Clinical trial NCT04769674: Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges
Official title: Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensory Processing Disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 3
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple baseline design across participants
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Repeated Dependent Variable Measurement
timeFrame: 5-7 weeks of Baseline and 15 weeks of intervention for a total of up to 22 weeks
Secondary outcomes:
measure: Behavior Assessment System for Children-3 (BASC-3)
timeFrame: During first week of baseline and again within a week of completion of 15 weeks of intervention
measure: Short Child Occupational Profile (SCOPE)
timeFrame: During first week of baseline and again within a week of completion of 15 weeks of intervention
measure: Goal Attainment Scaling (GAS)
timeFrame: During first week of baseline and again within a week of completion of 15 weeks of intervention
measure: Semi-structured interview with teacher
timeFrame: Within a week of completing 15 weeks of intervention
measure: Semi-structured interview with student
timeFrame: Within a week of completing 15 weeks of intervention
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: H. Olive Day School
state: Massachusetts
Study officials:
affiliation: Boston University
name: Karen Jacobs
role: STUDY_CHAIR
References: