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Encopresis & MIE (DoD #2)

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ClinicalTrials.gov Identifier: NCT03197922
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Nathan A. Call, Ph.D., BCBA-D, Emory University

Brief Summary:

This study is comparing 2-week and 1-week versions of 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 one of the treatment groups start attending daily appointments in clinic for either 1 week or 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 150 children diagnosed with ASD, randomizing them to 2 weeks of MIE , 1 week 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.


Condition or disease Intervention/treatment Phase
Encopresis Autism Spectrum Disorder Combination Product: MIE Treatment Phase 3

Detailed Description:

Toilet training one's child is a nearly universal challenge for parents, but is a particularly distressing ordeal for parents of individuals with autism spectrum disorder (ASD). Whereas typically developing children generally stop having daytime toileting accidents (i.e., they achieve continence) by 2-4 years of age, most individuals with ASD are either delayed in their acquisition of toileting skills, or never achieve continence. Furthermore, toileting concerns are a significant contributor to the increased stress experienced by caregivers of those with ASD. Besides dramatically increasing their burden of care, not being fully toilet trained negatively impacts the individual with ASD's hygiene, self-confidence, physical comfort, and independence while also causing social stigma. Incontinence can also have serious collateral consequences, such as limiting exposure to important life experiences. Furthermore, without effective treatment these problems generally persist into adulthood.

One reason why strictly behavioral treatments of encopresis have shown only limited success may be due to the fact that it often has a medical etiology. Encopresis is when underwear are soiled by stool in children over the age of toilet training and long-standing constipation is the cause of encopresis in the majority of children who exhibit it. Children with ASD are more likely to have constipation than typically developing children. Constipation causes encopresis by creating a cycle of withholding bowel movements (withholding is the voluntary contraction of the external sphincter to avoid a bowel movement): constipation causes painful bowel movements, which triggers further withholding behavior, exacerbating constipation. Over time the colon adapts by dilating, which leads to larger fecal masses in the rectum. Thus, the passage of larger and harder (i.e., painful) stools further increases an individual's withholding behavior. Over time, the rectum and colon become so dilated that the individual loses sensation. With no urge to defecate, an individual is even more likely to have stool accumulate in the rectum and is also unable to control bowel movements. Looser stool may leak around hard stool leading to an unintended leakage and sometimes large evacuation of stool occurs without the individual realizing it.

Although purely medical approaches can successfully treat constipation in individuals with ASD, they have not shown long term success with encopresis. That is, medical approaches can treat a single episode of constipation, but without acquiring toileting skills, the individual is likely to become constipated again, repeating the cycle. Conversely, purely behavioral strategies have not been shown to be effective at treating encopresis in individuals with ASD, even when they are not experiencing constipation. One reason for this lack of success may have to do with the fact that it is often difficult to predict the timing of a bowel movement so that caregivers can ensure the individual is sitting on the toilet when one takes place and then reinforce continence. Thus, a multidisciplinary approach incorporating both medical and behavioral approaches is necessary in the treatment of encopresis in individuals with ASD.

This is an 8-week, randomized clinical trial of 150 children, ages 5 to 12 years, 11 months with ASD and encopresis. Subjects will be randomized in a 2:2:1 ratio to receive either one week of MIE, two weeks of MIE or one week of TAU.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 60 participants will be assigned to 2 weeks of the Multidisciplinary Intervention for Encopresis (MIE) treatment, 60 will be assigned to 1 week of treatment with MIE, and 30 will be assigned to treatment as usual (TAU) as a control group.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Multidisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MIE Treatment for Two Weeks
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.
Combination Product: MIE Treatment
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 30 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement. If no continent bowel movement occurs, 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.
Other Name: Multidisciplinary Intervention for Encopresis

Experimental: MIE Treatment for One Week
Participants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for one week. 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.
Combination Product: MIE Treatment
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 30 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement. If no continent bowel movement occurs, 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.
Other Name: Multidisciplinary Intervention for Encopresis

No Intervention: Treatment as Usual (TAU)
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.



