Comprehensive Toileting Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glycerin Suppository, Behavioral strategies.
- Who it may be relevant to
- Registry conditions: Encopresis, ASD. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis
Overview
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.
Interventions
- Drug Glycerin Suppository
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 Behavioral strategies
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.
Primary outcome measures
- Clinical Global Impression Improvement (CGI-I) scale score [Time frame: 5 weeks post-baseline (Endpoint)]
Secondary outcome measures (2)
- Caregiver Strain Questionnaire-short form (CGSQ-SF) score [Time frame: 5 weeks post-baseline (Endpoint)]
- Fecal continence based on caregiver-collected data [Time frame: 5 weeks post-baseline (Endpoint)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Marcus Autism Center — Atlanta
Identifiers
NCT: NCT07226739 · STUDY00010223 · 1R01HD115933-01A1 · 2025P012749