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

NCT ID: NCT04769674

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2022-02-07

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.

Conditions

Sensory Processing Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensory Integration Intervention through the STAR Frame of Reference

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Colleen Cameron Whiting

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Jacobs

Role: STUDY_CHAIR

Boston University

Locations

H. Olive Day School

Norfolk, Massachusetts, United States

Countries

United States

Other Identifiers

5722E

Identifier Type: -

Identifier Source: org_study_id