Primary Outcome Measures :
  1. Change in Continence [ Time Frame: Baseline, Week 8 ]
    A Chi-square test will be used to compare the proportion of children who achieve continence (70% of days are continent days and no more than 1 incontinent day over a 7-14 day period) based on parent report at Week 8 (endpoint of acute randomized trial). The contrasts will be MIE-1 vs TAU and MIE-2 vs TAU.


Secondary Outcome Measures :
  1. Clinical Global Impression Scale - Improvement (CGI-I) Score [ Time Frame: Week 8 ]
    A Chi-square test will be used to compare the proportion of children who are rated by the Independent Evaluator as Much Improved of Very Much Improved on the CGI-I at Week 8. The contrasts will be MIE-1 vs TAU and MIE-2 vs TAU.

  2. Caregiver Strain Questionnaire [ Time Frame: Baseline, Week 8 ]
    ANCOVA will be used to compare change in parental stress and strain from baseline to Week 8 as measured on the Parenting Stress Index and the Caregiver Strain Questionnaire. The contrasts will be MIE-1 vs TAU and MIE-2 vs TAU.


Other Outcome Measures:
  1. Change in Continence between MIE-1 vs MIE-2 [ Time Frame: Week 8, Week 28 ]
    A Chi-square test will be used to compare the proportion of children who achieve continence at Week 8 (endpoint of acute randomized trial) and Week 28 (last follow up visit). The contrasts will be MIE-1 vs MIE-2.

  2. Change in Independence between MIE-1 vs. MIE-2 [ Time Frame: Week 8, Week 28 ]
    A Chi-square test will be used to compare the proportion of children who achieve independence (continent bowel movements without the need for a suppository) at Weeks 8 and 28. The contrasts will be MIE-1 vs MIE-2.

  3. Clinical Global Impression Scale - Improvement (CGI-I) Score between MIE-1 vs. MIE-2 [ Time Frame: Week 8, Week 28 ]
    A Chi-square test will be used to compare the proportion of children who are rated by the Independent Evaluator as Much Improved of Very Much Improved on the CGI-I at Weeks 8 and 28. The contrasts will be MIE-1 vs MIE-2.

  4. Caregiver Strain Questionnaire MIE-1 vs. MIE-2 [ Time Frame: Baseline, Week 8, Week 28 ]
    ANCOVA will be used to compare change in parental stress from baseline to Week 8 and baseline to Week 28. The contrasts will be MIE-1 vs MIE-2.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females > 5 years of age and ≤ 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.
  • Less than 60% of days are continent days or more than 1 day out of 7 is an incontinent day over the past two weeks (Continent day is defined as a day with at least one continent bowel movement and no incontinence. 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 - one or fewer episodes of incontinent urination each day

Exclusion Criteria:

  • Presence of a known medical condition in the child (based on medical history or physical examination) that would interfere with child's ability to control his/her anus. These include: History of any anal surgery, spinal dysraphism (e.g., spina bifida), other neurologic disorder affecting anal function, and prolonged/recurrent gastrointestinal infectious disease (e.g. Clostridium difficile colitis). In addition, the following may constitute exclusions following evaluation by a physician: Inflammatory bowel disease, short gut syndrome, chronic diarrhea, or history of intestinal/abdominal surgery.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197922


Contacts
Contact: Nathan Call, PhD 404-785-9428 ncall@emory.edu

Locations
United States, Georgia
Marcus Autism Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Nathan Call, PhD    404-785-9428    ncall@emory.edu   
Principal Investigator: Nathan Call, PhD         
Sponsors and Collaborators
Emory University
United States Department of Defense
Investigators
Principal Investigator: Nathan Call, PhD Emory University

Responsible Party: Nathan A. Call, Ph.D., BCBA-D, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03197922     History of Changes
Other Study ID Numbers: IRB00095849
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Nathan A. Call, Ph.D., BCBA-D, Emory University:
Autism Spectrum Disorder
Constipation

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Encopresis
Fecal Incontinence
Neurodevelopmental Disorders
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases