Treatment of Encopresis in Children With Autism Spectrum Disorders
Condition: Encopresis; Autism Spectrum Disorder
MeSH terms: Fecal Incontinence; Encopresis; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): MIE Treatment; Glycerin Suppository; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Drug; Combination Product
Intervention description(s): Appointments consist of a series of sitting routines (i.e., "sits"). Each sit consists of 10 min on the toilet, followed by 1 min of standing, then repeating the 10 min on the toilet 1 min off, for up to 32 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement.; If no continent bowel movement occurs with the first sit, trained staff administer a dose of a liquid glycerin suppository, immediately followed by another sit to ensure any resulting bowel movement is continent. Glycerin suppositories are replaced by bisacodyl if 2 days pass without a continent bowel movement using the liquid glycerin suppository. Behavioral intervention consists of potent positive reinforcers when a continent bowel movement occurs. As independent continent bowel movements begin to occur, the need for the medical regimen diminishes, and is gradually faded out entirely.; Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group will receive a 2-hour individual appointment in clinic with a doctoral level clinician with extensive experience in behavioral treatments for encopresis. During the appointment, the clinician will review strategies to increase continence by providing parent education on the following topics: how to collect and evaluate data on their child's bowel movements, how to establish and use a sit schedule, identifying behaviors that are precursors to bowel movements and how to use them to increase the probability of a bowel movement being continent, consequences for incontinence, and reinforcement for continence.
Other intervention name(s): Multidisciplinary Intervention for Encopresis
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 56 participants will be assigned to 2 weeks of the Multidisciplinary Intervention for Encopresis (MIE) treatment, 56 will be assigned to treatment as usual (TAU) as a control group. Twenty-six participants were assigned to the study arm with one week of MIE, which has been discontinued.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constipation