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

NCT02383758 | Completed Results FDA Drug

• 1 other identifier: IRB00076608
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Encopresis; Autistic Disorder

Keywords

Behavioral Symptoms; Child Development Disorders, Pervasive; Bowel Incontinence; Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent Independence

  Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)

• Mean Clinical Global Impression for Severity (CGI-S) Score

  Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)

• Mean Clinical Global Impression for Improvement (CGI-I) Score

  Post-Intervention (Week 6), Post-Intervention (Week 10)

Study Arms (2)

Treatment Program

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.

Drug: Glycerin Suppository; Drug: Bisacodyl suppository; Drug: Senna

Waitlist Control

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.

Drug: Glycerin Suppository; Drug: Bisacodyl suppository; Drug: Senna

Interventions

Glycerin Suppository DRUG

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.

Treatment Program; Waitlist Control

Bisacodyl suppository DRUG

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.

Treatment Program; Waitlist Control

Senna DRUG

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.

Treatment Program; Waitlist Control

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Organization for Autism Research: collaborator

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Encopresis; Autistic Disorder; Behavioral Symptoms; Child Development Disorders, Pervasive; Fecal Incontinence; Constipation

Interventions

Sennosides

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Elimination Disorders; Mental Disorders; Autism Spectrum Disorder; Neurodevelopmental Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Limitations and 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.

Results Point of Contact

• Title: Dr. Nathan Call
• Organization: Emory University

nathan.call@choa.org

Study Officials

• Nathan Call, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 2, 2018
• Results First Posted: January 11, 2018

Record last verified: 2018-05

Locations

US (1)