Overview

This trial is active, not recruiting.

Conditions encopresis, autistic disorder
Treatments glycerin suppository, bisacodyl suppository, senna
Sponsor Emory University
Collaborator Organization for Autism Research
Start date February 2015
End date January 2017
Trial size 22 participants
Trial identifier NCT02383758, IRB00076608

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Pediatric subjects with autistic spectrum disorder will begin treatment immediately. The treatment program will consist of 10 appointments of up to 4 hours each, over a 14 day period, followed by 4 weekly 1-hour follow-up visits. During each appointment, subjects will be guided to sit on the toilet. If the participant has a continent urination they will be provided with praise and remain on the toilet. If a participant has a continent bowel movement they will be provided with enthusiastic praise along with positive reinforcement and they will be allowed to leave the bathroom. A continent bowel movement will end that day's appointment. If necessary, glycerin suppositories, bisacodyl suppositories, and/or senna may be used to aid in the bowl movement.
glycerin suppository
Nursing staff will administer one glycerin suppository in the bathroom if there is no continent bowl movement in the first 30 minutes. Subjects will be taken to the bathroom 5 minutes after the suppository is administered for a 30 minute sit or until a continent void occurs. If continent bowel movements maintain on two subsequent days (after bisacodyl suppositories are discontinued) the glycerin suppository will be discontinued. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
bisacodyl suppository
If a subject does not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they will be given a 1 hour break, after which a bisacodyl suppository will be administered. The participant will then sit for an additional 30 minutes.If continent bowel movements maintain for two subsequent days (after senna is discontinued) bisacodyl suppositories will be discontinued if it was required. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
senna
If no continent bowel movements occur for two consecutive treatment days, caregivers will be asked to administer senna each evening thereafter until medication tapering begins. Once there have been two successive days with continent bowel movements, senna will be removed from the intervention if it was required.
(Active Comparator)
Pediatric subjects with autistic spectrum disorder will wait for 8 weeks and then be offered treatment at that time.The treatment program will consist of 10 appointments of up to 4 hours each, over a 14 day period, followed by 4 weekly 1-hour follow-up visits. During each appointment, participants will be guided to sit on the toilet. If the participant has a continent urination they will be provided with praise and remain on the toilet. If a participant has a continent bowel movement they will be provided with enthusiastic praise along with positive reinforcement and they will be allowed to leave the bathroom. A continent bowel movement will end that day's appointment. If necessary, glycerin suppositories, bisacodyl suppositories, and/or senna may be used to aid in the bowl movement.
glycerin suppository
Nursing staff will administer one glycerin suppository in the bathroom if there is no continent bowl movement in the first 30 minutes. Subjects will be taken to the bathroom 5 minutes after the suppository is administered for a 30 minute sit or until a continent void occurs. If continent bowel movements maintain on two subsequent days (after bisacodyl suppositories are discontinued) the glycerin suppository will be discontinued. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
bisacodyl suppository
If a subject does not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they will be given a 1 hour break, after which a bisacodyl suppository will be administered. The participant will then sit for an additional 30 minutes.If continent bowel movements maintain for two subsequent days (after senna is discontinued) bisacodyl suppositories will be discontinued if it was required. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
senna
If no continent bowel movements occur for two consecutive treatment days, caregivers will be asked to administer senna each evening thereafter until medication tapering begins. Once there have been two successive days with continent bowel movements, senna will be removed from the intervention if it was required.

Primary Outcomes

Measure
Efficacy, measured by frequency of continent bowel movements recorded by primary caregiver
time frame: Four weeks post-intervention

Secondary Outcomes

Measure
Independence, measured by number of independent bowel movement recorded by caregiver
time frame: Four weeks post-intervention
Parent target problem (PTP), measured by Clinical Global Impression for Severity (CGI-S)
time frame: 4 weeks post intervention

Eligibility Criteria

Male or female participants from 5 years up to 21 years old.

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

Additional Information

Official title An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Principal investigator Nathan Call, PhD
Description A large percentage of individuals with autism spectrum disorder (ASD) are delayed in achieving continence with bowel movements or never achieve it at all (i.e., they meet criteria for encopresis). This problem has tremendous ramifications for these individuals and their families because encopresis restricts them from integration with peers, limits access to educational opportunities, and carries significant social stigma. Previous interventions for encopresis in this population have either been unsuccessful or required implementation over very long periods.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Emory University.