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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: A large percentage of individuals with autism spectrum disorder (ASD) are delayed in achieving continence with bowel movements or never achieve it at all (i.e., they meet criteria for encopresis). This problem has tremendous ramifications for these individuals and their families because encopresis restricts them from integration with peers, limits access to educational opportunities, and carries significant social stigma. Previous interventions for encopresis in this population have either been unsuccessful or required implementation over very long periods.
Sponsor: Emory University

Current Primary Outcome: Efficacy, measured by frequency of continent bowel movements recorded by primary caregiver [ Time Frame: Four weeks post-intervention ]

Each participant's primary caregiver(s) will be asked to collect data on the frequency of bowel movements and whether they are continent for four weeks prior to treatment, throughout the 2 weeks of intervention, and for four weeks after treatment. Caregivers of children randomly assigned to the control group will also record data throughout the waitlist period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Independence, measured by number of independent bowel movement recorded by caregiver [ Time Frame: Four weeks post-intervention ]
    Caregivers will record whether medical intervention was required to elicit any bowel movements, and if so, what level of medication. A continent bowel movement without the use of any medications will constitute an independent bowel movement.
  • Parent target problem (PTP), measured by Clinical Global Impression for Severity (CGI-S) [ Time Frame: 4 weeks post intervention ]
    An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: February 25, 2015
Date Started: February 1, 2015
Date Completion:
Last Updated: April 12, 2017
Last Verified: April 2017