Encopresis Clinical Trials

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Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

• 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)

• At least one caregiver who speaks and understands English

Locations
United States
Georgia
Marcus Autism Center
RECRUITING
Atlanta
Contact Information
Primary
Mindy Scheithauer, PhD
Mindy.Scheithauer@choa.org
404-785-9322
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2031-01
Participants
Target number of participants: 150
Treatments
Experimental: Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm
* A Board-Certified Behavior Analyst (BCBA) will meet virtually with caregivers for daily appointments for two weeks (goal of 10 appointments; maximum of 2-hours per appointment).~* First appointment, the BCBA will provide support on using telehealth and psychoeducation about encopresis, reinforcement, and suppository use.~* Subsequent appointments involve a scheduled sit on the toilet to encourage an independent bowel movement. If a bowel movement occurs, the caregiver is coached to provide the child with a highly preferred item, praise, and allow them to leave the bathroom. If a bowel movement does not occur, the therapist coaches the parent through administration of a glycerin suppository intended to quickly elicit a bowel movement, followed by another scheduled sit on the toilet.~* After consistent success with continent BMs following suppository administration, the suppository dose will be reduced to gradually fade out its use.
Active_comparator: Parent Education (PE) Arm
* PE includes an initial appointment with a BCBA who will provide recommendations on promoting bowel movement continence.~* First appointment will involve a didactic review of the basics of reinforcement, collecting data to identify when BMs are most likely, and scheduled sits around this time. Caregivers will be instructed to collect data on BMs after this appointment.~* The BCBA will then hold daily follow-up appointments (10 appointments total over 2 weeks). At these appointments, the BCBA will review this data and make additional recommendations (e.g., changing the timing of scheduled sits based on when BMs are most likely to occur, altering the reinforcer used for continent voids) to promote success.
Related Therapeutic Areas
Sponsors
Leads: Emory University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov