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

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.

• 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

• Percent Continent [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

• Percent Independence [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.
• Mean Clinical Global Impression for Severity (CGI-S) Score [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
• Mean Clinical Global Impression for Improvement (CGI-I) Score [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.

Sex: All, ages: 5 Years to 21 Years

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

Participant flow

Outcome results

• Percent Continent (Primary), Number, percentage of participants: Treatment Program 0; Waitlist Control 0
• Percent Independence (Secondary), Number, percentage of participants: Treatment Program 0; Waitlist Control 0
• Mean Clinical Global Impression for Severity (CGI-S) Score (Secondary), Mean, units on a scale: Treatment Program 5.4 +/- .7; Waitlist Control 5.2 +/- .4
• Mean Clinical Global Impression for Improvement (CGI-I) Score (Secondary), Mean, units on a scale: Treatment Program 3.0 +/- .5; Waitlist Control 3.8 +/- .6

Adverse events

Time frame: Adverse events were collected throughout the duration of the study (1 year and 11 months).

Limitations and caveats: This is a pilot trial with a limited sample size. Outcome measure percent change in the number of bowel movements/day was adjusted due to percentage of patients continent due to most participants having no bowel movements at baseline.

• Nathan Call, PhD, Principal investigator, Emory University