Treatment of Encopresis in Children With Autism Spectrum Disorders

NCT03197922 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB00095849
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

This study is comparing a multidisciplinary intervention for encopresis (MIE), consisting of both medical and behavioral components to treatment as usual control (TAU). Participants are first screened by a pediatric gastroenterologist and assessed and treated for any constipation or other potential medical complications. Following this, caregivers collect data on bowel movements and continence during a home baseline lasting no less than 14 days and no more than 21 days. Participants randomly assigned to treatment as usual or the treatment group, and begin attending daily appointments in clinic for 2 weeks. At appointments, the behavior team implements structured sits on the toilet to promote independent bowel movements (BMs). If an independent BM does not occur, the study team will administer a suppository to promote rapid release of the bowels and prompt the child to remain on the toilet following administration. In doing so, continent bowel movements are predictably evoked while the child is on the toilet, allowing for reinforcement with praise and preferred toys/activities. Eventually, suppositories are gradually decreased until the child is having BMs independently. Caregivers are trained to continue implementing the intervention following the clinic-based portion. The purpose of the current study is to evaluate MIE using a large randomized clinical trial (RCT), addressing the Department of Defense Autism Research Program, Area of Interest of Therapies to Alleviate Conditions Co-Occurring with autism spectrum disorder (ASD). The researchers will recruit 112 children diagnosed with ASD, randomizing them to two weeks of MIE, or treatment as usual (TAU) consisting of behavioral consultation and medical intervention. This study will evaluate MIE compared to TAU and determine the optimal treatment length.

Conditions

Encopresis; Autism Spectrum Disorder

Keywords

Constipation

Outcome Measures

Primary Outcomes (1)

• Percentage of Continent Bowel Movements

  The percentage to continent bowel movements, based on parent report during the prior 7 day period, are reported for Baseline and the end of treatment at Week 8.

  Baseline, Week 8

Secondary Outcomes (5)

• Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score

  Week 8

• Parenting Stress Index Short Form Total Score

  Baseline, Week 8

• Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score

  Baseline, Week 8

• Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score

  Baseline, Week 8

• Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score

  Baseline, Week 8

Study Arms (3)

MIE Treatment for Two Weeks

EXPERIMENTAL

Participants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for two weeks. MIE consists of daily clinic appointments, each of which lasts until a continent bowel movement occurs or 3 hours elapse. These participants will discontinue the use of medication previously prescribed for the treatment of constipation, other than the suppositories used in the MIE treatment. During MIE, medical professionals resolve any constipation and oversee a regimen of over the counter medications that increase the predictability of a bowel movement.

Behavioral: MIE Treatment; Drug: Glycerin Suppository

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. Additionally, participants in the TAU group will receive a 2-hour long individual appointment with a doctoral level clinician with extensive experience in behavioral treatments for encopresis.

Combination Product: Treatment as Usual (TAU)

MIE Treatment for One Week

EXPERIMENTAL

Participants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for one week. This study arm was discontinued in October 2019.

Behavioral: MIE Treatment; Drug: Glycerin Suppository

Interventions

MIE Treatment BEHAVIORAL

Appointments consist of a series of sitting routines (i.e., "sits"). Each sit consists of 10 min on the toilet, followed by 1 min of standing, then repeating the 10 min on the toilet 1 min off, for up to 32 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement.

Also known as: Multidisciplinary Intervention for Encopresis

MIE Treatment for One Week; MIE Treatment for Two Weeks

Glycerin Suppository DRUG

If no continent bowel movement occurs with the first sit, trained staff administer a dose of a liquid glycerin suppository, immediately followed by another sit to ensure any resulting bowel movement is continent. Glycerin suppositories are replaced by bisacodyl if 2 days pass without a continent bowel movement using the liquid glycerin suppository. Behavioral intervention consists of potent positive reinforcers when a continent bowel movement occurs. As independent continent bowel movements begin to occur, the need for the medical regimen diminishes, and is gradually faded out entirely.

MIE Treatment for One Week; MIE Treatment for Two Weeks

Treatment as Usual (TAU) COMBINATION_PRODUCT

Participants randomized to the Treatment as Usual (TAU) group will continue to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group will receive a 2-hour individual appointment in clinic with a doctoral level clinician with extensive experience in behavioral treatments for encopresis. During the appointment, the clinician will review strategies to increase continence by providing parent education on the following topics: how to collect and evaluate data on their child's bowel movements, how to establish and use a sit schedule, identifying behaviors that are precursors to bowel movements and how to use them to increase the probability of a bowel movement being continent, consequences for incontinence, and reinforcement for continence.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females from 5 years of age to 12 years 11 months of age.
• Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Autism Spectrum Disorder as established by clinical assessment, corroborated by the Autism Diagnostic Observational Schedule, Autism Diagnostic Interview-Revised and/or Childhood Autism Rating Scale-Second Edition.
• Fewer than 60% of days are continent days or more than 1 day out of 7 is an incontinent day over the previous 7 days (a continent day is defined as a day with at least one continent bowel movement. An incontinent day is a day with an incontinent bowel movement regardless of whether a continent bowel movement also occurs).
• Medication free or on stable medication (no changes in past 6 weeks and no planned changes for the next 6 months).
• Urine continent - Over half of the voids are continent when the child is with the parent and when the child is on a typical toileting routine.

You may not qualify if:

• Presence of a current serious behavioral problem or psychiatric condition that would require another treatment (e.g., psychotic disorder, major depression, moderate or greater aggression, severe disruptive behavior), based on information collected at screening and the Behavior Problems Inventory-01 (BPI-01).
• Currently receiving and caregiver refusal to discontinue ongoing behavioral or alternative medical intervention for encopresis.

Sponsors & Collaborators

• Emory University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Encopresis; Autism Spectrum Disorder; Constipation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Results Point of Contact

• Title: Nathan Call, PhD
• Organization: Emory University

ncall@emory.edu

404-785-9428

Study Officials

• Nathan Call, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures, including the Parent-nominated Target Problem (PTP), will be conducted by separate independent evaluators (IE) each of who are blind to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 56 participants will be assigned to 2 weeks of the Multidisciplinary Intervention for Encopresis (MIE) treatment, 56 will be assigned to treatment as usual (TAU) as a control group. Twenty-six participants were assigned to the study arm with one week of MIE, which has been discontinued.

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 23, 2017
• Study Start: October 25, 2017
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)