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

University of Medicine and Dentistry of New Jersey17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Autism

Outcomes

Primary Outcomes

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

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

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)

Secondary Outcomes

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)

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.