20129
Pilot Randomized Clinical Trial of a Wireless Moisture Pager for Toileting Training Children with Autism Spectrum Disorder
For many children with ASD, toileting acquisition is delayed, resulting in decreased independence; therefore, a training method that is user-friendly and effective is needed. We developed a a novel enuresis alarm (the wireless moisture pager [WMP]) and a corresponding manualized intervention The WMP consists of an Ipod-based app that interfaces with a transmitter/disposable sensor positioned in the child's underwear. The WMP emits an auditory page upon contact with urine and provides Bluetooth data transmission for timely clinician monitoring and feedback.
Objectives:
The primary objective of this study was to evaluate the feasibility of the study protocol (i.e., ≥80% of recruitment and retention targets; ≥80% fidelity of parent training by interventionists and ≥80% fidelity of parent implementation). The secondary objective was to examine trends in outcome data by conducting a small RCT (N =30) of WMP and a standard behavioral intervention (SBT). Specific outcome measures included: (1) rate of urine accidents and toilet usage following 3 months intervention and at 3 month follow-up, (2) rate of toileting skill acquisition, and (3) parent satisfaction with intervention.
Methods:
Thirty-three participants, ages 3-6 with an ASD diagnosis and inability to use the toilet, were randomized 1:1 to either the WMP or SBT group. For both groups, parents received training at baseline and were expected to carry out their assigned interventions for 12 weeks with “booster sessions” at weeks 2, 4, 6, 9, and 12. Initial training sessions were recorded and scored using a fidelity checklist by an independent rater. Parents recorded data regarding accidents and toileting for 3 consecutive days prior to each booster session and 3 months after intervention. Interventionists rated parent fidelity to intervention at each visit. Parent satisfaction questionnaires were collected at final study visit.
Results:
Participant recruitment targets were successfully met and retention rates were not significantly below target (69% for WMP; 88% for SBT). Initial trainings were administered with a high degree of fidelity (95% for WMP; 97% for SBT). Parents implemented interventions with a high degree of fidelity (mean fidelity scores of 88-90% at each visit for WMP; 92-97% for SBT). At the conclusion of 12 weeks of intervention, no statistically significant differences were found for: (1) rate of at least 2+ daily urine accidents (WMP = 67%; SBT = 85%; p=0.38) and (2) median 3-day count of urination successes (WMP = 3.5; SBT = 2.0; p=0.72). No statistically significant differences on these measures were found at 3 months post-intervention. Using Kaplan-Meier curves indicates no significant group differences in time to toileting acquisition. Parent satisfaction with intervention was similar between the two groups.
Conclusions:
This study provides evidence that well-controlled research comparing parent implemented toilet training methods in the home setting can be conducted. Though outcomes were not statistically significant, differences in the trend of urination accidents over time between the WMP and SBT groups provide some indication that the wireless moisture pager intervention is promising. Future comparative studies with a greater number of participants are warranted.