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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Omega 3 fatty acids

Placebo

About this trial

This is an interventional treatment trial for Autism focused on measuring Aggression, Irritability, Global severity

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Behavioral Health Care Building, UMDNJ-RWJMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega 3 fatty Acids, drug

Placebo

Arm Description

Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.

The placebo will be dispensed to subjects in the control group

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00467818

First Posted

April 27, 2007

Last Updated

January 7, 2021

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT00467818

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism

Keywords

Aggression, Irritability, Global severity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega 3 fatty Acids, drug

Arm Type

Active Comparator

Arm Description

Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The placebo will be dispensed to subjects in the control group

Intervention Type

Drug

Intervention Name(s)

Omega 3 fatty acids

Other Intervention Name(s)

DHA and EPA

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Same dosage as that of omega 3 fatty acids

Primary Outcome Measure Information:

Title

Clinical Global Impression Scale(CGI)- Improvement

Description

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

Title

Aberrant Behavior Checklist (ABC)

Description

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

Title

Vineland Adaptive Behavior Scale

Description

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 Outcome Measure Information:

Title

Overt Aggression Scale-Modified

Description

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)

Title

Parental Stress Index

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherie L. Novotny, MD

Organizational Affiliation

Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Behavioral Health Care Building, UMDNJ-RWJMS

City

Piscataway

State/Province

New Jersey

ZIP/Postal Code

08854

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

There is no plan at this time.

Citations:

Citation

Amminger GP, Berger GE, Schafer MR, Klier C, Friedrich MH, Feucht M. Omega-3 Fatty Acids Supplementation in Children with Autism. Biol Psychiatry. 2006 Aug 22 Harel Z, Gascon G, Riggs S, Vaz R, Brown W, Exil G. Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. J Adolesc Health. 2002 Aug;31(2):154-61. Itomura M, Hamazaki K, Sawazaki S, Kobayashi M, Terasawa K, Watanabe S, Hamazaki T. The effect of fish oil on physical aggression in schoolchildren. J Nutr Biochem. 2005 Mar;16(3):163-71. Mitchell EA, Aman MG, Turbott SH, Manku M. Clinical characteristics and serum essential fatty acid levels in hyperactive children. Clin Pediatr 1987; 26:406-11. Nemets H, Nemets B, Apter A, Bracha Z, Belmaker RH Omega-3 treatment of childhood depression: Am J Psychiatry. 2006 Jun;163(6):1098-100. Richardson AJ, Montgomery P. The Oxford-Durham study. Pediatrics. 2005 May;115(5):1360-6.

Results Reference

result

Links:

URL

http://ubhc.umdnj.edu/

Description

University Behavior Health Care official website

Autism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial