Subscale Score [ Time Frame: Baseline, Week 6 ]
    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.
  • Change in Aberrant Behavior Checklist - Stereotypy Subscale Score [ Time Frame: Baseline, Week 6 ]
    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.
  • Aberrant Behavior Checklist - Irritability Subscale Score [ Time Frame: Baseline, Week 6 ]
    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.
  • Aberrant Behavior Checklist - Inappropriate Speech Subscale Score [ Time Frame: Baseline, Week 6 ]
    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.
  • Change in Social Responsiveness Scale (SRS) Score [ Time Frame: Baseline, Week 6 ]
    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.
  • Change in Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Baseline, Week 6 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • Change in Aberrant Behavior Checklist - Lethargy Subscale Score [ Time Frame: Baseline, Week 3, Week 6 ]
    The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "no problem" to "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.
  • Change in Aberrant Behavior Checklist - Stereotypy Subscale Score [ Time Frame: Baseline, Week 3, Week 6 ]
    The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "no problem" to "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.
  • Aberrant Behavior Checklist - Irritability Subscale Score [ Time Frame: Baseline, Week 3, Week 6 ]
    The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "no problem" to "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.
  • Aberrant Behavior Checklist - Inappropriate Speech Subscale Score [ Time Frame: Baseline, Week 3, Week 6 ]
    The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "no problem" to "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.
  • Change in Social Responsiveness Scale (SRS) Score [ Time Frame: Baseline, Week 3, Week 6 ]
    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.
  • Change in Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Baseline, Week 3, Week 6 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
Official Title  ICMJE Effectiveness of Omega-3 Fatty Acids for the Reduction of Hyperactivity in Children With Autism Spectrum Disorder
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorders
  • Hyperactivity
Intervention  ICMJE
  • Drug: 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).
    Other Names:
    • Omega-3
    • N-3 Fatty Acid
  • Other: Placebo
    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.
Study Arms  ICMJE
  • Active Comparator: Omega-3 Fatty Acids
    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
    Intervention: Drug: Omega-3 Fatty Acids
  • Placebo Comparator: Placebo
    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: Other: Placebo
Publications * Bent S, Hendren RL, Zandi T, Law K, Choi JE, Widjaja F, Kalb L, Nestle J, Law P. Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):658-66. doi: 10.1016/j.jaac.2014.01.018. Epub 2014 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2013)
57
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
100
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children who are participating in Interactive Autism Network (IAN) Research Families
  2. Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social Communication Question (SCQ) score>12
  3. Age 5-8
  4. Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)>20

Exclusion Criteria:

  1. Children in foster care and each parent must affirm that they are the biological or adoptive parent of the child
  2. Allergy to fish
  3. Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or planned surgery
  4. Any major medical illness that interferes with regular school attendance
  5. Current or recent (past six months) use of omega-3 fatty acid
  6. Siblings with ASD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694667
Other Study ID Numbers  ICMJE NA_00068694
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study Sponsor  ICMJE Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Paul A Law, M.D. Kennedy Krieger Institute and Johns Hopkins University
PRS Account Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP