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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism

Intervention / Treatment
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* Drug: Omega 3 fatty acids
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega 3 fatty Acids, drug<br>Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. | Drug: Omega 3 fatty acids<br>* The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.<br>* Other names: DHA and EPA;|
| Placebo Comparator: Placebo<br>The placebo will be dispensed to subjects in the control group | Other: Placebo<br>* Same dosage as that of omega 3 fatty acids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Administered biweekly, endpoint score (week 12) only used for data analysis | 
| 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. | Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported | 
| 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. | Administered during the baseline visit and on week 12 ( termination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Administered biweekly and at week 12 (termination) | 
| 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. | Administered during the baseline visit and on week 12 ( termination) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aggression, Irritability, Global severity