Comprehensive Toileting Program

Conditions

• ASD
• Encopresis

Eligibility Criteria

Sex

ALL

Age

5 Years - 12 Years

Healthy Volunteers

Not accepted

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).
• 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.

Study Details

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.

Key Dates

Start date

May 31, 2026

Status verified

Apr 2026

Primary completion

Jan 31, 2031

Completion

Jan 31, 2031

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Mindy Scheithauer, PhD
  404-785-9322
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

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