Trial · NCT03197922
Treatment of Encopresis in Children With Autism Spectrum Disorders
NCT03197922, Phase 3, Completed, Emory University; results first posted 2024-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Encopresis in Children With Autism Spectrum Disorders. Trials, record NCT03197922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03197922
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Encopresis in Children With Autism Spectrum Disorders
- NCT number
- NCT03197922
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Encopresis, Autism Spectrum Disorder
- Interventions
- MIE Treatment, Glycerin Suppository, Treatment as Usual (TAU)
- First posted
- 2017-06-23
- Last updated
- 2024-01-31
- Results first posted
- 2024-01-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Continent Bowel Movements | Baseline, Week 8 | 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. |
| Secondary | Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score | 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. |
| Secondary | Parenting Stress Index Short Form Total Score | Baseline, Week 8 | 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. |
| Secondary | Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score | 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. |
| Secondary | Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score | 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. |
| Secondary | Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Continent Bowel Movements | Baseline, Week 8 | This analysis includes participants with complete data from parent reports of bowel movements during the prior week. | percentage of bowel movements | MEAN |
| SECONDARY | Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score | Week 8 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Parenting Stress Index Short Form Total Score | Baseline, Week 8 | 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. | score on a scale | MEAN |
| SECONDARY | Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale Score | Baseline, Week 8 | 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. | score on a scale | MEAN |
| SECONDARY | Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale Score | Baseline, Week 8 | 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. | score on a scale | MEAN |
| SECONDARY | Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total Score | Baseline, Week 8 | 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. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Continent Bowel Movements | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Baseline | 27.33 | Standard Deviation 29.72 | percentage of bowel movements |
| Percentage of Continent Bowel Movements | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Baseline | 16.99 | Standard Deviation 28.48 | percentage of bowel movements |
| Percentage of Continent Bowel Movements | Treatment as Usual (TAU) | Baseline | 20.70 | Standard Deviation 25.80 | percentage of bowel movements |
| Percentage of Continent Bowel Movements | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Week 8 | 55.50 | Standard Deviation 33.18 | percentage of bowel movements |
| Percentage of Continent Bowel Movements | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | Week 8 | 79.69 | Standard Deviation 29.51 | percentage of bowel movements |
| Percentage of Continent Bowel Movements | Treatment as Usual (TAU) | Week 8 | 37.74 | Standard Deviation 35.92 | percentage of bowel movements |
| Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | No response (CGI-I score of 3 to 7) | 16 | Participants | |
| Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | No response (CGI-I score of 3 to 7) | 26 | Participants | |
| Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score | Treatment as Usual (TAU) | No response (CGI-I score of 3 to 7) | 37 | Participants | |
| Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) Score | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | Response (CGI-I score of 1 or 2) | 10 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 26 | |
| Overall Study | STARTED | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 47 | |
| Overall Study | STARTED | Treatment as Usual (TAU) | 44 | |
| Overall Study | COMPLETED | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 18 | |
| Overall Study | COMPLETED | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 32 | |
| Overall Study | COMPLETED | Treatment as Usual (TAU) | 40 | |
| Overall Study | NOT COMPLETED | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 8 | |
| Overall Study | NOT COMPLETED | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 15 | |
| Overall Study | NOT COMPLETED | Treatment as Usual (TAU) | 4 |
Source ClinicalTrials.gov
Adverse events105
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Seizures | Nervous system disorders | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 0 | 26 | |
| other | Seizures | Nervous system disorders | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 1 | 47 | |
| other | Seizures | Nervous system disorders | Treatment as Usual (TAU) | 0 | 44 | |
| other | Ear infection | Ear and labyrinth disorders | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 0 | 26 | |
| other | Ear infection | Ear and labyrinth disorders | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 0 | 47 | |
| other | Ear infection | Ear and labyrinth disorders | Treatment as Usual (TAU) | 1 | 44 | |
| other | Rhinitis | Infections and infestations | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 5 | 26 | |
| other | Rhinitis | Infections and infestations | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 4 | 47 | |
| other | Rhinitis | Infections and infestations | Treatment as Usual (TAU) | 4 | 44 | |
| other | Sore throat | General disorders | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 1 | 26 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 0 | 26 |
| Total, all-cause mortality | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 0 | 47 |
| Total, all-cause mortality | Treatment as Usual (TAU) | 0 | 44 |
| Total, other adverse events | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 24 | 26 |
| Total, other adverse events | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 35 | 47 |
| Total, other adverse events | Treatment as Usual (TAU) | 41 | 44 |
| Total, serious adverse events | Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week | 0 | 26 |
| Total, serious adverse events | Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks | 0 | 47 |
| Total, serious adverse events | Treatment as Usual (TAU) | 0 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03197922
GET https://conductscience.org/api/trials/v1/NCT03197922/results?page=2