FINAL REPORT for Multi-Site Planning Grant
January 2002 to December 2003

Outcome of Sensory-Based Intervention after Birth Trauma
R21 Planning Grant RFA (1R21HD/AR41614-01)
National Institute of Child Health and Human Development/National Center
for Medical Rehabilitation Research
September 2001-August 2002

Introduction

We proposed planning a multi-site controlled clinical trial of a sensory-based rehabilitation for children who are suffering from sensory processing disorders. Eleven collaborators, who are renowned occupational therapists from four universities and three direct service programs, were selected to participate:
  • Academic Centers
  • : University of Colorado Health Sciences Center, Denver: Lucy Jane Miller, Ph.D., OTR and Barbara Brett-Green, Ph.D.; University of Southern California, Los Angeles: Diane Parham, Ph.D., OTR; Boston University, Boston: Ellen Cohn, Sc.D., OTR; Thomas Jefferson University, Philadelphia: Roseann Schaff, Ph.D., OTR and Janice Burke, Ph.D., OTR.

  • Clinical Centers: The Children’s Hospital of Denver, Occupational Therapy Dept.: Clare Summers, M.A., OTR; Occupational Therapy Associates—Watertown, near Boston: Jane Koomar, Ph.D., OTR and Teresa May-Benson, OTR; Pediatric Therapy Network, near Los Angeles: Zoe Mailloux, M.A., OTR and Susanne Smith Roley, M.A., OTR.

We proposed to focus our planning activities on methods of identification and intervention across sites for children who manifest Sensory Processing Disorders (SPD), 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 SPD have such abnormal responses to sensation that the child and family’s daily life routines are substantially disrupted.

Background and Need for this Multi-site Planning Grant

Throughout the history of occupational therapy, the profession has included individuals who have been both clinical and scholarly with a strong tradition and commitment to writing about the significance of clinical ideas to our overall understanding of occupation and its relevance to health and function. The efforts of the American Occupational Therapy Foundation (AOTF) during the 1980’s are an example of strategic, research-oriented efforts within the profession to develop a critical mass of researchers who could be initially funded and groomed to eventually compete for federal research dollars. All of these efforts followed a traditional model that focused on developing the individual researcher with specific research projects that fit comfortably into the climate of research and health care practice of the time.

In spite of the efforts, occupational therapy has not launched a comprehensive research trajectory that provides substantial evidence about the effectiveness of its interventions. Allied health professions generally continue to place their priorities and resources into supporting the training and strategies necessary to advance clinical practice. While the profession of occupational therapy has built a substantial group of scholars and researchers, most of them hold administrative and faculty positions. Thus, research focused on a programmatic line of inquiry is not common in our field. Needless to say, the quality and depth of research in specific lines of inquiry related to occupational therapy are profoundly impacted by the lack of allocation of human resources and the availability of funding streams to support the research efforts in the profession.

However, occupational therapy, like all clinically focused professions, is under scrutiny to supply cost effective services, justifying its procedures based on evidence. Occupational therapists are on a historical precipice in which health care acknowledges the value of what occupational therapists focus on (e.g., functional abilities and social participation). We now must rise to the standards of professions that nurture research and advance our professional standards of excellence in the research arena.

The research in SPD provides an excellent example of the historical and current state of research in occupational therapy. Acting alone, A. Jean Ayres devoted her career (1950-1988) to sensory integration theory, research and practice, producing volumes of applied and clinically relevant research. In order to develop and test her theories and clinical strategies, Ayres designed and implemented a strategic program of clinically relevant research, modeling a standard of research equivalent to that found in the fields of psychology and neuroscience that had not been previously experienced within occupational therapy. None of this work was federally funded.

Through a systematic line of inquiry, Ayres prioritized the creation of objective, reliable and valid assessments of the constructs identified in her theories of sensory integration. These studies prepared the way for the research that could discriminate populations with SPD best served by occupational therapy (OT) strategies, and set the stage for outcome studies that demonstrate significant change as a result of intervention.

Ayres’ mentorship resulted in a significant number of OT researcher/scholars/master clinicians all trained in the same frame of reference. Through Ayres’ work and that of her colleagues, SPD has become the most widely researched area in the field of occupational therapy. Nevertheless, despite the tradition of this frame of reference steeped in research, occupational therapy with children who have SPD has a dearth of rigorous research demonstrating treatment effectiveness.

