Comprehensive Toileting Program

NCT07226739 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 3 other identifiers: STUDY000102231R01HD115933-01A12025P012749
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

ASD; Encopresis

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Improvement (CGI-I) scale score

  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.

  5 weeks post-baseline (Endpoint)

Secondary Outcomes (2)

• Caregiver Strain Questionnaire-short form (CGSQ-SF) score

  5 weeks post-baseline (Endpoint)

• Fecal continence based on caregiver-collected data

  5 weeks post-baseline (Endpoint)

Study Arms (2)

Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm

EXPERIMENTAL

* 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.

Drug: Glycerin Suppository; Behavioral: Behavioral strategies

Parent Education (PE) Arm

ACTIVE COMPARATOR

* 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.

Behavioral: Behavioral strategies

Interventions

Glycerin Suppository DRUG

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).

Also known as: MAJOR® Glycerin

Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm

Behavioral strategies BEHAVIORAL

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.

Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm; Parent Education (PE) Arm

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Emory University: lead

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Mindy Scheithauer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mindy Scheithauer, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded independent evaluator will conduct the Clinical Global Impression scale.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be submitted via the time standards set forth by NDA.
• Access Criteria: Access to data for research purposes will be provided through an NDA Data Access Committee (DAC). Investigators and institutions seeking data from NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification, which is cosigned by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA).

Locations

US (1)