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Behavioural Intervention

MIE Treatment for Two Weeks for Autism Spectrum Disorder

Phase 3
Waitlist Available
Led By Nathan Call, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8, week 28
Awards & highlights

Study Summary

This trial is testing a new intervention for encopresis (poop accidents) in children with autism spectrum disorder. The intervention is a combination of medical and behavioral treatment, and the researchers are testing it against usual care. The goal is to see if the new intervention is more effective than usual care and to determine how long the intervention should last.

Eligible Conditions
  • Autism Spectrum Disorder
  • Encopresis
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8, week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Continent Bowel Movements
Secondary outcome measures
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score
+2 more
Other outcome measures
Caregiver Strain Questionnaire MIE-1 vs. MIE-2
Change in Continence between MIE-1 vs MIE-2
Change in Independence between MIE-1 vs. MIE-2
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MIE Treatment for Two WeeksExperimental Treatment2 Interventions
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.
Group II: MIE Treatment for One WeekExperimental Treatment2 Interventions
Participants in this arm will receive the Multidisciplinary Intervention for Encopresis (MIE) for one week. This study arm was discontinued in October 2019.
Group III: Treatment as Usual (TAU)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glycerin Suppository
2015
Completed Phase 4
~1670
MIE Treatment
2017
Completed Phase 3
~120

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,456 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
21,548 Patients Enrolled for Autism Spectrum Disorder
United States Department of DefenseFED
861 Previous Clinical Trials
227,077 Total Patients Enrolled
18 Trials studying Autism Spectrum Disorder
1,623 Patients Enrolled for Autism Spectrum Disorder
Nathan Call, PhDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
348 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
348 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any dangers associated with MIE Treatment for Two Weeks?

"MIE Treatment for Two Weeks received a score of 3, meaning that while it is still in Phase 3 trials, there is evidence to support both its efficacy and safety from multiple rounds of testing."

Answered by AI

Are elderly individuals being sought after for this particular research project?

"Children that are between 5 to 12 years old may participate in this study."

Answered by AI

Are there any open appointments for this experimental procedure?

"No, this study is not recruiting at the moment. Although the last update to the posting on clinicaltrials.gov was on September 22nd, 2022, the original post date was October 25th, 2017. There are other 311 studies which are presently enrolling patients."

Answered by AI

What are researchers aiming to discover through this clinical trial?

"The aim of this study, as measured over an 8-week period starting from baseline, is to increase the number of children that achieve continence. Additionally, the investigators will secondary outcomes including caregiver strain and stress levels before and after treatment. The study also intends to measure changes in clinical global impression and parenting stress index scores."

Answered by AI

How can I become a part of this research?

"This trial is enrolling 138 children between the ages of 5 and 12 who have autism spectrum disorders. The following criteria must also be met: Males and females from 5 years of age to 12 years 11 months of age., 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"

Answered by AI
~16 spots leftby Apr 2025