Miller (2003) addressed these concerns in her recent article reviewing empirical evidence related to therapies for SPD. Acknowledging the need for further research related to the effectiveness of intervention for sensory processing disorders, she points out that occupational therapy for children with SPD is "unproven, not ineffective." She proposes several salient key points related to the state of research focusing on sensory processing:
  1. Lack of attempts to define a homogeneous sample
  2. Lack of a published intervention protocol or a replicable method of establishing fidelity to treatment
  3. Lack of sensitive and meaningful outcomes connected to specific intervention
  4. Methodological limitations (e.g., power, randomization, blinding, control groups)

In order to address these ongoing concerns, this R21 grant was formally obtained to initiate the process of planning a multi-site intensive nationwide collaboration among experts in SPD and occupational therapy from both academic and clinical settings. Informally, the project also provided an opportunity for participants to support and encourage one another as they met to discuss the obstacles they faced in making progress toward establishing sound methods and obtaining funding for OT effectiveness research. Specifically, the collaborative meetings provided an opportunity to develop a strategic plan for systematically moving towards applying for one or more nationally funded randomized clinical trials to examine the effectiveness of occupational therapy with children who have SPD.

A strategic plan was formulated by the collaborators. Key features of the strategic plan included:
  • Identification of priorities: Identifying the existing body of research related to measuring the effectiveness of occupational therapy for children with SPD
  • Focusing efforts: Gaining professional commitments from each collaborator to the overall goals of the project along the lines of individual interest and assisting the overall goals of the collaboration
  • Pooling resources: Sharing financial, academic, knowledge, university and clinic supports, data, and educational opportunities
  • Sharing ideas: Using a think tank approach to carefully consider the essential elements that would be needed to make the strategic plan to accomplish a randomized controlled trial a reality
  • Networking with people from key funding agencies: Inviting outside consultants who provided specific expertise on funding agencies’ priorities and fundraising
  • Consultation on physiological measures: Meeting with individuals who provided expertise on advanced technical equipment design and technical support
  • Collaborative focus: Implementing the grant with the combined efforts of researchers, scholars, and master clinicians

The R21 planning group met eight times during the two-year grant period (one year no cost extension). The results of this R21 grant include:

Table 1. Results of the R21 Planning Grant

Goal

Result

Address the homogeneity of the sample.

Collect physiological data on typical subjects and clinical populations

We established five identical psychophysiological laboratories that use consistent protocols for data collection and analysis

Create systems for sharing data and increasing sample size

We created a data bank using the same system allowing individual sites to collect and seamlessly share like information

Establish a standard for replicable intervention methods

We created a measure to assure fidelity to treatment across sites and established reliability and validity of the fidelity measure

Decide upon meaningful and sensitive outcomes addressing the concerns of the client

We developed a protocol for Goal Attainment Scaling as an outcome measure and agreed upon several other outcomes that would be used cross-site, a combination of standardized tests and physiologic data

Build the body of knowledge and research related to occupational therapy effectiveness research

We are currently documenting the collaborative efforts through publications in refereed journals within and outside of occupational therapy (four collaborative papers in progress)

Assist researchers in developing and sustaining a programmatic line of inquiry

We accomplished grant submissions to federal agencies (submission of 2 R01s, 2 to NIDRR, 1 to OSERS, several K01 awards planned; multiple private foundations; and several intra-institutional grants)

Increase individual capability to apply competitively and conduct research

We have mentored members of our collaborative team to increase their individual areas of expertise, particularly the domains of applying for funding and psychophysiologic research

This collaborative process, initiated by the NIH planning grant, reframes the research process for this domain of OT, and moves from an individual based model such as that used by Ayres’ to an organized strategy with an agenda and blueprint for a collaborative program of research related to the effectiveness of occupational therapy with children who have SPD.

CONCLUSION

The profession of occupational therapy is entering a historical stage of its evolution where evidence is essential to validate the procedures and outcomes produced through occupational therapy. If we are to move forward, the profession must create a research culture that values and supports the contribution of research teams composed of individuals who are fully dedicated to planning and implementing programmatic research. By using the R21, we have developed a new collaborative research model that capitalizes on the strengths of each member of the group to achieve a common goal.

