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

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.

Conditions

Non-verbal Learning Disorder, Autism Spectrum Disorder, Autism

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Non-verbal Learning Disorder
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 195 on the Withdrawn + Social Problems + Thought Problems subscales.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.

Ages Eligible for Study

5 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Janet Wozniak, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2024-07