Marcus Autism Center
Atlanta, Georgia, 30329, United States
Location status: Recruiting
NCT Number: NCT07226739
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.
Interested in participating?
Request Info5 year–12 year
All sexes
Interventional
Phase 4
Atlanta, Georgia, 30329, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: MAJOR® Glycerin
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.
Time frame: 5 weeks post-baseline (Endpoint)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Emory University
Other
Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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