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Completed

NCT Number: NCT02383758

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

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.

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Key information

Conditions

Encopresis Autism Spectrum Disorder Autistic Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Constipation Digestive System Diseases Elimination Disorders Fecal Incontinence Gastrointestinal Diseases Intestinal Diseases Mental Disorders Neurodevelopmental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marcus Autism Center

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 5-21
  • Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII)
  • Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna
  • Caregiver willing to give consent/assent

Exclusion criteria

  • Age under 5 year or over 21 years
  • Does not present a diagnosis of autistic spectrum disorder
  • Previous intestinal surgeries or concurrent enuresis
  • Caregiver unwilling to give consent/assent

Treatment and study plan

Glycerin Suppository

Drug

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.

Bisacodyl suppository

Drug

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.

Senna

Drug

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.

Primary outcomes

  1. Percent Continent

    Time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)

    The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).

Secondary outcomes

  1. Percent Independence

    Time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)

    Percent independence is the percentage of independent bowel movements recorded by a caregiver. A continent bowel movement without the use of any medications will constitute an independent bowel movement.

  2. Mean Clinical Global Impression for Severity (CGI-S) Score

    Time frame: Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)

    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

  3. Mean Clinical Global Impression for Improvement (CGI-I) Score

    Time frame: Post-Intervention (Week 6), Post-Intervention (Week 10)

    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 Improvement (CGI-I). Clinical Global Impression for Improvement (CGI-I) Scale is a clinician's assessment of a patient's change in condition from baseline.The score ranges from 0 = not assessed, 1 = very much improved, through 7 = very much worse.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Organization for Autism Research

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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