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Comprehensive Toileting Program

ConditionsEncopresisASD
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age5-12
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) ArmExperimental treatment 2 interventions
Group B: Parent Education (PE) ArmActive comparator 1 intervention

Trial outcomes

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.

Time frame
5 weeks post-baseline (Endpoint)

Secondary outcomes

1

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

Caregiver Strain Questionnaire-short form (CGSQ-SF) change score at endpoint will be compared between the CM-MIE and the PE group. The Caregiver Strain Questionnaire-short form is a 7-item measure of self-reported strain experienced by caregivers and families, with responses on a 5-point Likert scale. Total possible score range is 7-35, with higher scores indicating higher strain (worse outcome).

Time frame
5 weeks post-baseline (Endpoint)
2

Fecal continence based on caregiver-collected data

Treatment response measured as fecal continence based on caregiver-collected data in a bowel-activity diary that documents all continent and incontinent bowel movements. Number of positive responses will be compared in CM-MIE vs. PE groups.

Time frame
5 weeks post-baseline (Endpoint)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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