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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02383758
• Collaborator: Organization for Autism Research (Other)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Encopresis; Autistic Disorder	Drug: Glycerin Suppository; Drug: Bisacodyl suppository; Drug: Senna	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marcus Autism Center	Atlanta	Georgia	United States	30329

Sponsors and Collaborators

• Emory University
• Organization for Autism Research

Investigators

• Principal Investigator: Nathan Call, PhD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nathan A. Call, Ph.D., BCBA-D, Instructor, Emory University
• ClinicalTrials.gov Identifier: NCT02383758
• Other Study ID Numbers: IRB00076608
• First Posted: Mar 9, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nathan A. Call, Ph.D., BCBA-D, Instructor, Emory University: Behavioral Symptoms; Child Development Disorders, Pervasive; Bowel Incontinence; Constipation
• Additional relevant MeSH terms: Fecal Incontinence; Disease; Encopresis; Autism Spectrum Disorder; Autistic Disorder; Bisacodyl; Glycerol

Study Results

Participant Flow

Recruitment Details	Participants were recruited between February 2015 and January 2017.
Pre-assignment Detail	Of the 22 subjects consented for participation, 20 were randomized to a study intervention and were included in study analyses.

Arm/Group Title	Treatment Program	Waitlist Control
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	8
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Treatment Program	Waitlist Control	Total
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	10 100%	10 100%	20 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	4 40%	4 20%
Male	10 100%	6 60%	16 80%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.

Arm/Group Title	Treatment Program	Waitlist Control
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.
Measure Participants	10	10
Baseline	0 0%	0 0%
Post-Intervention (Week 2)	6 60%	0 0%
Follow Up (Week 4)	5 50%	0 0%

2. Secondary Outcome

Title	Percent Independence
Description	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.
Time Frame	Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)

Outcome Measure Data

Analysis Population Description

An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.

Arm/Group Title	Treatment Program	Waitlist Control
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.
Measure Participants	10	10
Baseline	0 0%	0 0%
Post-Intervention (Week 2)	0 0%	0 0%
Follow Up (week 4)	5 50%	0 0%

3. Secondary Outcome

Title	Mean Clinical Global Impression for Severity (CGI-S) Score
Description	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
Time Frame	Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)

Outcome Measure Data

Analysis Population Description

An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.

Arm/Group Title	Treatment Program	Waitlist Control
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.
Measure Participants	10	10
Baseline	5.4 (.7)	5.2 (.4)
Post-Intervention (Week 6)	5.0 (.9)	5.0 (.5)
Post-Intervention (Week 10)	4.3 (.9)	4.9 (.6)

4. Secondary Outcome

Title	Mean Clinical Global Impression for Improvement (CGI-I) Score
Description	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.
Time Frame	Post-Intervention (Week 6), Post-Intervention (Week 10)

Outcome Measure Data

Analysis Population Description

An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.

Arm/Group Title	Treatment Program	Waitlist Control
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.
Measure Participants	10	10
Post-Intervention (Week 6)	3.0 (.5)	3.8 (.6)
Post-Intervention (Week 10)	2.1 (.9)	3.6 (1.0)

Adverse Events

Time Frame	Adverse events were collected throughout the duration of the study (1 year and 11 months).
Arm/Group Title	Treatment Program		Waitlist Control
Arm/Group Description	Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.		Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent. Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes. Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered. Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began.
All Cause Mortality
	Treatment Program		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Treatment Program		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Program		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.