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

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

Interventions

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.

Sponsors & Collaborators

• Organization for Autism Research

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Nathan Call, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-01

Primary Completion

2017-01-01

Completion

2017-01-01

FDA Drug

Yes

Countries

• United States

Study Locations