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An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
NA trial testing Glycerin Suppository in Encopresis in 22 participants. Completed in 1 January 2017.
| Lead sponsor | Emory University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 1 February 2015 |
| Primary completion | 1 January 2017 |
| Estimated completion | 1 January 2017 |
| Sites | 1 location across United States |
Emory University
Adults 5 to 21, any sex, with Encopresis or Autistic Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 0 | |
| Waitlist Control | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 6 | |
| Waitlist Control | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 5 | |
| Waitlist Control | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 0 | |
| Waitlist Control | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 0 | |
| Waitlist Control | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 5 | |
| Waitlist Control | 0 |
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,
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 5.4 | ± .7 |
| Waitlist Control | 5.2 | ± .4 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 5.0 | ± .9 |
| Waitlist Control | 5.0 | ± .5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 4.3 | ± .9 |
| Waitlist Control | 4.9 | ± .6 |
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 r
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 3.0 | ± .5 |
| Waitlist Control | 3.8 | ± .6 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Program | 2.1 | ± .9 |
| Waitlist Control | 3.6 | ± 1.0 |
The purpose of this study is to try to treat bowel movement (BM) accidents differently with children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC) medications to evoke predictable bowel movements. This will make it possible for investigators to use certain strategies to reward BMs in the toilet. Independence will be increased by fading out the use of medications. The investigators will also train caregivers to implement the procedures.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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