Treatment of Encopresis in Children With Autism Spectrum Disorders

PHASE3CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

October 25, 2017

Primary Completion Date

November 17, 2022

Study Completion Date

November 17, 2022

Conditions
EncopresisAutism Spectrum Disorder
Interventions
BEHAVIORAL

MIE Treatment

"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."

DRUG

Glycerin Suppository

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.

COMBINATION_PRODUCT

Treatment as Usual (TAU)

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.

Trial Locations (1)

30329

Marcus Autism Center, Atlanta

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Emory University

OTHER

NCT03197922 - Treatment of Encopresis in Children With Autism Spectrum Disorders | Biotech Hunter | Biotech Hunter