Comprehensive Toileting Program
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-12
SponsorEmory University
About this trial
The current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to determine efficacy in a randomized clinical trial.
Eligibility criteria
Qualifiers
Age 5 to 12
Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone)
Encopresis (more than 1 incontinent BM a week)
Required for pre-randomization phase only: Enuresis (> 1 incontinent urination per day when on a consistent toileting sit schedule)
Disqualifiers
Unresolved medical condition that would impede toilet training (e.g., interference with sphincter control, short gut syndrome, urinary tract or gastrointestinal infection, unexplained diarrhea, recent intestinal surgery, inflammatory bowel disease)
Failed intensive toileting treatment in the past 2 yrs with protocols akin to study
Current serious behavioral or psychiatric disorder that requires another treatment
Current or planned other intervention (behavioral or medical) for incontinence
Trial design
Treatments tested in this trial
- Glycerin Suppository
- Behavioral strategies
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov