Trial · NCT02839915
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder
NCT02839915, Phase 2, Active not recruiting, Southwest Autism Research & Resource Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder. Trials, record NCT02839915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02839915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder
- NCT number
- NCT02839915
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Southwest Autism Research & Resource Center
- Conditions
- Autism Spectrum Disorder
- Interventions
- Folinic Acid, Placebo
- First posted
- 2016-07-21
- Last updated
- 2026-04-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Clinical Evaluation of Language Fundamentals 4 (CELF-4) Score. | Screening, Week 12 | The Scale title is the "Clinical Evaluation of Language Fundamentals 4" which is abbreviated as CELF-4 as indicated in the title above. Higher Scores indicate better performance. The Minimum Scaled Score is 40 and the Maximum Scaled Score is 160. The CELF-4 will be administered for participants between \> 6.6 and \< 12.5 years of age. The CELF-4 is comprised of 4 subtests intended to identify language problems and can be used to track progress over time. Administration of the CELF takes 30-45 minutes. The Core-CELF score is a composite that includes receptive and expressive language. Using the tables in the manual, raw scores from the four subtests are compared to normative data by age. The population mean = 100 + 15. |
| Primary | Change in Clinical Evaluation of Language Fundamentals Preschool (CELF-P) score | Screening, Week 12 | The Scale title is the "Clinical Evaluation of Language Fundamentals Preschool" which is abbreviated as CELF-P as indicated in the title above. Higher Scores indicate better performance. The Minimum Scaled Score is 40 and the Maximum Scaled Score is 160. The CELF-P will be administered for participants between \> 5.0 and \< 6.5 years of age to obtain an estimate of expressive and receptive language skills (based on population mean of 100 +15). Administration of the Core CELF-P takes 20-30 minutes. To make the CELF-P match the CELF-4, one additional subtest on CELF-P called the Concepts and Following Directions was added (this subtest is included in the Core of the CELF-4, but not included in the Core CELF-P). |
| Secondary | Change in Clinician Global Impression for Improvement (CGI-I) Score | Up to 12 Weeks | The CGI-I is a 7-point measure of overall symptomatic change compared to baseline that will be used as a key secondary outcome measure. Scores range from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse). The CGI-I will be rated by a clinician who is blind to treatment assignment, and will not engage in discussion of adverse events and medication dose. Ratings of "Much Improved" or "Very Much Improved" on the CGI-I will be used to define positive response. Subjects who drop out will be rated as non-responders. |
| Other | Change in the age appropriate version of the CELF compared to the pre-treatment level in the open-label extension phase | Pre-treatment, and 24weeks (or early termination) | Change in the age appropriate version of the CELF compared to the pre-treatment level will be evaluated |
| Other | Change in folate gene expression | Pre-treatment, 12 weeks(optional), and 24weeks (or early termination) | Change in folate gene expression will be assessed by blood RNA test |
| Other | Change in in methylation | Pre-treatment, 12 weeks (optional), and 24weeks (or early termination) | Change in in methylation will be assessed by blood DNA test (or saliva test if the blood sample was insufficient) |
| Other | Change in Aberrant Behavior Checklist (ABC) Score | Up to 12 Weeks | The ABC is a 58-item consisting five subscales: hyperactivity, irritability, social withdrawal, stereotypic behavior and inappropriate speech in children with developmental disabilities. A higher score indicates more frequent aberrant behaviors. |
| Other | Home Situations Questionnaire- Modified for ASD (HSQ-ASD) | Up to 12 Weeks | The HSQ-ASD is a parent-rated scale of child noncompliance. The parent reports on the child's difficulties with compliance in 24 everyday situations. Questions answered affirmatively are then rated on a 1 to 9 Likert scale, with higher scores indicating more severe noncompliance. The scale yields a count of "yes" responses (0 to 27) and a severity score (total of 1 through 9 for all "yes" responses, for a range of 0 to 216 |
| Other | Children's Yale-Brown Obsessive-Compulsive Scales-ASD (CYBOCS-ASD) | Up to 12 Weeks | The CYBOCS-ASD is a modified version of the CYBOCS developed for use in children with Obsessive-Compulsive Disorder. Each item is scored from 0 (least symptomatic) to 4 (most symptomatic), yielding a Total score from 0 to 20. It has established reliability and validity65 and is sensitive to change |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD088528 | A High-dose Folinic Acid Treatment for Core and Associated Symptoms of Autism | FRYE, RICHARD EUGENE | PHOENIX CHILDREN'S HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02839915
GET https://conductscience.org/api/trials/v1/NCT02839915/registered