Recruiting

CM-MIE

Sponsor:

Emory University

Code:

NCT07226739

Conditions

Encopresis

ASD

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Glycerin Suppository

Behavioral strategies

Study Details

Brief 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.

Conditions

Encopresis

ASD

Study ID

NCT07226739

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Glycerin Suppository

Liquid glycerin suppositories, pediatric (age 2-5 years: 4 ml/applicator) or adult (6-12 years: 7.5ml/applicator) dose used as indicated based on age will be used in the study. Up to two doses will be delivered a day.

The purpose of the glycerin suppository is to rapidly evoke a bowel movement, which allows for a predictable bowel movement to occur while the child is seated on the toilet (a continent bowel movement).

Behavioral strategies

The BCBA will provide recommendations on promoting bowel movement continence. The caregiver will be asked to collect data between visits that will be reviewed by the therapist.

Primary outcome measure

  • Clinical Global Impression Improvement (CGI-I) scale score [ Time Frame: 5 weeks post-baseline (Endpoint) ]

Central Contacts and Locations

Central contacts

Mindy Scheithauer, PhD

404-785-9322Mindy.Scheithauer@choa.org

Locations

Marcus Autism Center

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Mindy Scheithauer, PhD

mindy.scheithauer@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-18.