Future Implications for Research in Occupational Therapy

With an increasingly sophisticated pool of researchers, clinicians and scholars, occupational therapy has the potential to conduct research that can make a significant contribution to the field of rehabilitation. We have utilized a collaborative research planning model to provide a vehicle for propelling researchers into viable funding streams. Without a coordinated collaborative approach, individual researchers are limited. All rehabilitation professions are experiencing the same scrutiny and imperative to provide proof for their actions. If occupational therapy continues the current course, we will undoubtedly fall behind other professions competing for research dollars. Occupational therapy cannot become stagnant with minimal internal and external research support. The productiveness and outcomes of this R21 collaborative sensory processing research group is a first step in realizing the promise and far reaching impact of networking and collaboration on demonstrating the outcomes of occupational therapy. Our current team members have submitted five federal, seven foundations, and two intra-mural grants since obtaining the R21. We plan to continue submitting for funding until we receive the necessary funds to conduct multiple single—site studies and eventually a multi-site study evaluating the effectiveness of occupational therapy in ameliorating SPD. We have plans to continue to meet and collaborate three times a year using internally obtained funding.

Reference

Miller, L.J. (2003). Empirical evidence related to therapies for sensory processing impairments. National Association of School Psychologists Communique, 31, #5, February 2003.

Table 2. Meetings and Accomplishments During the Two-Year Planning Grant

Denver

Los Angeles

Philadelphia

Boston

AOTA

1995-2001:

Original site of research program

February 2001:

Annual PTN research conference provides forum for networking between researchers and clinicians

2000-2001:

Research vagal tone methodology to share across sites

June 2001:

Research conference provides forum for networking between researchers and clinicians

May 2001:

Annual think tank meeting at AOTA to plan agenda for the year and assign responsibilities

2002:

Develop data base to share across sites

February 2002:

Annual think tank meeting inviting consultants to discuss future research
   

May 2002:

Annual think tank meeting at AOTA to solidly each team members’ plans

April 2003:

Physiological laboratory provides research mentorship experience for other basic scientists on grant

July 2003: Physiological laboratories at PTN and USC provides research mentorship experience for clinicians and students

January 2003: Physiological laboratory provides research mentorship experience for students

August 2003: Physiological laboratory provides research mentorship experience for clinicians

May 2003:

Annual think tank meeting to share progress and continue to develop responsibilities

2002-2003:

Grant submissions to 2 federal, 8 foundations and two intra-institutional sources

2003:

Grant submission to 1 federal

2002-2003:

Grant submissions to 3 federal, 2 foundations, 1 intra-institutional source

2003:

Grant submissions to intra-institutional and 1 to private foundation
 

January 2003:

Pilot fidelity measure with selected therapists

July 2002:

Staff at PTN involved in review of literature for fidelity measure

July 2002 (cont’d.): Selected clinical staff participates in pilot study on fidelity measure, inter-rater reliability and validity studies
 

March 2003:

Selected staff involved in review and revision of fidelity measure

March 2003 (cont’d.):

Student involvement in preliminary fidelity development
 
 

July 2003:

European Sensory Integration course instructors review fidelity measure
     
 

August 2003:

Concepts of fidelity adapted to education in sensory integration through USC/WPS
     

Presentations
  • AOTA, 2003; Developing a Fidelity to Treatment Measure for Outcome Studies in OT
  • AOTA, 2004; Outcomes from a Pilot Randomized Controlled Trial: Evidence of the Effectiveness of OT with Children who have Sensory Processing Disorders
  • MCH Conference, 2003; Sensory Integration: Examining the Evidence
  • R2K, Pediatric Therapy Network Research Conference: Neuroplasticity and Occupational Therapy: Evidence from a Pilot Randomized Controlled Trial

Publications in Progress
  • Revisiting and Revising a Strategic Plan for Research in a Clinical Profession: A Consensus Statement from an R21 Planning Grant
  • Use of Goal Attainment Scaling in Outcomes Research
  • Development of a Fidelity to Treatment Protocol for Measuring Occupational Therapy Outcomes with Children who have Sensory Processing Disorders
  • Physiological Outcomes of Occupational Therapy with Children who have Sensory Processing Disorders

Summary of Future Plans
  • Ongoing meetings triennially
  • Continued collaboration on grant submissions
  • Publication of current and future research findings
  • Adapt information to education in Sensory Processing Disorders
  • Fundraising to achieve these goals


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