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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 Fatty Acids | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acids | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks (3 week value to be collected) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Law, M.D. | Kennedy Krieger Institute and Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| This study is open to continental USA | Multiple Locations | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24839884 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Fatty Acids | 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). 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). 29 participants allocated to this group. |
| FG001 | 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. 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). 28 participants allocated to this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 | Participants randomized to omega-3 |
| BG001 | Placebo | Participants randomized to placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 weeks (3 week value to be collected) |
|
6 weeks
AE form questions are standard questions on FDA serious adverse event (SAE) forms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 | Participants randomized to omega-3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Flare | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Bent | University of California, San Francisco | 415-221-4810 | 3457 | Stephen.Bent@ucsf.edu |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
|
| Placebo | Other | 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. |
|
| 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. | 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. | 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. | 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. | 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. | Baseline, Week 6 |
| BG002 |
| Total |
Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ABC-Hyperactivity | 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 Hyperactivity - 16 items, score ranges from 0-48 Irritability - 15 items, score ranges from 0-45 Stereotypy - 7 questions, score ranges from 0-21 Lethargy - 16 questions, score ranges from 0-48 Inappropriate speech - 4 questions, score ranges from 0-12 Subscales were not combined to compute a total score. | Mean | Standard Deviation | units on a scale |
|
| ABC-Irritability | 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 Hyperactivity - 16 items, score ranges from 0-48 Irritability - 15 items, score ranges from 0-45 Stereotypy - 7 questions, score ranges from 0-21 Lethargy - 16 questions, score ranges from 0-48 Inappropriate speech - 4 questions, score ranges from 0-12 Subscales were not combined to compute a total score. | Mean | Standard Deviation | units on a scale |
|
| ABC-Stereotypy | 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 Hyperactivity - 16 items, score ranges from 0-48 Irritability - 15 items, score ranges from 0-45 Stereotypy - 7 questions, score ranges from 0-21 Lethargy - 16 questions, score ranges from 0-48 Inappropriate speech - 4 questions, score ranges from 0-12 Subscales were not combined to compute a total score. | Mean | Standard Deviation | units on a scale |
|
| ABC-Lethargy | 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 Hyperactivity - 16 items, score ranges from 0-48 Irritability - 15 items, score ranges from 0-45 Stereotypy - 7 questions, score ranges from 0-21 Lethargy - 16 questions, score ranges from 0-48 Inappropriate speech - 4 questions, score ranges from 0-12 Subscales were not combined to compute a total score. | Mean | Standard Deviation | units on a scale |
|
| ABC-Inappropriate Speech | 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 Hyperactivity - 16 items, score ranges from 0-48 Irritability - 15 items, score ranges from 0-45 Stereotypy - 7 questions, score ranges from 0-21 Lethargy - 16 questions, score ranges from 0-48 Inappropriate speech - 4 questions, score ranges from 0-12 Subscales were not combined to compute a total score. | Mean | Standard Deviation | units on a scale |
|
Participants randomized to placebo
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 6 |
|
|
|
| Secondary | 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. | Posted | Number | # parents reporting improvement | Baseline, Week 6 |
|
|
|
| 0 |
| 29 |
| 10 |
| 29 |
| EG001 | Placebo | Participants randomized to placebo | 0 | 28 | 6 | 28 |
| Croup | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elective Tonsillectomy | Surgical and medical procedures | Systematic Assessment |
|
| Gastrointestinal virus | Gastrointestinal disorders | Systematic Assessment |
|
| Increased self-stimulatory behavior | Psychiatric disorders | Systematic Assessment |
|
| Increased tantrums | Psychiatric disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nosebleed | Vascular disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sinus infection | Infections and infestations | Systematic Assessment |
|
| Viral upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| vomitting | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |