N/A
N=20
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Encopresis · Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02383758 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Percent Continent — 0; 0; 6; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glycerin Suppository (Drug); Bisacodyl suppository (Drug); Senna (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Continent |
0; 0; 6; 0; 5; 0 | — |
| SECONDARY Percent Independence |
0; 0; 0; 0; 5; 0 | — |
| SECONDARY Mean Clinical Global Impression for Severity (CGI-S) Score |
5.4; 5.2; 5.0; 5.0; 4.3; 4.9 | — |
| SECONDARY Mean Clinical Global Impression for Improvement (CGI-I) Score |
3.0; 3.8; 2.1; 3.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age 5-21
- Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII)
- Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna
- Caregiver willing to give consent/assent
Exclusion Criteria
- Age under 5 year or over 21 years
- Does not present a diagnosis of autistic spectrum disorder
- Previous intestinal surgeries or concurrent enuresis
- Caregiver unwilling to give consent/assent
Data sourced from ClinicalTrials.gov (NCT02383758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.