Treatment of Encopresis in Children With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title: A Multidisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders

Status Completed

Clinical Trial Summary

This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential medical complications. Following this, caregivers collect data on bowel movements and continence during a home baseline lasting no less than 14 days and no more than 21 days. Participants randomly assigned to treatment as usual or the treatment group, and begin attending daily appointments in clinic for 2 weeks. At appointments, the behavior team implements structured sits on the toilet to promote independent bowel movements (BMs). If an independent BM does not occur, the study team will administer a suppository to promote rapid release of the bowels and prompt the child to remain on the toilet following administration. In doing so, continent bowel movements are predictably evoked while the child is on the toilet, allowing for reinforcement with praise and preferred toys/activities. Eventually, suppositories are gradually decreased until the child is having BMs independently. Caregivers are trained to continue implementing the intervention following the clinic-based portion.

The purpose of the current study is to evaluate MIE using a large randomized clinical trial (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The researchers will recruit 112 children diagnosed with ASD, randomizing them to two weeks of MIE, or treatment as usual (TAU) consisting of behavioral consultation and medical intervention. This study will evaluate MIE compared to TAU and determine the optimal treatment length.

Clinical Trial Description

Toilet training one's child is a nearly universal challenge for parents, but is a particularly distressing ordeal for parents of individuals with autism spectrum disorder (ASD). Whereas typically developing children generally stop having daytime toileting accidents (i.e., they achieve continence) by 2-4 years of age, most individuals with ASD are either delayed in their acquisition of toileting skills, or never achieve continence. Furthermore, toileting concerns are a significant contributor to the increased stress experienced by caregivers of those with ASD. Besides dramatically increasing their burden of care, not being fully toilet trained negatively impacts the individual with ASD's hygiene, self-confidence, physical comfort, and independence while also causing social stigma. Incontinence can also have serious collateral consequences, such as limiting exposure to important life experiences. Furthermore, without effective treatment these problems generally persist into adulthood.

One reason why strictly behavioral treatments of encopresis have shown only limited success may be due to the fact that it often has a medical etiology. Encopresis is when underwear are soiled by stool in children over the age of toilet training and long-standing constipation is the cause of encopresis in the majority of children who exhibit it. Children with ASD are more likely to have constipation than typically developing children. Constipation causes encopresis by creating a cycle of withholding bowel movements (withholding is the voluntary contraction of the external sphincter to avoid a bowel movement): constipation causes painful bowel movements, which triggers further withholding behavior, exacerbating constipation. Over time the colon adapts by dilating, which leads to larger fecal masses in the rectum. Thus, the passage of larger and harder (i.e., painful) stools further increases an individual's withholding behavior. Over time, the rectum and colon become so dilated that the individual loses sensation. With no urge to defecate, an individual is even more likely to have stool accumulate in the rectum and is also unable to control bowel movements. Looser stool may leak around hard stool leading to an unintended leakage and sometimes large evacuation of stool occurs without the individual realizing it.

Although purely medical approaches can successfully treat constipation in individuals with ASD, they have not shown long term success with encopresis. That is, medical approaches can treat a single episode of constipation, but without acquiring toileting skills, the individual is likely to become constipated again, repeating the cycle. Conversely, purely behavioral strategies have not been shown to be effective at treating encopresis in individuals with ASD, even when they are not experiencing constipation. One reason for this lack of success may have to do with the fact that it is often difficult to predict the timing of a bowel movement so that caregivers can ensure the individual is sitting on the toilet when one takes place and then reinforce continence. Thus, a multidisciplinary approach incorporating both medical and behavioral approaches is necessary in the treatment of encopresis in individuals with ASD.

This is an 8-week, randomized clinical trial of 112 children, ages 5 to 12 years, 11 months with ASD and encopresis. Participants will be randomized to receive either two weeks of MIE or one week of TAU. The study initially had a third study arm of one week of MIE treatment, which was discontinued in October of 2019. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Encopresis
• Fecal Incontinence

• NCT number: NCT03197922
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: Phase 3
• Start date: October 25, 2017
• Completion date: November 17, 2022