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
Intervention: MIE Treatment; Glycerin Suppository; Treatment as Usual (TAU)
Intervention description: 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.
Intervention MeSH terms: Glycerol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: Outcome measures, including the Parent-nominated Target Problem (PTP), will be conducted by separate independent evaluators (IE) each of who are blind to treatment assignment.
Enrollment: 117.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Constipation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females from 5 years of age to 12 years 11 months of age.

          -  Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Autism
             Spectrum Disorder as established by clinical assessment, corroborated by the Autism
             Diagnostic Observational Schedule, Autism Diagnostic Interview-Revised and/or
             Childhood Autism Rating Scale-Second Edition.

          -  Fewer than 60% of days are continent days or more than 1 day out of 7 is an
             incontinent day over the previous 7 days (a continent day is defined as a day with at
             least one continent bowel movement. An incontinent day is a day with an incontinent
             bowel movement regardless of whether a continent bowel movement also occurs).

          -  Medication free or on stable medication (no changes in past 6 weeks and no planned
             changes for the next 6 months).

          -  Urine continent - Over half of the voids are continent when the child is with the
             parent and when the child is on a typical toileting routine.

        Exclusion Criteria:

          -  Presence of a known medical condition in the child (based on medical history or
             physical examination) that would interfere with child's ability to control his/her
             anus. These include: history of any anal surgery, spinal dysraphism (e.g., spina
             bifida), other neurologic disorder affecting anal function, and prolonged/recurrent
             gastrointestinal infectious disease (e.g. Clostridium difficile colitis). In addition,
             the following may constitute exclusions following evaluation by a physician:
             inflammatory bowel disease, short gut syndrome, chronic diarrhea, or history of
             intestinal/abdominal surgery.

          -  Presence of a current serious behavioral problem or psychiatric condition that would
             require another treatment (e.g., psychotic disorder, major depression, moderate or
             greater aggression, severe disruptive behavior), based on information collected at
             screening and the Behavior Problems Inventory-01 (BPI-01).

          -  Currently receiving and caregiver refusal to discontinue ongoing behavioral or
             alternative medical intervention for encopresis.