Comprehensive Toileting Program for Encopresis in Autistic Youth

This study is for children aged 5 to 12 with an intellectual or developmental delay (excluding ADHD alone) and encopresis (fecal incontinence more than once a week). It aims to see if a program delivered via telehealth can help children who continue to experience encopresis after achieving urine continence. The program involves behavioral strategies and, if needed, liquid glycerin suppositories. Participants will first complete toilet training for urine continence. If encopresis continues, they will either receive the encopresis treatment or a parent education program. A pediatric gastroenterologist will also be involved to ensure safety and manage constipation. The study will measure success by looking at improvements in a clinical global impression scale after 5 weeks. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 150 participants. After an initial phase, participants will be randomly assigned to receive either the encopresis treatment or a parent education program.
What's involved
You would participate in toilet training for urine continence if needed. If encopresis persists, you would receive either a telehealth treatment or a parent education program, and meet with a pediatric gastroenterologist. Caregivers will collect data between visits.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be measured at 5 weeks post-baseline.

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NCT07226739

Comprehensive Toileting Program

Recruiting
PHASE4Ages 5–12InterventionalTreatment
Emory University
~150 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Glycerin SuppositoryBehavioral strategies

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Global Impression Improvement (CGI-I) scale score
Measured over 5 weeks post-baseline (Endpoint)
Encopresis
ASD

NCT07226739

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Marcus Autism Center

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Mindy Scheithauer, PhD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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
  • Clinical Global Impression Improvement (CGI-I) scale score5 weeks post-baseline (Endpoint)

    The CGI-I is a clinician-rated 7-point scale measuring overall change from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse), rated by the treatment-blind independent evaluator (IE) with all available information. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) will define positive response; all other ratings are defined as nonresponders. Number of positive responses for the Clinical Global Impression scale will be compared between the CM-MIE and the PE group.