Folinic Acid in Autism

Study Overview
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Brief Summary
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An examination of changes in urinary metabolites with use of folinic acid in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures and academic measures monthly at school with teachers and parents report.

Detailed Description
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Children enrolled in Oak Hill School will enroll in this study and take folinic acid supplement twice a day for 12 weeks period. Behavioral measures and urinary metabolites will be collected pre and post treatment. Behavioral measures will be taken again at 16 weeks, after 4 weeks of not dosing.

Official Title
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An Examination of Changes in Urinary Metabolites With Use of Folinic Acid in Children With Autism Spectrum Disorder (ASD)

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: folinic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages 5 and 25 Exclusion Criteria: Not currently taking folinic acid

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label<br>In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose. | Drug: folinic acid<br>* subject will take folinic acid daily for 12 weeks<br>* Other names: leucovorin calcium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist (ABC) - Parent Reported Change | The Aberrant Behavior Checklist - parent reported version measures aberrant behavior in children and young adults. There are 58 questions.The scoring of one question can range from 0 (not a problem) to 3 (severe) points on a Likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time. Scoring from 0-3 Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3 Lower score indicates better performance. | Baseline to Week 12 | 
| Aberrant Behavior Checklist (ABC) - Teacher Reported Change | The Aberrant Behavior Checklist - teacher reported version measures aberrant behavior in children and young adults. There are 58 questions. The scoring of ABC questions can range from 0 (not a problem) to 3 (severe) points on a likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time. Scoring from 0-3 Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3 Lower score indicates better performance. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale (SRS) - Parent Reported Change | The Social Responsiveness Scale - parent reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Analysis will be performed for mean of total score change over time. Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4 Lower score indicates better performance. | Baseline to Week 12 | 
| Social Responsiveness Scale (SRS) - Teacher Reported Change | The Social Responsiveness Scale - teacher reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Analysis will be performed for mean of total score change over time. Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4 Lower score indicates better performance. | Baseline to Week 12 | 
| Pediatric Quality of Life (PedsQL) - Parent Reported Change | Pediatric Quality of Life is reported by parent only and it assesses improvement of the child's overall quality of life through questions about physical, emotional, social and school functioning. There are 23 questions. The scoring of PedsQL questions can range from 0 (Never) to 4 (Almost Always) points on a Likert scale. Questions are reversed scored and linearly transformed to a 0 - 100 scale for data analysis as follows: 0=100, 1=75, 2=50, 3=23, 4=0. The total score = sum of all the questions over the number of items answered on. The total possible score range for the PedsQL is 0 - 100. Analysis will be performed for mean of total score change over time. Scoring from 0 to 4 Never = 0, Almost Never = 1, Sometimes = 2, Often = 3, Almost Always =4 Higher score indicates better performance. | Baseline to Week 12 |