Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 5 - 8 |
| Updated: | 4/17/2018 |
| Start Date: | September 2012 |
| End Date: | May 2013 |
Effectiveness of Omega-3 Fatty Acids for the Reduction of Hyperactivity in Children With Autism Spectrum Disorder
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.
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.
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.
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
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