Barriers to recruitment of children with cerebral palsy in a trial of home-based training.

Many trials fail to include the targeted number of participants, causing scientific and ethical problems. The COAD trial of home-based training programs (HBTPs) for children with unilateral cerebral palsy (CP) encountered recruitment problems, even though the parent-delivered home-based approach complies with recent health-care developments in the Netherlands. The current project aimed to identify the barriers to recruitment in the COAD trial. This summative, multidimensional evaluation comprised informal conversational interviews in which stakeholders who had been involved reflected on the factors that impeded successful recruitment of participants into the COAD trial. Barriers to implementation and recruitment were clustered according to the constructs of the Consolidated Framework for Implementation Research (CFIR). Member checking validated the findings. A total of 41 stakeholders contributed to the evaluation. Barriers to the implementation of the HBTPs were identified within every domain of the CFIR (intervention characteristics, outer setting, inner setting, characteristics of individuals, and process). Parent-delivered home-based training was perceived as highly complex and in conflict with the pressures on and the needs of parents. Many parents preferred the alternative center-based group interventions. The involvement of a resonance group was highly valued, and opportunities for further enhancements emerged. Additionally, the importance of research consortia was emphasized. The appropriateness of the RCT as the study design was criticized. The findings of this study are summarized in a tool which provides a dozen directions for the successful recruitment of participants in pediatric rehabilitation research.

Development of the Drooling Infants and Preschoolers Scale (DRIPS) and reference charts for monitoring saliva control in children aged 0-4 years.

OBJECTIVES: To develop and validate a parent questionnaire to quantify drooling severity and frequency in young children (the Drooling Infants and Preschoolers Scale - the DRIPS). To investigate development of saliva control in typically developing young children in the age of 0-4 years. To construct sex-specific reference charts presenting percentile curves for drooling plotted for age to monitor the development of saliva control in infancy and preschool age. STUDY DESIGN: The DRIPS was developed consisting of 20 items to identify severity and frequency of drooling during meaningful daily activities. Factor analysis was performed to test construct validity. A piecewise logistic regression was followed by a piecewise linear regression to construct sex-specific reference charts. RESULTS: We obtained 652 completed questionnaires from parents of typically developing children. The factor analysis revealed four discriminating components: drooling during Activities, Feeding, Non nutritive sucking, and Sleep. To illustrate the development of saliva control, eight sex-specific reference curves were constructed to plot the scores of the DRIPS by age group, at the 15th, 50th, 85th and 97th percentile. About 3-15% of the preschoolers in our cohort did not acquire full saliva control at the age of 4 years. CONCLUSIONS: With the DRIPS it is possible to validly compare and visualize the development of saliva control in an individual infant or preschooler and allow clinicians to timely initiate individually targeted interventions if children outperform.

Self-management treatment of drooling: a case series.

Behavioral treatment of drooling is advocated widely, but evidence of its effectiveness is lacking. In a center-based case-series study, 10 participants with severe drooling were taught self-management skills to reduce drooling. Following treatment, all participants remained dry for intervals of 30-60 min, while being engaged in daily activities. Generalization to the classroom occurred in each participant. For three participants, maintenance of treatment effect was established at 6 and 24 weeks. Seven participants failed to maintain self-management skills at follow-up. Although the self-management procedure showed promising results, further adaptations are required to improve efficacy, generalization, and maintenance.