Toileting Program for Encopresis

Overseen By Mindy Scheithauer, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Unresolved medical condition, Failed treatment, Serious disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help children with encopresis (involuntary bowel movements) achieve bowel control. It targets autistic youth who have already managed urination control but still struggle with bowel movements. Researchers are testing two methods: one involves a virtual program where a behavior analyst coaches caregivers, and the other educates parents to adjust daily routines. This comprehensive toileting program aims to provide structured support. Children aged 5 to 12 with developmental delays and frequent bowel accidents might be a good fit, especially if they have a caregiver who speaks English. As a Phase 4 trial, this research involves an FDA-approved treatment that has proven effective, aiming to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are undergoing another treatment for incontinence, you may not be eligible to participate.

What is the safety track record for the Comprehensive Toileting Program?

Research has shown that the Comprehensive Toileting Program for encopresis (chronic constipation with leakage) is generally easy for participants to handle. Previous studies on similar programs, which use both medical and behavioral approaches, have not identified any serious side effects or problems from the treatment.

One small study with children who have autism and encopresis demonstrated that the program improved bowel movements without causing significant negative effects. The program often involves caregivers and uses a mix of scheduled bathroom visits and rewards to encourage regular bowel habits. This approach appears safe and manageable for families to use at home, especially with support from therapists through telehealth.

Overall, the program's safety appears favorable based on the available data. Participants in past studies have generally found the program easy to follow, and it has effectively managed symptoms. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these trials for encopresis because they focus on caregiver-mediated interventions that leverage behavioral techniques. The CM-MIE arm is unique as it involves direct coaching from a Board-Certified Behavior Analyst (BCBA) through virtual appointments, where parents are guided in using reinforcement and suppositories during scheduled toilet sits to promote independent bowel movements. In contrast, the Parent Education (PE) arm emphasizes data collection and personalized recommendations to optimize bowel movement timing and reinforce continence. Unlike standard medical treatments such as laxatives or enemas, these approaches aim to empower caregivers with techniques that can lead to sustained behavior change and greater independence for the child.

What evidence suggests that this trial's treatments could be effective for encopresis?

Research has shown that a well-rounded toilet training program, incorporating both behavioral and medical strategies, can help treat encopresis (accidental bowel movements) in children with autism. This trial will compare two approaches: the Caregiver-mediated version of the Multidisciplinary Intervention for Encopresis (CM-MIE) and the Parent Education (PE) program. Studies have found that approaches like the Multidisciplinary Intervention for Encopresis (MIE) reduce accidents at home and school. Specifically, one study found that about 80% of children improved after two years of structured bowel management. Early results suggest that using rewards and setting regular times for toilet sitting increase successful bathroom use. This program shows promise for improving bowel control and reducing accidents. ^{2 6 7 8 9}

Who Is on the Research Team?

Mindy Scheithauer, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for young individuals with Autism Spectrum Disorder who have completed enuresis treatment but still struggle with soiling or encopresis. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Required for pre-randomization phase only: Enuresis (> 1 incontinent urination per day when on a consistent toileting sit schedule)

Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone)

I experience involuntary bowel movements more than once a week.

Exclusion Criteria

I have tried and not succeeded with intensive bathroom training similar to this study in the last 2 years.

I don't have health issues that would prevent toilet training.

I have a serious mental health condition that needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Toilet Training for Enuresis

Participants complete toilet training for enuresis if needed, and are monitored to determine if encopresis persists

Varies

Treatment

Participants with resolved enuresis but persisting encopresis receive either a caregiver-mediated intervention for encopresis or a parent education program, delivered via telehealth

2 weeks

10 virtual appointments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures assessed 5 weeks post-baseline

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Toileting Program

Trial Overview The study tests a caregiver-mediated Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth, comparing its effectiveness in helping maintain fecal continence using glycerin suppositories and behavioral strategies.

How Is the Trial Designed?

Group I: Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm Experimental Treatment 2 Interventions

* 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.

Group II: Parent Education (PE) Arm Active Control 1 Intervention

* 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226739?rank=7

NCT07226739 | Comprehensive Toileting Program Outcomes will include caregiver-completed questionnaires, data on bowel movements collected by the caregiver, and an interview between the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03197922

Treatment of Encopresis in Children With Autism Spectrum ... This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2846588/

Treating Non-Retentive Encopresis with Rewarded ... The results showed an increase in sitting on the toilet and a decline in encopretic episodes in both school and home settings. These findings support the use of ...

4. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1153336.pdf

A Multidisciplinary Intervention for Encopresis in Children with ... The purpose of this study is to demonstrate the efficacy of MIE in a randomized controlled trial with 150 children with ASD. 15. SUBJECT TERMS. Autism Spectrum ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0882596325002131

The outcomes of a structured bowel management ... Long-term follow-ups indicate that after 2 years of care, approximately 80 % of the children achieved recovery. Conclusion. This study highlights the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07226739?term=autistic+disorder

Study Details | NCT07226739 | Comprehensive Toileting ... Outcomes will include caregiver-completed questionnaires, data on bowel movements collected by the caregiver, and an interview between the ...

7. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1203874.pdf

A Multidisciplinary Intervention for Encopresis in Children with ... As described in the SOW, this study evaluated efficacy using three outcome measures: (1.1) rates of continence (defined as no more than one incontinent bowel ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31768718/

A Pilot Randomized Clinical Trial of a Multidisciplinary ... In this pilot trial, 20 children with ASD and encopresis were randomly assigned to multidisciplinary intervention for encopresis (MIE; n = 10) or a waitlist ...

9. researchgate.net researchgate.net/publication/337496417_A_Pilot_Randomized_Clinical_Trial_of_a_Multidisciplinary_Intervention_for_Encopresis_in_Children_with_Autism_Spectrum_Disorder

A Pilot Randomized Clinical Trial of a Multidisciplinary ... In this pilot trial, 20 children with ASD and encopresis were randomly assigned to multidisciplinary intervention for encopresis (MIE; n = 10) ...