An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders

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.

Study Overview

• Status: Completed
• Conditions: Autistic Disorder; Encopresis
• Intervention / Treatment: Drug: Glycerin Suppository; Drug: Bisacodyl suppository; Drug: Senna

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Marcus Autism Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Program; 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.	Drug: 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.; Drug: 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.; Drug: 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: Waitlist Control; 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.	Drug: 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.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Continent	The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).	Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Independence	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.	Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Mean Clinical Global Impression for Severity (CGI-S) Score	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	Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)
Mean Clinical Global Impression for Improvement (CGI-I) Score	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.	Post-Intervention (Week 6), Post-Intervention (Week 10)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Organization for Autism Research
• Investigators: Principal Investigator: Nathan Call, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Constipation; Behavioral Symptoms; Bowel Incontinence; Child Development Disorders, Pervasive
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Pathologic Processes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Elimination Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Fecal Incontinence; Encopresis; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Cathartics; Laxatives; Cryoprotective Agents; Bisacodyl; Glycerol
• Other Study ID Numbers: IRB00076608

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No