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

Primary Purpose

Encopresis, Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glycerin Suppository
Bisacodyl suppository
Senna
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Encopresis focused on measuring Behavioral Symptoms, Child Development Disorders, Pervasive, Bowel Incontinence, Constipation

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marcus Autism Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Program

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent Continent
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
February 25, 2015
Last Updated
May 31, 2018
Sponsor
Emory University
Collaborators
Organization for Autism Research
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1. Study Identification

Unique Protocol Identification Number
NCT02383758
Brief Title
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Official Title
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Organization for Autism Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encopresis, Autistic Disorder
Keywords
Behavioral Symptoms, Child Development Disorders, Pervasive, Bowel Incontinence, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glycerin Suppository
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bisacodyl suppository
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Senna
Intervention Description
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 Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Call, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcus Autism Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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