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Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00467818
Enrollment
17
Registered
2007-05-01
Start date
2007-01-31
Completion date
2010-12-31
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

Aggression, Irritability, Global severity

Brief summary

Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses: * Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism. * Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism. * Omega 3 fatty acids will be superior to placebo in improving functional ability.

Detailed description

This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial.

Interventions

The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.

OTHERPlacebo

Same dosage as that of omega 3 fatty acids

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Medicine and Dentistry of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Child/Teen has autism. * He/She is between five and seventeen years of age. * He/She is not in the hospital. * He/She has a parent or legal guardian who is willing and able to sign the informed consent.

Exclusion criteria

* Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression). * He/She has caused visible harm to him/herself or is at risk for suicide. * He/She has an active seizure disorder or epilepsy (seizures within the past year). * He/She has an unstable medical illness, including heart disease. * He/She has experienced brain injury. * He/She has a history of diabetes. * He/She has a history of prior treatment with Omega 3 Fatty Acids. * He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility. * A pregnant female or unwilling to use acceptable contraception if sexually active.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Global Impression Scale(CGI)- ImprovementAdministered biweekly, endpoint score (week 12) only used for data analysisThis scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.
Aberrant Behavior Checklist (ABC)Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reportedAberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart & Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.
Vineland Adaptive Behavior ScaleAdministered during the baseline visit and on week 12 ( termination)The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.

Secondary

MeasureTime frameDescription
Overt Aggression Scale-ModifiedAdministered biweekly and at week 12 (termination)The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome.
Parental Stress IndexAdministered during the baseline visit and on week 12 ( termination)This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505.

Countries

United States

Participant flow

Recruitment details

Recruitment was difficult for this study due to multiple disruptions in the flow of the study due to issues with the IRB process. Additionally, there were periods of time when there was not a research coordinator to assist with recruitment and pt flow.

Pre-assignment details

Participants were required to undergo diagnostic testing and intelligence testing prior to starting the study. Individuals who were unable to participate in these processes were not allowed to enter into the active phase of the study.

Participants by arm

ArmCount
Omega 3 Fatty Acids, Drug
Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.
9
Placebo
The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids
8
Total17

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudyLost to Follow-up22

Baseline characteristics

CharacteristicPlaceboOmega 3 Fatty Acids, DrugTotal
Age, Categorical
<=18 years
8 Participants9 Participants17 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous10.6 years
STANDARD_DEVIATION 3.5
11.7 years
STANDARD_DEVIATION 3.5
11.2 years
STANDARD_DEVIATION 3.5
Region of Enrollment
United States
8 participants9 participants17 participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
7 Participants8 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 90 / 8
serious
Total, serious adverse events
0 / 91 / 8

Outcome results

Primary

Aberrant Behavior Checklist (ABC)

Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart & Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.

Time frame: Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported

Population: Youth and adolescents ages 5-17 with autism spectrum disorder

ArmMeasureValue (MEAN)Dispersion
Omega 3 Fatty Acids, DrugAberrant Behavior Checklist (ABC)5.66 units on a scaleStandard Deviation 5
PlaceboAberrant Behavior Checklist (ABC)8.5 units on a scaleStandard Deviation 2.1
p-value: 0.1Mixed Models Analysis
Primary

Clinical Global Impression Scale(CGI)- Improvement

This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.

Time frame: Administered biweekly, endpoint score (week 12) only used for data analysis

ArmMeasureValue (MEAN)Dispersion
Omega 3 Fatty Acids, DrugClinical Global Impression Scale(CGI)- Improvement3.57 units on a scaleStandard Deviation 1.2
PlaceboClinical Global Impression Scale(CGI)- Improvement3.8 units on a scaleStandard Deviation 1.2
p-value: 1t-test, 2 sided
Primary

Vineland Adaptive Behavior Scale

The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.

Time frame: Administered during the baseline visit and on week 12 ( termination)

ArmMeasureValue (MEAN)Dispersion
Omega 3 Fatty Acids, DrugVineland Adaptive Behavior Scale51.5 units on a scaleStandard Deviation 13.28
PlaceboVineland Adaptive Behavior Scale27.5 units on a scaleStandard Deviation 9.81
Secondary

Overt Aggression Scale-Modified

The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome.

Time frame: Administered biweekly and at week 12 (termination)

ArmMeasureValue (MEAN)Dispersion
Omega 3 Fatty Acids, DrugOvert Aggression Scale-Modified3.8 units on a scaleStandard Deviation 2.7
PlaceboOvert Aggression Scale-Modified2.4 units on a scaleStandard Deviation 2.6
p-value: <0.5Mixed Models Analysis
Secondary

Parental Stress Index

This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505.

Time frame: Administered during the baseline visit and on week 12 ( termination)

ArmMeasureValue (MEAN)Dispersion
Omega 3 Fatty Acids, DrugParental Stress Index314.2 units on a scaleStandard Deviation 35.2
PlaceboParental Stress Index279.5 units on a scaleStandard Deviation 35.4
p-value: 0.5Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026