Autism Spectrum Disorder
Conditions
Brief summary
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
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.
Interventions
DRUGfolinic acid
subject will take folinic acid daily for 12 weeks
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Between ages 5 and 25
Exclusion criteria
* Not currently taking folinic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aberrant Behavior Checklist (ABC) - Parent Reported Change | Baseline to Week 12 | 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. |
| Aberrant Behavior Checklist (ABC) - Teacher Reported Change | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Responsiveness Scale (SRS) - Parent Reported Change | Baseline to Week 12 | 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. |
| Social Responsiveness Scale (SRS) - Teacher Reported Change | Baseline to Week 12 | 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. |
| Pediatric Quality of Life (PedsQL) - Parent Reported Change | Baseline to Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Folinic Acid Open-label 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.
folinic acid: subject will take folinic acid daily for 12 weeks | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Folinic Acid Open-label |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 16 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Folinic Acid Open-label | Aberrant Behavior Checklist (ABC) - Parent Reported Change | -2.4 score on a scale |
Comparison: The parent-reported change in mean ABC total score from baseline to week 12.p-value: 0.5695% CI: [-11.3, 6.4]Paired Sample t-test
Primary
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.
Time frame: Baseline to Week 12
Population: Deleted one outlier for data analysis; deleted one subject because of missing survey time point from teacher.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Folinic Acid Open-label | Aberrant Behavior Checklist (ABC) - Teacher Reported Change | 1.2 score on a scale |
Comparison: The teacher-reported change in mean ABC total score from baseline to week 12.p-value: 0.6895% CI: [-5.2, 7.6]Paired Sample t-test
Secondary
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.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Folinic Acid Open-label | Pediatric Quality of Life (PedsQL) - Parent Reported Change | -0.8 score on a scale |
Comparison: The parent-reported change in mean PedsQL total score from baseline to week 12.p-value: 0.6995% CI: [-5.2, 3.5]Paired Sample t-test
Secondary
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.
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Folinic Acid Open-label | Social Responsiveness Scale (SRS) - Parent Reported Change | -7.8 score on a scale |
Comparison: The parent-reported change in mean SRS total score from baseline to week 12.p-value: 0.09595% CI: [-17.3, 1.6]Paired Sample t-test
Secondary
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.
Time frame: Baseline to Week 12
Population: Deleted one outlier for data analysis; deleted one subject because of missing survey time point from teacher.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Folinic Acid Open-label | Social Responsiveness Scale (SRS) - Teacher Reported Change | -0.5 score on a scale |
Comparison: The teacher-reported change in mean SRS total score from baseline to week 12.p-value: 0.9595% CI: [-7, 13.5]Wilcoxon (Mann-Whitney)