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

NCT04769674 | Completed

• 1 other identifier: 5722E
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Behavior Assessment System for Children-3 (BASC-3)

  During first week of baseline and again within a week of completion of 15 weeks of intervention

• Short Child Occupational Profile (SCOPE)

  During first week of baseline and again within a week of completion of 15 weeks of intervention

• Goal Attainment Scaling (GAS)

  During first week of baseline and again within a week of completion of 15 weeks of intervention

• Semi-structured interview with teacher

  Within a week of completing 15 weeks of intervention

• Semi-structured interview with student

  Within a week of completing 15 weeks of intervention

Study Arms (1)

STAR intervention

EXPERIMENTAL

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

Interventions

Sensory Integration Intervention through the STAR Frame of Reference 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.

STAR intervention

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Student has a) suspected sensory processing challenges and b) difficulty with functional regulation and active participation in the classroom.
• not remediated by Tier 2 intervention
• Evaluation finds:
• 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,
• clinical determination that the student demonstrates disrupted sensory processing issues that are impacting his or her ability to participate in the school setting, and
• student requires specialized intervention in the form of direct pull-out service delivery in order to access his or her education.

You may not qualify if:

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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

H. Olive Day School

Norfolk, Massachusetts, 02056, United States

Location

Study Officials

• Karen Jacobs

  Boston University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Multiple baseline design across participants

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: May 14, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)