Sensory Processing Disorder Clinical Trial
Official title:
Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges
NCT number | NCT04769674 |
Other study ID # | 5722E |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 14, 2021 |
Est. completion date | February 7, 2022 |
Verified date | February 2022 |
Source | Boston University Charles River Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | February 7, 2022 |
Est. primary completion date | February 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 8 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | H. Olive Day School | Norfolk | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04167839 -
Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement
|
N/A | |
Completed |
NCT04994613 -
Use of an Adaptive Sensory Environment in Autism Spectrum Disorder (ASD) Patients in the Perioperative Environment
|
N/A | |
Not yet recruiting |
NCT06079632 -
Telehealth Parent Coaching to Improve Activity Participation for Young Children With ASD and SPD
|
N/A | |
Completed |
NCT00766051 -
A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.
|
N/A | |
Recruiting |
NCT06234033 -
Neural Mechanisms of Sensory Processing Anomalies
|
||
Recruiting |
NCT06333925 -
Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study
|
N/A | |
Not yet recruiting |
NCT06361407 -
Sensory and Cognitive Predictions, and Their Disruptions in Schizophrenia
|
N/A | |
Recruiting |
NCT06324721 -
Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling
|
N/A | |
Enrolling by invitation |
NCT05249270 -
Online Parent-Report Evaluation of the Effects of Processed Music
|
||
Completed |
NCT06216379 -
Sensory Processing Associated With Motor Skills
|
||
Recruiting |
NCT06411808 -
Evaluating Sensory-Adapted Dental Care in Children With Sensory Processing Disorders
|
N/A | |
Recruiting |
NCT05967962 -
Sensory Modulation Dysfunction and Posttraumatic Stress Disorder
|
N/A | |
Recruiting |
NCT06247176 -
Sensory Habituation in Autism Spectrum Disorders
|
N/A | |
Recruiting |
NCT05811559 -
Investigation of Sensory Processing Patterns of Elderly Individuals Who Have Had Hip Fracture Surgery
|
||
Completed |
NCT05217199 -
The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2
|
||
Recruiting |
NCT04173871 -
Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®
|
N/A | |
Completed |
NCT04713839 -
Adult Sensory Processing Scale (ASPS) Version of Turkish
|