A Phase 2 interventional study of Omega-3 Fatty Acids and Placebo in Autism Spectrum Disorders and Hyperactivity, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Completed at 1 site in United States. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2020-08-31.
Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Phase 2, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 57 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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
Drug: Omega-3 Fatty Acids
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.
Other: Placebo
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).
Also known as: Omega-3, N-3 Fatty Acid
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.
Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score
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.
Time frame: Baseline, 6 weeks (3 week value to be collected)
Change in Aberrant Behavior Checklist - Lethargy Subscale Score
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.
Time frame: Baseline, Week 6
Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
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.
Time frame: Baseline, Week 6
Aberrant Behavior Checklist - Irritability Subscale Score
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.
Time frame: Baseline, Week 6
Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
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.
Time frame: Baseline, Week 6
Change in Social Responsiveness Scale (SRS) Score
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.
Time frame: Baseline, Week 6
Change in Clinical Global Impression - Improvement (CGI-I) Score
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.
Time frame: Baseline, Week 6
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.
| Milestone | Omega-3 Fatty Acids | Placebo |
|---|---|---|
| Started | 29 | 28 |
| Completed | 29 | 28 |
| Not completed | 0 | 0 |
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.
| units on a scale | Omega-3 | Placebo |
|---|---|---|
| Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score | -5.3 ± 7.2 | -3.4 ± 7.5 |
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.
| units on a scale | Omega-3 | Placebo |
|---|---|---|
| Change in Aberrant Behavior Checklist - Lethargy Subscale Score | -2.1 ± 4.2 | 0.1 ± 2.6 |
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.
| units on a scale | Omega-3 | Placebo |
|---|---|---|
| Change in Aberrant Behavior Checklist - Stereotypy Subscale Score | -2.0 ± 3.7 | -0.5 ± 2.6 |
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.
| units on a scale | Omega-3 | Placebo |
|---|---|---|
| Aberrant Behavior Checklist - Irritability Subscale Score | -2.0 ± 6.9 | -2.1 ± 4.4 |
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.
| units on a scale | Omega-3 | Placebo |
|---|---|---|
| Aberrant Behavior Checklist - Inappropriate Speech Subscale Score | -0.6 ± 2.7 | -0.9 ± 2.2 |
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.
| Units on a scale | Omega-3 | Placebo |
|---|---|---|
| Change in Social Responsiveness Scale (SRS) Score | -2.6 ± 8.3 | -6.1 ± 7.8 |
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.
| # parents reporting improvement | Omega-3 | Placebo |
|---|---|---|
| Change in Clinical Global Impression - Improvement (CGI-I) Score | 12 | 10 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omega-3 | — | 0/29 (0%) | 10/29 (34.5%) |
| Placebo | — | 0/28 (0%) | 6/28 (21.4%) |
| Event | Omega-3 | Placebo |
|---|---|---|
| Increased tantrumsPsychiatric disorders | 2/29 | 0/28 |
| vomittingGastrointestinal disorders | 2/29 | 0/28 |
| Asthma FlareRespiratory, thoracic and mediastinal disorders | 0/29 | 1/28 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/29 | 1/28 |
| ConjunctivitisEye disorders | 0/29 | 1/28 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/29 | 1/28 |
| sinus infectionInfections and infestations | 0/29 | 1/28 |
| Viral upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 0/29 | 1/28 |
| CroupRespiratory, thoracic and mediastinal disorders | 1/29 | 0/28 |
| Elective TonsillectomySurgical and medical procedures | 1/29 | 0/28 |
| Age, Continuous(months) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Mean | 88.2 ± 12.3 | 85.0 ± 13.2 | 86.6 ± 12.7 |
| Sex: Female, Male(Participants) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 26 | 24 | 50 |
| Race (NIH/OMB)(Participants) | Omega-3 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 24 | 23 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| ABC-Hyperactivity(units on a scale) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Mean | 28.4 ± 8.4 | 28.1 ± 7.6 | 28.2 ± 8.0 |
| ABC-Irritability(units on a scale) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Mean | 20.0 ± 8.9 | 16.8 ± 8.3 | 18.4 ± 8.7 |
| ABC-Stereotypy(units on a scale) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Mean | 8.0 ± 6.0 | 5.4 ± 4.7 | 6.7 ± 5.5 |
| ABC-Lethargy(units on a scale) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Mean | 12.2 ± 8.8 | 8.8 ± 4.2 | 10.5 ± 7.1 |
| ABC-Inappropriate Speech(units on a scale) | Omega-3 | Placebo | Total |
|---|---|---|---|
| Mean | 7.0 ± 3.4 | 5.8 ± 2.8 | 6.4 ± 3.2 |
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.