Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges

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.

Study Overview

• Status: Completed
• Conditions: Sensory Processing Disorder
• Intervention / Treatment: Other: Sensory Integration Intervention through the STAR Frame of Reference

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Norfolk, Massachusetts, United States, 02056
      • H. Olive Day School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeated Dependent Variable Measurement	Repeated dependent variable measurement will be based on weekly video recorded samples of functional regulation and active participation behaviors in the classroom rated by a trained observer. Each student participant will be videotaped while in the general education classroom for 10 minutes once per week.	5-7 weeks of Baseline and 15 weeks of intervention for a total of up to 22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Assessment System for Children-3 (BASC-3)	The Behavior Assessment System for Children -3, as a teacher rating scale, is a tool that measures the student's adaptive and problem behaviors in the school setting. Scores will not be compared but general clinical categories that can be rated as normal, at risk or clinically significant.	During first week of baseline and again within a week of completion of 15 weeks of intervention
Short Child Occupational Profile (SCOPE)	The Short Child Occupational Profile is a 25-item word-based occupation-focused assessment that measures components based on the Model of Human Occupation (MOHO) and was designed to provide a broad overview of a child's occupational participation. Total scores will be between 0 and 57. A higher score will be better, indicating better function.	During first week of baseline and again within a week of completion of 15 weeks of intervention
Goal Attainment Scaling (GAS)	A therapist who is using the Goal Attainment Scaling method with a student needs to both accurately predict the level of performance at the end of an identified period of time and decide upon what performance will look like in scaled intervals above and below the expected level of goal attainment. The teacher and occupational therapist then will develop the goal attainment follow-up guide in which expected level of achievement for each goal is scaled as zero, and achievement above and below is scaled from -2 to +2, to measure progress following intervention. 0 is expected performance and +2 is much more than expected.	During first week of baseline and again within a week of completion of 15 weeks of intervention
Semi-structured interview with teacher	Each participant's main classroom teachers will be interviewed in a semi-structured format to determine gains in perceived competency for supporting the students with sensory processing challenges following the last session of intervention.	Within a week of completing 15 weeks of intervention
Semi-structured interview with student	Each student participant will have the opportunity to comment on his or her lived experience in a semi-structured interview following the last session of the intervention.	Within a week of completing 15 weeks of intervention

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Investigators: Study Chair: Karen Jacobs, Boston University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 14, 2021
• Primary Completion (ACTUAL): February 7, 2022
• Study Completion (ACTUAL): February 7, 2022

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 5722E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No