A Phase 3 interventional study of MIE Treatment and Glycerin Suppository in Encopresis and Autism Spectrum Disorder, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Emory University · Phase 3, Interventional, and Treatment
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.
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 112 children, ages 5 to 12 years, 11 months with ASD and encopresis. Participants will be randomized to receive either two weeks of MIE or one week of TAU. The study initially had a third study arm of one week of MIE treatment, which was discontinued in October of 2019.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 117 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
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
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
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.
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.
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.
Time frame: Baseline, Week 8
Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score
The Clinical Global Impression Scale - Improvement (CGI-I) is a single item asking clinicians to indicate the degree of improvement following treatment on a 7-point scale. Responses are 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. This study is interested in the proportion of children who are rated by the Independent Evaluator as "Much Improved" or "Very Much Improved" on the CGI-I at Week 8. Responding to treatment is defined as a score of 1 or 2, while scores of 3 to 7 are considered as not responding to treatment. Response to treatment is analyzed through imputation, consistent with an intent to treat approach, where participants who withdrew from the study or were lost to follow-up prior to the Week 8 assessment are considered to be non-responders.
Time frame: Week 8
Parenting Stress Index Short Form Total Score
The Parenting Stress Index Short Form (PSI-SF) is a 36-item questionnaire assessing parental stress. It has three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Each subscale has 12 items where responses are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Scores for subscales range from 12 to 60 and the total score ranges from 36 to 180. Higher scores indicate greater parental stress.
Time frame: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. The total score for the Objective Strain subscale ranges from 0 to 16 and higher scores indicate greater parental strain.
Time frame: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. The total score for the Subjective Internalized Strain subscale ranges from 0 to 12 and higher scores indicate greater parental strain.
Time frame: Baseline, Week 8
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. A total score is obtained by adding the scores for each subscale. Total scores range from 0 to 28 where higher scores indicate greater caregiver strain.
Time frame: Baseline, Week 8
Participants were recruited from the Marcus Autism Center in Atlanta Georgia. Participant enrollment began October 25, 2017 and all study follow-up was complete by November 17, 2022.
| Milestone | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| Started | 26 | 47 | 44 |
| Completed | 18 | 32 | 40 |
| Not completed | 8 | 15 | 4 |
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.
| percentage of bowel movements | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| Baseline | 27.33 ± 29.72 | 16.99 ± 28.48 | 20.70 ± 25.80 |
| Week 8 | 55.50 ± 33.18 | 79.69 ± 29.51 | 37.74 ± 35.92 |
The Clinical Global Impression Scale - Improvement (CGI-I) is a single item asking clinicians to indicate the degree of improvement following treatment on a 7-point scale. Responses are 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. This study is interested in the proportion of children who are rated by the Independent Evaluator as "Much Improved" or "Very Much Improved" on the CGI-I at Week 8. Responding to treatment is defined as a score of 1 or 2, while scores of 3 to 7 are considered as not responding to treatment. Response to treatment is analyzed through imputation, consistent with an intent to treat approach, where participants who withdrew from the study or were lost to follow-up prior to the Week 8 assessment are considered to be non-responders.
| Participants | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| No response (CGI-I score of 3 to 7) | 16 | 26 | 37 |
| Response (CGI-I score of 1 or 2) | 10 | 21 | 7 |
The Parenting Stress Index Short Form (PSI-SF) is a 36-item questionnaire assessing parental stress. It has three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Each subscale has 12 items where responses are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Scores for subscales range from 12 to 60 and the total score ranges from 36 to 180. Higher scores indicate greater parental stress.
| score on a scale | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| Baseline | 82.38 ± 23.25 | 81.72 ± 24.79 | 91.22 ± 20.94 |
| Week 8 | 80.88 ± 23.95 | 82.76 ± 29.68 | 89.19 ± 24.45 |
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. The total score for the Objective Strain subscale ranges from 0 to 16 and higher scores indicate greater parental strain.
| score on a scale | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| Baseline Objective Strain Subscale Score | 9.68 ± 4.35 | 9.86 ± 4.51 | 9.40 ± 3.91 |
| Week 8 Objective Strain Subscale Score | 9.53 ± 3.41 | 8.21 ± 4.20 | 9.29 ± 4.04 |
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. The total score for the Subjective Internalized Strain subscale ranges from 0 to 12 and higher scores indicate greater parental strain.
| score on a scale | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| Baseline Subjective Internalized Strain Subscale Score | 8.88 ± 3.26 | 10.16 ± 3.89 | 9.29 ± 3.06 |
| Week 8 Subjective Internalized Strain Subscale Score | 9.06 ± 3.13 | 7.24 ± 3.51 | 9.58 ± 3.58 |
The Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) assesses parental stress and strain in the prior month in caregivers who are caring for a child with behavioral disorders. The CGSQ-SF includes 7 items where responses are given on a 5-point scale where "not at all" is scored as 0 and "very much" is scored as 4. The CGSQ-SF7 has two subscales: Objective Strain with four items, and Subjective Internalized Strain with three items. A total score is obtained by adding the scores for each subscale. Total scores range from 0 to 28 where higher scores indicate greater caregiver strain.
| score on a scale | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| Baseline | 18.56 ± 7.12 | 20.03 ± 7.58 | 18.69 ± 6.46 |
| Week 8 | 18.59 ± 6.15 | 15.45 ± 7.30 | 18.87 ± 7.05 |
Collected over Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 0/26 (0%) | 0/26 (0%) | 24/26 (92.3%) |
| Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 0/47 (0%) | 0/47 (0%) | 35/47 (74.5%) |
| Treatment as Usual (TAU) | 0/44 (0%) | 0/44 (0%) | 41/44 (93.2%) |
| Event | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 3/26 | 14/47 | 8/44 |
| RhinitisInfections and infestations | 5/26 | 4/47 | 4/44 |
| VomitingGastrointestinal disorders | 3/26 | 1/47 | 1/44 |
| Difficulty falling asleepGeneral disorders | 3/26 | 1/47 | 5/44 |
| Early morning wakingGeneral disorders | 3/26 | 0/47 | 0/44 |
| DiarrheaGastrointestinal disorders | 0/26 | 3/47 | 3/44 |
| EczemaSkin and subcutaneous tissue disorders | 1/26 | 0/47 | 3/44 |
| FeverInfections and infestations | 1/26 | 0/47 | 2/44 |
| Difficulty staying asleepGeneral disorders | 1/26 | 1/47 | 2/44 |
| Mid-sleep awakeningGeneral disorders | 0/26 | 2/47 | 2/44 |
| Age, Continuous(years) | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| Mean | 6.87 ± 1.61 | 7.38 ± 1.94 | 7.26 ± 1.69 | 7.12 ± 1.76 |
| Sex: Female, Male(Participants) | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| Female | 7 | 11 | 8 | 26 |
| Male | 19 | 36 | 36 | 91 |
| Ethnicity (NIH/OMB)(Participants) | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 7 | 4 | 11 |
| Not Hispanic or Latino | 26 | 36 | 37 | 99 |
| Unknown or Not Reported | 0 | 4 | 3 | 7 |
| Race/Ethnicity, Customized(Participants) | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| White | 11 | 10 | 22 | 43 |
| Black or African American | 13 | 27 | 18 | 58 |
| Asian | 1 | 2 | 1 | 4 |
| More than one race or other race | 1 | 8 | 3 | 12 |
| Region of Enrollment(Participants) | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| United States | 26 | 47 | 44 | 117 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University