Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2026-01-31
2031-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 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.
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.
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.
Interventions
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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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
12 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Emory University
OTHER
Responsible Party
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Mindy Scheithauer
Associate Professor
Principal Investigators
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Mindy Scheithauer, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Marcus Autism Center
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Mindy Scheithauer, PhD
Role: primary
Other Identifiers
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STUDY00010223
Identifier Type: -
Identifier Source: org_study_id