Adults 5 to 12, any sex, with Encopresis or Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Continent Bowel MovementsPrimary· 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.
Baseline
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
27.33
± 29.72
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
16.99
± 28.48
Treatment as Usual (TAU)
20.70
± 25.80
Week 8
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
55.50
± 33.18
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
79.69
± 29.51
Treatment as Usual (TAU)
37.74
± 35.92
Number of Children Responding to Treatment as Rated by the Clinical Global Impression Scale - Improvement (CGI-I) ScoreSecondary· 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 res
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
16
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
26
Treatment as Usual (TAU)
37
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
10
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
21
Treatment as Usual (TAU)
7
Parenting Stress Index Short Form Total ScoreSecondary· 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.
Baseline
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
82.38
± 23.25
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
81.72
± 24.79
Treatment as Usual (TAU)
91.22
± 20.94
Week 8
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
80.88
± 23.95
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
82.76
± 29.68
Treatment as Usual (TAU)
89.19
± 24.45
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Objective Strain Subscale ScoreSecondary· 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.
Baseline Objective Strain Subscale Score
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
9.68
± 4.35
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
9.86
± 4.51
Treatment as Usual (TAU)
9.40
± 3.91
Week 8 Objective Strain Subscale Score
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
9.53
± 3.41
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
8.21
± 4.20
Treatment as Usual (TAU)
9.29
± 4.04
Caregiver Strain Questionnaire - Short Form 7 (CGSQ-SF7) Subjective Internalized Strain Subscale ScoreSecondary· 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.
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
9.06
± 3.13
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
7.24
± 3.51
Treatment as Usual (TAU)
9.58
± 3.58
Caregiver Strain Questionnaire - Short Form (CGSQ-SF7) Total ScoreSecondary· 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.
Baseline
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
18.56
± 7.12
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
20.03
± 7.58
Treatment as Usual (TAU)
18.69
± 6.46
Week 8
Group
Value
95% CI
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
18.59
± 6.15
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
15.45
± 7.30
Treatment as Usual (TAU)
18.87
± 7.05
Adverse events — posted to ClinicalTrials.gov
Time frame: Information on adverse events was collected from the time of the baseline visit through the follow-up assessment at Week 8..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Multidisciplinary Intervention for Encopresis (MIE) Treatment for One Week
Serious: 0/26 (0%)
Deaths: 0/26
Multidisciplinary Intervention for Encopresis (MIE) Treatment for Two Weeks
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 31 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03197922.