Trial Outcomes & Findings for Treatment of Encopresis in Children With Autism Spectrum Disorders (NCT NCT03197922)

NCT ID: NCT03197922

Last Updated: 2024-01-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

117 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2024-01-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks Participants in this arm received 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 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.	Treatment as Usual (TAU) Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Overall Study STARTED	26	47	44
Overall Study COMPLETED	18	32	40
Overall Study NOT COMPLETED	8	15	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Encopresis in Children With Autism Spectrum Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.	Total n=117 Participants Total of all reporting groups
Age, Continuous	6.87 years STANDARD_DEVIATION 1.61 • n=5 Participants	7.38 years STANDARD_DEVIATION 1.94 • n=7 Participants	7.26 years STANDARD_DEVIATION 1.69 • n=5 Participants	7.12 years STANDARD_DEVIATION 1.76 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	36 Participants n=7 Participants	36 Participants n=5 Participants	91 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	36 Participants n=7 Participants	37 Participants n=5 Participants	99 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants	43 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	27 Participants n=7 Participants	18 Participants n=5 Participants	58 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized More than one race or other race	1 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment United States	26 Participants n=5 Participants	47 Participants n=7 Participants	44 Participants n=5 Participants	117 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: This analysis includes participants with complete data from parent reports of bowel movements during the prior week.

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.

Outcome measures

Outcome measures
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=37 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=40 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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 Baseline	27.33 percentage of bowel movements Standard Deviation 29.72	16.99 percentage of bowel movements Standard Deviation 28.48	20.70 percentage of bowel movements Standard Deviation 25.80
Percentage of Continent Bowel Movements Week 8	55.50 percentage of bowel movements Standard Deviation 33.18	79.69 percentage of bowel movements Standard Deviation 29.51	37.74 percentage of bowel movements Standard Deviation 35.92

SECONDARY outcome

Timeframe: Week 8

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.

Outcome measures

Outcome measures
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score No response (CGI-I score of 3 to 7)	16 Participants	26 Participants	37 Participants
Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score Response (CGI-I score of 1 or 2)	10 Participants	21 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: This analysis includes parents of children who were participating in the study at the indicated study visit. Twenty-seven participants withdrew or were lost to follow-up prior to the Week 8 assessment.

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.

Outcome measures

Outcome measures
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Parenting Stress Index Short Form Total Score Baseline	82.38 score on a scale Standard Deviation 23.25	81.72 score on a scale Standard Deviation 24.79	91.22 score on a scale Standard Deviation 20.94
Parenting Stress Index Short Form Total Score Week 8	80.88 score on a scale Standard Deviation 23.95	82.76 score on a scale Standard Deviation 29.68	89.19 score on a scale Standard Deviation 24.45

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score Baseline Objective Strain Subscale Score	9.68 score on a scale Standard Deviation 4.35	9.86 score on a scale Standard Deviation 4.51	9.40 score on a scale Standard Deviation 3.91
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score Week 8 Objective Strain Subscale Score	9.53 score on a scale Standard Deviation 3.41	8.21 score on a scale Standard Deviation 4.20	9.29 score on a scale Standard Deviation 4.04

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score Baseline Subjective Internalized Strain Subscale Score	8.88 score on a scale Standard Deviation 3.26	10.16 score on a scale Standard Deviation 3.89	9.29 score on a scale Standard Deviation 3.06
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score Week 8 Subjective Internalized Strain Subscale Score	9.06 score on a scale Standard Deviation 3.13	7.24 score on a scale Standard Deviation 3.51	9.58 score on a scale Standard Deviation 3.58

SECONDARY outcome

Timeframe: Baseline, Week 8

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.

Outcome measures

Outcome measures
Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 Participants Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 Participants Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 Participants Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score Baseline	18.56 score on a scale Standard Deviation 7.12	20.03 score on a scale Standard Deviation 7.58	18.69 score on a scale Standard Deviation 6.46
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score Week 8	18.59 score on a scale Standard Deviation 6.15	15.45 score on a scale Standard Deviation 7.30	18.87 score on a scale Standard Deviation 7.05

Adverse Events

Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Treatment as Usual (TAU)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Nathan Call, PhD

Emory University

Phone: 404-785-9428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week n=26 participants at risk Participants in this arm received 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 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. This study arm was discontinued in October 2019.	Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks n=47 participants at risk Participants in this arm received 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 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.	Treatment as Usual (TAU) n=44 participants at risk Participants randomized to the Treatment as Usual (TAU) group continued to receive outpatient medical treatment of encopresis according to best practice guidelines by the pediatric gastroenterologist. In addition, participants in the TAU group received 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 reviewed 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.
Injury, poisoning and procedural complications Abrasion on chin	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Injury, poisoning and procedural complications Bump on back of head	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Cavity	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Injury, poisoning and procedural complications Cut on ear from haircut	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Problem behavior	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Mid-sleep awakening	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	4.3% 2/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	4.5% 2/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Inappropriate language	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Difficulty waking up	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	4.5% 2/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Infections and infestations Strep throat	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Infections and infestations Infected toe nail	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Naps during the day	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Skin and subcutaneous tissue disorders Red itchy rash on leg	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Ear and labyrinth disorders Ear bleed	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Nervous system disorders Seizures	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Ear and labyrinth disorders Ear infection	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Infections and infestations Rhinitis	19.2% 5/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	8.5% 4/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	9.1% 4/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Sore throat	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Respiratory, thoracic and mediastinal disorders Coughing	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Gastrointestinal disorders Vomiting	11.5% 3/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Gastrointestinal disorders Diarrhea	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	6.4% 3/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	6.8% 3/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Gastrointestinal disorders Constipation	11.5% 3/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	29.8% 14/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	18.2% 8/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Metabolism and nutrition disorders Excessive appetite	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Renal and urinary disorders Enuresis	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Tired during the day	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Difficulty falling asleep	11.5% 3/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	11.4% 5/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Early morning waking	11.5% 3/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Interrupted sleep	0.00% 0/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Infections and infestations Fever	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	4.5% 2/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Immune system disorders Allergies	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	4.3% 2/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Infections and infestations Swollen tonsils	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Respiratory, thoracic and mediastinal disorders Runny nose	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.3% 1/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
Skin and subcutaneous tissue disorders Eczema	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	0.00% 0/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	6.8% 3/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.
General disorders Difficulty staying asleep	3.8% 1/26 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	2.1% 1/47 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.	4.5% 2/44 • Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8.