Natural treatments for emotional dysregulation in youth with learning disabilities and autism
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)
This study is testing whether natural treatments like omega-3s, inositol, and NAC can help kids and teens with learning disabilities or autism manage their emotions better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03757585 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and tolerability of natural treatments, specifically omega-3 fatty acids, inositol, and N-acetylcysteine (NAC), for managing mood dysregulation in children and adolescents aged 5-17 diagnosed with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). The study is a 6-week, open-label, randomized trial that aims to assess how these interventions can help improve emotional regulation in participants. By comparing the outcomes of these natural supplements, the study seeks to provide insights into alternative treatment options for youth experiencing emotional challenges associated with these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 5-17 with a diagnosis of NVLD or ASD who exhibit symptoms of emotional dysregulation.
Not a fit: Patients who do not have a diagnosis of NVLD or ASD, or those without current symptoms of emotional dysregulation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer effective natural treatment options for managing emotional dysregulation in youth with NVLD and ASD.
How similar studies have performed: Other studies exploring natural treatments for emotional dysregulation in similar populations have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Janet Wozniak, MD — Massachusetts General Hospital
- Study coordinator: Hannah O'Connor, BS
- Email: hgoconnor@mgh.harvard.edu
- Phone: 617-643-6617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.