Autistic Disorder Clinical Trial
Official title:
An Interdisciplinary Approach to the Treatment of Encopresis in Children With Autism Spectrum Disorders
Verified date | May 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to try to treat bowel movement (BM) accidents differently with children with autism spectrum disorder (ASD). The study will use over-the-counter (OTC) medications to evoke predictable bowel movements. This will make it possible for investigators to use certain strategies to reward BMs in the toilet. Independence will be increased by fading out the use of medications. The investigators will also train caregivers to implement the procedures.
Status | Completed |
Enrollment | 22 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 21 Years |
Eligibility |
Inclusion Criteria: - Age 5-21 - Confirmed diagnosis of autistic spectrum disorder using the Social Communication Questionnaire (SCQ) and the Childhood Autism Rating Scale II (CARSII) - Clearance from gastroenterologist for use of glycerin suppository, bisacodyl suppository and senna - Caregiver willing to give consent/assent Exclusion Criteria: - Age under 5 year or over 21 years - Does not present a diagnosis of autistic spectrum disorder - Previous intestinal surgeries or concurrent enuresis - Caregiver unwilling to give consent/assent |
Country | Name | City | State |
---|---|---|---|
United States | Marcus Autism Center | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Organization for Autism Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Continent | The percentage of participant's with continent bowel movements (control of passage of stool from the bowel). | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | |
Secondary | Percent Independence | Percent independence is the percentage of independent bowel movements recorded by a caregiver. A continent bowel movement without the use of any medications will constitute an independent bowel movement. | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | |
Secondary | Mean Clinical Global Impression for Severity (CGI-S) Score | An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients | Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10) | |
Secondary | Mean Clinical Global Impression for Improvement (CGI-I) Score | An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Improvement (CGI-I). Clinical Global Impression for Improvement (CGI-I) Scale is a clinician's assessment of a patient's change in condition from baseline.The score ranges from 0 = not assessed, 1 = very much improved, through 7 = very much worse. | Post-Intervention (Week 6), Post-Intervention (Week 10) |
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