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Completed

NCT Number: NCT04769674

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.

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Key information

Conditions

Sensory Processing Disorder

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Olive Day School

Norfolk, Massachusetts, 02056, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Repeated Dependent Variable Measurement

    Time frame: 5-7 weeks of Baseline and 15 weeks of intervention for a total of up to 22 weeks

    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.

Secondary outcomes

  1. Behavior Assessment System for Children-3 (BASC-3)

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

    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.

  2. Short Child Occupational Profile (SCOPE)

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

    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.

  3. Goal Attainment Scaling (GAS)

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

    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.

  4. Semi-structured interview with teacher

    Time frame: Within a week of completing 15 weeks of intervention

    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.

  5. Semi-structured interview with student

    Time frame: Within a week of completing 15 weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2021
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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