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NCT07226739PHASE4Recruiting

Comprehensive Toileting Program

Emory University

Start Date

6/1/2026

Completion Date

1/1/2031

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.

Detailed Description

Participants will complete toilet training for enuresis (if needed) and then monitored to determine if encopresis persists. For individuals with resolved enuresis but persisting encopresis, they will be randomized to receive either a treatment for encopresis (delivered via telehealth) or a parent education program. The encopresis intervention involves behavioral components and administration of an over-the-counter suppository as needed. All participants will also meet with a pediatric gastroenterologist to ensure safety of study procedures and to resolve constipation as needed. Outcomes will include caregiver-completed questionnaires, data on bowel movements collected by the caregiver, and an interview between the participant's caregiver and a blinded investigator focused on encopresis, other presenting concerns, and any potential adverse events. Informed consent will be collected via signature from one legal guardian. The investigators will collect assent from participants when appropriate given age and developmental level.

Eligibility Criteria

Age Range: 5 years to 12 years

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

Interventions

DRUG

Glycerin Suppository

BEHAVIORAL

Behavioral strategies

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Conditions

EncopresisASD

Locations

Marcus Autism Center

Atlanta, Georgia 30329

United States