Trial · NCT02383758
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
NCT02383758, Not applicable, Completed, Emory University; results first posted 2018-01-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders. Trials, record NCT02383758. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02383758
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
- NCT number
- NCT02383758
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 22 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Encopresis, Autistic Disorder
- Interventions
- Glycerin Suppository, Bisacodyl suppository, Senna
- First posted
- 2015-03-09
- Last updated
- 2018-07-02
- Results first posted
- 2018-01-11
- Limitations and caveats
This is a pilot trial with a limited sample size. Outcome measure percent change in the number of bowel movements/day was adjusted due to percentage of patients continent due to most participants having no bowel movements at baseline.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Continent | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | The percentage of participant's with continent bowel movements (control of passage of stool from the bowel). |
| Secondary | Percent Independence | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | Percent independence is the percentage of independent bowel movements recorded by a caregiver. A continent bowel movement without the use of any medications will constitute an independent bowel movement. |
| Secondary | Mean Clinical Global Impression for Severity (CGI-S) Score | Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10) | An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients |
| Secondary | Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 6), Post-Intervention (Week 10) | An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Improvement (CGI-I). Clinical Global Impression for Improvement (CGI-I) Scale is a clinician's assessment of a patient's change in condition from baseline.The score ranges from 0 = not assessed, 1 = very much improved, through 7 = very much worse. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Continent | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percent Independence | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Mean Clinical Global Impression for Severity (CGI-S) Score | Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10) | An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis. | units on a scale | MEAN |
| SECONDARY | Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 6), Post-Intervention (Week 10) | An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Continent | Treatment Program | Baseline | 0 | percentage of participants | |
| Percent Continent | Waitlist Control | Baseline | 0 | percentage of participants | |
| Percent Continent | Treatment Program | Post-Intervention (Week 2) | 6 | percentage of participants | |
| Percent Continent | Waitlist Control | Post-Intervention (Week 2) | 0 | percentage of participants | |
| Percent Continent | Treatment Program | Follow Up (Week 4) | 5 | percentage of participants | |
| Percent Continent | Waitlist Control | Follow Up (Week 4) | 0 | percentage of participants | |
| Percent Independence | Treatment Program | Baseline | 0 | percentage of participants | |
| Percent Independence | Waitlist Control | Baseline | 0 | percentage of participants | |
| Percent Independence | Treatment Program | Post-Intervention (Week 2) | 0 | percentage of participants | |
| Percent Independence | Waitlist Control | Post-Intervention (Week 2) | 0 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Program | 10 | |
| Overall Study | STARTED | Waitlist Control | 10 | |
| Overall Study | COMPLETED | Treatment Program | 10 | |
| Overall Study | COMPLETED | Waitlist Control | 8 | |
| Overall Study | NOT COMPLETED | Treatment Program | 0 | |
| Overall Study | NOT COMPLETED | Waitlist Control | 2 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Program | 0 | 10 |
| Total, all-cause mortality | Waitlist Control | 0 | 10 |
| Total, other adverse events | Treatment Program | 0 | 10 |
| Total, other adverse events | Waitlist Control | 0 | 10 |
| Total, serious adverse events | Treatment Program | 0 | 10 |
| Total, serious adverse events | Waitlist Control | 0 | 10 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Program vs Waitlist Control: deaths from any cause | Trial comparisons |
| Treatment Program vs Waitlist Control: 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/NCT02383758
GET https://conductscience.org/api/trials/v1/NCT02383758/results?page=2