The investigators will plan a multi-site Phase III clinical trial of a sensory-based rehabilitation for children who suffer traumatic birth injuries. Collaborators are renowned occupational therapists from three universities and three direct service programs, with decades of experience. They are assisted by three expert consultants and three Research Advisory Councils, constituted of national experts who reside near each local team. The Research Advisory Councils will meet with the regional teams to assist with planning and will meet with the national team once when the team meets at their site. Twenty percent of children with traumatic birth injuries are treated for major disorders, and another 20% have no sequelae of birth trauma. This planning grant focuses on the remaining 60% who suffer hidden handicaps, e.g. subtle limitations and disabilities, not usually identified until the children fail school. One such hidden handicap is Sensory Modulation Dysfunction, a disability manifested by severe difficulties regulating responses to sensory input, that occurs in the absence of any frank peripheral or central nervous system damage. Children with SMD have such extreme over-responsivity to sensation that the child and family's daily life routines are substantially disrupted. The investigators will plan a Phase III masked randomized prospective clinical trial across three diverse geographic regions (CO, CA, MA). The complex process of planning Phase III clinical trials is problematic in OT, because a well-established clinical research infrastructure does not exist. This grant will provide a mechanism for the first time in the history of OT to carefully plan a multisite study to evaluate the effectiveness of this form of pediatric rehabilitation. Hypotheses for a Phase III Clinical Trial: The investigators hypothesize that children with significant birth trauma, who receive a specific type of sensory- based OT rehabilitation intervention will have (a) positive psychophysiological changes (e.g., electrodermal activity and vagal tone); (b) improved impulse control (attention) and emotion regulation; improved self- care, coping, and social participation at home and at school; and (d) better sustainability of family routines due to decreased parental stress.
Aims for one-year Planning Grant: The investigators will plan and write an R01, to submit at the end of the planning period. They will convene four one- week meetings quarterly, have bi-monthly conference calls, and complete individual tasks. This will permit (1) the definition of specific inclusion/exclusion criteria, (2) the selection of outcome measures across NCMRR levels of disablement, (3) characterization of the exact intervention protocol, (4) specification of a method to measure fidelity to the treatment model, and (5) specification of data analysis and interpretation methods.
