COMPLETED

Natural Treatments for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

Conditions

Non-verbal Learning Disorder Autism Spectrum Disorder Autism learning disorder natural supplements NAC omega-3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.

Official Title

An Open-Label Clinical Trial Conducted Via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)

Quick Facts

Study Start:2019-05-20

Study Completion:2024-05-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03757585

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* A previous established diagnosis of non-verbal learning disability (NVLD) or DSM-V Autism Spectrum Disorder and/ or combined T-scores on the Child Behavior Checklist \> 195 on the Withdrawn + Social Problems + Thought Problems subscales. * Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales. * Subjects and their caregivers must be English-speaking and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * Subjects and their caregivers must be willing and able to comply with all study procedures. * Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document. * Subject must be able to swallow pills. * Subject must have access to a computer with a camera, speaker, microphone, and internet connection.	* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. * Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. * History of bleeding diathesis, including those with von Willebrand disease. * Uncorrected hypothyroidism or hyperthyroidism. * History of sensitivity to omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician. * Severe allergies or multiple adverse drug reactions. * Unstable or untreated seizure disorder. * DSM-IV substance use, abuse or dependence. * Judged clinically to be at serious suicidal risk for C-SSRS score ≥ 4. * Current diagnosis of schizophrenia. * Current diagnosis or symptoms of psychosis. * IQ \< 70. * Pregnant or nursing. * Weighs less than 12.5kg.

Inclusion Criteria

Exclusion Criteria

* A previous established diagnosis of non-verbal learning disability (NVLD) or DSM-V Autism Spectrum Disorder and/ or combined T-scores on the Child Behavior Checklist \> 195 on the Withdrawn + Social Problems + Thought Problems subscales.
* Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist \> 180 on the Anxiety/Depression + Aggression + Attention subscales.
* Subjects and their caregivers must be English-speaking and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their caregivers must be willing and able to comply with all study procedures.
* Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
* Subject must be able to swallow pills.
* Subject must have access to a computer with a camera, speaker, microphone, and internet connection.

* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* History of bleeding diathesis, including those with von Willebrand disease.
* Uncorrected hypothyroidism or hyperthyroidism.
* History of sensitivity to omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician.
* Severe allergies or multiple adverse drug reactions.
* Unstable or untreated seizure disorder.
* DSM-IV substance use, abuse or dependence.
* Judged clinically to be at serious suicidal risk for C-SSRS score ≥ 4.
* Current diagnosis of schizophrenia.
* Current diagnosis or symptoms of psychosis.
* IQ \< 70.
* Pregnant or nursing.
* Weighs less than 12.5kg.

Contacts and Locations

Principal Investigator

Janet Wozniak, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Janet Wozniak, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-20

Study Completion Date2024-05-06

Study Record Updates

Study Start Date2019-05-20

Study Completion Date2024-05-06

Terms related to this study

Keywords Provided by Researchers

autism
learning disorder
natural supplements
NAC
omega-3

Additional Relevant MeSH Terms

Non-verbal Learning Disorder
Autism Spectrum Disorder
Autism