Trial · NCT03008889
A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder
NCT03008889, Phase 2, Completed, Emory University; results first posted 2020-12-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder. Trials, record NCT03008889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03008889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder
- NCT number
- NCT03008889
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Autism Spectrum Disorder
- Interventions
- N-acetylcysteine, Placebo
- First posted
- 2017-01-04
- Last updated
- 2021-01-26
- Results first posted
- 2020-12-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Randomized | 12 months (throughout the duration of the study) | Goal: randomize 1.75 participants per month |
| Primary | Attrition Rate | 12 months (throughout the duration of the study) | Attrition rate is defined as the percent of subjects who did not complete the study. Goal:less than 15% (to indicate that study was acceptable to participants and parents). |
| Primary | Study Medication Compliance | 12 months (throughout the duration of the study) | Goal: at least 70% treatment compliance (tablet counts and drug dairies). |
| Primary | Successful Collection of Outcome Measures | 12 months (throughout the duration of the study) | Goal: at least 80% collection of essential outcome data to demonstrate the feasibility of data collection procedures. |
| Primary | Parent Satisfaction Rating | Week 9 (at the end of the study intervention) | Goal: at least 80% of parents will agree or strongly agree when asked in an anonymous survey that they would recommend the study and the study treatment to other parents of children with ASD and SIB. |
| Secondary | Positive Predictive Value of Screening Method of Classifying Self-injurious Behavior (SIB) by Type. | 12 months (duration of the study) | Goal: at least 75% positive predictive value of our screening method to classify children with automatically maintained self-injurious behavior using a semi-structured interview at screening compared to the findings of five- to six-hour functional analysis at baseline. Only children who appear to have automatically maintained SIB will be referred for the baseline evaluation. Demonstrating a high positive predictive value for the screening method is a necessary prerequisite for launching a larger study. Using the formula: Positive Predictive Value (PPV) = screen positive and true cases ÷ all positive screens, a value of 75% or greater would indicate success of the screening method used. |
| Secondary | Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention | Baseline, Week 9 | The Aberrant Behavior Checklist (ABC) is a commonly used 58-item parent-rated measure of overall behavioral problems. The Irritability subscale is comprised of 15 items reflecting tantrums, aggression and self injury. Range is 0 to 45, higher scores indicate higher severity. As a preliminary efficacy outcome, it was calculated the average score at baseline and Week 9 post-intervention. |
| Secondary | Number of Self-Injurious Behavior Events | Baseline, Week 9 | Direct observation of the frequency of SIB was collected at baseline in a separate observational session after completing the functional analysis and again at Week 9. Investigators set a benchmark of an average decline in the frequency of SIB of 50% within the NAC group. |
| Secondary | Change in Clinical Global Impression (CGI-I) Scale at 9 Weeks Post-intervention | Week 9 | The Clinical Global Impression (CGI-I) scale is a 7-item scale from 1 (Very Much Improved) through 4 (No Change) to 7 (Very Much Worse). By convention, scores of 2 (Much Improved) or 1 (Very Much Improved) are used to define positive response. |
| Secondary | Change in Biomarkers and Possible Mechanisms of Action of NAC in Children With ASD. | Baseline, Week 9 | Changes amino acid levels before and after NAC treatment: cysteine/cystine and glutathione/glutathione disulfide (GSH/GSSG) ratios (antioxidant effects), glutamate and glutamate/glutamine ratio (glutamate signaling) and GABA levels. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Randomized | 12 months (throughout the duration of the study) | percentage of participants randomized | NUMBER | |
| PRIMARY | Attrition Rate | 12 months (throughout the duration of the study) | percentage of participants | NUMBER | |
