Purpose

The multiple baseline single subject design study with replication across three participants in a public-school setting. The 15-week independent variable will be a direct service occupational therapy intervention, combined with teacher consultations, based on the STAR (Sensory Therapies and Research) Frame of Reference. Frequently measured dependent variables, as the main determinants of change resulting from the intervention, will be student's video-recorded performance in the areas of functional regulation and active participation in the classroom, as rated by a trained observer. Findings of the single subject study will be corroborated via semi-structured interviews with the student participants and their teachers, administration of systematic assessments and Goal Attainment Scaling.

Condition

Eligibility

Eligible Ages
Between 3 Years and 8 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Student has a) suspected sensory processing challenges and b) difficulty with functional regulation and active participation in the classroom. 2. not remediated by Tier 2 intervention 3. Evaluation finds: 1. total score, or 3 or more scales, for the main classroom on the Sensory Processing Measure are more than one standard deviation, namely is in the some problems or definite difference range, 2. clinical determination that the student demonstrates disrupted sensory processing issues that are impacting his or her ability to participate in the school setting, and 3. student requires specialized intervention in the form of direct pull-out service delivery in order to access his or her education.

Exclusion Criteria

  1. The student has an autism diagnosis or a primary genetic, orthopedic, or neurological disorder. 2. The student is participating in occupational therapy outside of school.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Multiple baseline design across participants
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
STAR intervention
Each research participant will receive individual 30-minute therapy sessions two times per week for fifteen weeks. Fifteen weekly ten-minute consultations with the teacher will also be conducted for each participant.
  • Other: Sensory Integration Intervention through the STAR Frame of Reference
    The individualized therapy program will be based on the results of the comprehensive evaluation. Intervention aligns with the STAR Frame of Reference fidelity measure and Ayres Fidelity Measure.

More Details

Status
Enrolling by invitation
Sponsor
Boston University Charles River Campus

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.