Encopresis, Autistic Disorder
Conditions
Keywords
Behavioral Symptoms, Child Development Disorders, Pervasive, Bowel Incontinence, Constipation
Brief summary
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.
Detailed description
A large percentage of individuals with autism spectrum disorder (ASD) are delayed in achieving continence with bowel movements or never achieve it at all (i.e., they meet criteria for encopresis). This problem has tremendous ramifications for these individuals and their families because encopresis restricts them from integration with peers, limits access to educational opportunities, and carries significant social stigma. Previous interventions for encopresis in this population have either been unsuccessful or required implementation over very long periods.
Interventions
Nursing staff will administer one glycerin suppository in the bathroom if there is no continent bowl movement in the first 30 minutes. Subjects will be taken to the bathroom 5 minutes after the suppository is administered for a 30 minute sit or until a continent void occurs. If continent bowel movements maintain on two subsequent days (after bisacodyl suppositories are discontinued) the glycerin suppository will be discontinued. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
If a subject does not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they will be given a 1 hour break, after which a bisacodyl suppository will be administered. The participant will then sit for an additional 30 minutes.If continent bowel movements maintain for two subsequent days (after senna is discontinued) bisacodyl suppositories will be discontinued if it was required. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
DRUGSenna
If no continent bowel movements occur for two consecutive treatment days, caregivers will be asked to administer senna each evening thereafter until medication tapering begins. Once there have been two successive days with continent bowel movements, senna will be removed from the intervention if it was required.
Sponsors
Organization for Autism Research
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Continent | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | The percentage of participant's with continent bowel movements (control of passage of stool from the bowel). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Independence | Baseline, Post-Intervention (Week 2) , Follow Up (Week 4) | 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. |
| Mean Clinical Global Impression for Severity (CGI-S) Score | Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10) | 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 |
| Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 6), Post-Intervention (Week 10) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between February 2015 and January 2017.
Pre-assignment details
Of the 22 subjects consented for participation, 20 were randomized to a study intervention and were included in study analyses.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Program Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program immediately.
Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.
Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.
Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began. | 10 |
| Waitlist Control Pediatric subjects with autistic spectrum disorder were randomized to participate in the encopresis treatment program 8 weeks after providing consent.
Glycerin Suppository: Nursing staff administered one glycerin suppository in the bathroom if there was no continent bowl movement in the first 30 minutes.
Bisacodyl suppository: If a subject did not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they were given a 1 hour break, after which a bisacodyl suppository was administered.
Senna: If no continent bowel movements occurred for two consecutive treatment days, caregivers were asked to administer senna each evening thereafter until medication tapering began. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | Treatment Program |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 16 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Percent Continent
The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).
Time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Program | Percent Continent | Post-Intervention (Week 2) | 6 percentage of participants |
| Treatment Program | Percent Continent | Baseline | 0 percentage of participants |
| Treatment Program | Percent Continent | Follow Up (Week 4) | 5 percentage of participants |
| Waitlist Control | Percent Continent | Baseline | 0 percentage of participants |
| Waitlist Control | Percent Continent | Post-Intervention (Week 2) | 0 percentage of participants |
| Waitlist Control | Percent Continent | Follow Up (Week 4) | 0 percentage of participants |
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.
Time frame: Post-Intervention (Week 6), Post-Intervention (Week 10)
Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Program | Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 6) | 3.0 units on a scale | Standard Deviation 0.5 |
| Treatment Program | Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 10) | 2.1 units on a scale | Standard Deviation 0.9 |
| Waitlist Control | Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 6) | 3.8 units on a scale | Standard Deviation 0.6 |
| Waitlist Control | Mean Clinical Global Impression for Improvement (CGI-I) Score | Post-Intervention (Week 10) | 3.6 units on a scale | Standard Deviation 1 |
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
Time frame: Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)
Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Program | Mean Clinical Global Impression for Severity (CGI-S) Score | Post-Intervention (Week 6) | 5.0 units on a scale | Standard Deviation 0.9 |
| Treatment Program | Mean Clinical Global Impression for Severity (CGI-S) Score | Baseline | 5.4 units on a scale | Standard Deviation 0.7 |
| Treatment Program | Mean Clinical Global Impression for Severity (CGI-S) Score | Post-Intervention (Week 10) | 4.3 units on a scale | Standard Deviation 0.9 |
| Waitlist Control | Mean Clinical Global Impression for Severity (CGI-S) Score | Baseline | 5.2 units on a scale | Standard Deviation 0.4 |
| Waitlist Control | Mean Clinical Global Impression for Severity (CGI-S) Score | Post-Intervention (Week 6) | 5.0 units on a scale | Standard Deviation 0.5 |
| Waitlist Control | Mean Clinical Global Impression for Severity (CGI-S) Score | Post-Intervention (Week 10) | 4.9 units on a scale | Standard Deviation 0.6 |
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.
Time frame: Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)
Population: An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Program | Percent Independence | Baseline | 0 percentage of participants |
| Treatment Program | Percent Independence | Post-Intervention (Week 2) | 0 percentage of participants |
| Treatment Program | Percent Independence | Follow Up (week 4) | 5 percentage of participants |
| Waitlist Control | Percent Independence | Baseline | 0 percentage of participants |
| Waitlist Control | Percent Independence | Post-Intervention (Week 2) | 0 percentage of participants |
| Waitlist Control | Percent Independence | Follow Up (week 4) | 0 percentage of participants |