| PRIMARY | Study Medication Compliance | 12 months (throughout the duration of the study) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Successful Collection of Outcome Measures | 12 months (throughout the duration of the study) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Parent Satisfaction Rating | Week 9 (at the end of the study intervention) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Positive Predictive Value of Screening Method of Classifying Self-injurious Behavior (SIB) by Type. | 12 months (duration of the study) | Screening method for classifying self-injurious behavior (SIB) happened before randomization. Of the 8 participants that consented, one was excluded due to asthma. Results show participants that were classified with repetitive SIB. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention | Baseline, Week 9 | score on a scale | NUMBER | |
| SECONDARY | Number of Self-Injurious Behavior Events | Baseline, Week 9 | Self injurious events | NUMBER | |
| SECONDARY | Change in Clinical Global Impression (CGI-I) Scale at 9 Weeks Post-intervention | Week 9 | score on a scale | NUMBER | |
| SECONDARY | Change in Biomarkers and Possible Mechanisms of Action of NAC in Children With ASD. | Baseline, Week 9 | Blood samples were collected and processed in accordance with the protocol. In consultation with our biochemist collaborator, we did not proceed with the multiple laboratory procedures to analyze the sample. Our collaborator indicated that the findings would not be interpretable because we only had two subjects. |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Randomized | Participants Taking NAC | 100 | percentage of participants randomized | ||
| Percentage of Participants Randomized | Participants Taking Placebo | 100 | percentage of participants randomized | ||
| Attrition Rate | Participants Taking NAC | 0 | percentage of participants | ||
| Attrition Rate | Participants Taking Placebo | 0 | percentage of participants | ||
| Study Medication Compliance | Participants Taking NAC | 1 | Participants | ||
| Study Medication Compliance | Participants Taking Placebo | 1 | Participants | ||
| Successful Collection of Outcome Measures | Participants Taking NAC | 1 | Participants | ||
| Successful Collection of Outcome Measures | Participants Taking Placebo | 1 | Participants | ||
| Parent Satisfaction Rating | Participants Taking NAC | 1 | Participants | ||
| Parent Satisfaction Rating | Participants Taking Placebo | 1 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Taking NAC | 1 | |
| Overall Study | STARTED | Participants Taking Placebo | 1 | |
| Overall Study | COMPLETED | Participants Taking NAC | 1 | |
| Overall Study | COMPLETED | Participants Taking Placebo | 1 | |
| Overall Study | NOT COMPLETED | Participants Taking NAC | 0 | |
| Overall Study | NOT COMPLETED | Participants Taking Placebo | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Early morning awakening | General disorders | Participants Taking NAC | 1 | 1 | 1 |
| other | Early morning awakening | General disorders | Participants Taking Placebo | 0 | 1 | 0 |
| other | Drowsiness | General disorders | Participants Taking NAC | 1 | 1 | 1 |
| other | Drowsiness | General disorders | Participants Taking Placebo | 0 | 1 | 0 |
| other | Fever | General disorders | Participants Taking NAC | 1 | 1 | 1 |
| other | Fever | General disorders | Participants Taking Placebo | 0 | 1 | 0 |
| other | Rhinitis | Infections and infestations | Participants Taking NAC | 1 | 1 | 1 |
| other | Rhinitis | Infections and infestations | Participants Taking Placebo | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | Participants Taking NAC | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | Participants Taking Placebo | 1 | 1 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Taking NAC | 0 | 1 |
| Total, all-cause mortality | Participants Taking Placebo | 0 | 1 |
| Total, other adverse events | Participants Taking NAC | 1 | 1 |
| Total, other adverse events | Participants Taking Placebo | 1 | 1 |
| Total, serious adverse events | Participants Taking NAC | 0 | 1 |
| Total, serious adverse events | Participants Taking Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Participants Taking NAC vs Participants Taking Placebo: Successful Collection of Outcome Measures | Trial comparisons |
| Participants Taking NAC vs Participants Taking Placebo: Parent Satisfaction Rating | Trial comparisons |
| Participants Taking NAC vs Participants Taking Placebo: Study Medication Compliance | Trial comparisons |
| Participants Taking NAC vs Participants Taking Placebo: deaths from any cause | Trial comparisons |
| Participants Taking NAC vs Participants Taking Placebo: serious adverse events | Trial comparisons |
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/NCT03008889
GET https://conductscience.org/api/trials/v1/NCT03008889/results?page=2