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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Comprehensive Toileting Program
At a glance
Conditions
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.
Study leadership
- Mindy Scheithauer, PhD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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.