Comprehensive Toileting Programming: Enuresis Treatment to a Randomized Clinical Trial of a Caregiver-Mediated Multidisciplinary Intervention for Encopresis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical Global Impression Improvement (CGI-I) scale score
研究概览
简要总结
The current study aims to monitor fecal continence after autistic youth complete enuresis treatment and for individuals who continue to experience encopresis after acquiring urine continence, evaluate a caregiver-mediated version of a Multidisciplinary Intervention for Encopresis (CM-MIE) delivered via telehealth to determine efficacy in a randomized clinical trial.
详细描述
Participants will complete toilet training for enuresis (if needed) and then monitored to determine if encopresis persists. For individuals with resolved enuresis but persisting encopresis, they will be randomized to receive either a treatment for encopresis (delivered via telehealth) or a parent education program. The encopresis intervention involves behavioral components and administration of an over-the-counter suppository as needed. All participants will also meet with a pediatric gastroenterologist to ensure safety of study procedures and to resolve constipation as needed. Outcomes will include caregiver-completed questionnaires, data on bowel movements collected by the caregiver, and an interview between the participant's caregiver and a blinded investigator focused on encopresis, other presenting concerns, and any potential adverse events.
Informed consent will be collected via signature from one legal guardian. The investigators will collect assent from participants when appropriate given age and developmental level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded independent evaluator will conduct the Clinical Global Impression scale.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 to 12
- •Diagnosis of an intellectual or developmental delay (excluding individuals with ADHD alone)
- •Encopresis (more than 1 incontinent BM a week)
- •Required for pre-randomization phase only: Enuresis (> 1 incontinent urination per day when on a consistent toileting sit schedule)
- •At least one caregiver who speaks and understands English
排除标准
- •Unresolved medical condition that would impede toilet training (e.g., interference with sphincter control, short gut syndrome, urinary tract or gastrointestinal infection, unexplained diarrhea, recent intestinal surgery, inflammatory bowel disease)
- •Failed intensive toileting treatment in the past 2 yrs with protocols akin to study
- •Current serious behavioral or psychiatric disorder that requires another treatment
- •Current or planned other intervention (behavioral or medical) for incontinence
研究组 & 干预措施
Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm
- A Board-Certified Behavior Analyst (BCBA) will meet virtually with caregivers for daily appointments for two weeks (goal of 10 appointments; maximum of 2-hours per appointment).
- First appointment, the BCBA will provide support on using telehealth and psychoeducation about encopresis, reinforcement, and suppository use.
- Subsequent appointments involve a scheduled sit on the toilet to encourage an independent bowel movement. If a bowel movement occurs, the caregiver is coached to provide the child with a highly preferred item, praise, and allow them to leave the bathroom. If a bowel movement does not occur, the therapist coaches the parent through administration of a glycerin suppository intended to quickly elicit a bowel movement, followed by another scheduled sit on the toilet.
- After consistent success with continent BMs following suppository administration, the suppository dose will be reduced to gradually fade out its use.
干预措施: Behavioral strategies (Behavioral)
Parent Education (PE) Arm
- PE includes an initial appointment with a BCBA who will provide recommendations on promoting bowel movement continence.
- First appointment will involve a didactic review of the basics of reinforcement, collecting data to identify when BMs are most likely, and scheduled sits around this time. Caregivers will be instructed to collect data on BMs after this appointment.
- The BCBA will then hold daily follow-up appointments (10 appointments total over 2 weeks). At these appointments, the BCBA will review this data and make additional recommendations (e.g., changing the timing of scheduled sits based on when BMs are most likely to occur, altering the reinforcer used for continent voids) to promote success.
干预措施: Behavioral strategies (Behavioral)
Caregiver-mediated version of multidisciplinary intervention for encopresis (CM-MIE) Arm
- A Board-Certified Behavior Analyst (BCBA) will meet virtually with caregivers for daily appointments for two weeks (goal of 10 appointments; maximum of 2-hours per appointment).
- First appointment, the BCBA will provide support on using telehealth and psychoeducation about encopresis, reinforcement, and suppository use.
- Subsequent appointments involve a scheduled sit on the toilet to encourage an independent bowel movement. If a bowel movement occurs, the caregiver is coached to provide the child with a highly preferred item, praise, and allow them to leave the bathroom. If a bowel movement does not occur, the therapist coaches the parent through administration of a glycerin suppository intended to quickly elicit a bowel movement, followed by another scheduled sit on the toilet.
- After consistent success with continent BMs following suppository administration, the suppository dose will be reduced to gradually fade out its use.
干预措施: Glycerin Suppository (Drug)
结局指标
主要结局
Clinical Global Impression Improvement (CGI-I) scale score
时间窗: 5 weeks post-baseline (Endpoint)
The CGI-I is a clinician-rated 7-point scale measuring overall change from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse), rated by the treatment-blind independent evaluator (IE) with all available information. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) will define positive response; all other ratings are defined as nonresponders. Number of positive responses for the Clinical Global Impression scale will be compared between the CM-MIE and the PE group.
次要结局
- Caregiver Strain Questionnaire-short form (CGSQ-SF) score(5 weeks post-baseline (Endpoint))
- Fecal continence based on caregiver-collected data(5 weeks post-baseline (Endpoint))
研究者
Mindy Scheithauer
Associate Professor
Emory University