Sensory Processing DisorderNCT04769674
Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges
A study testing Sensory Integration Intervention through the STAR Frame of Reference in people with Sensory Processing Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Sensory Processing Disorder
- What is being tested?
- Sensory Integration Intervention through the STAR Frame of Reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- The student has an autism diagnosis or a primary genetic, orthopedic, or neurological disorder.
- The student is participating in occupational therapy outside of school.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Sensory Integration Intervention through the STAR Frame of Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration Intervention through the STAR Frame of ReferenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sensory Integration Intervention through the STAR Frame of Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within a week of completing 15 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start14 May 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Processing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple baseline design across participants
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Cameron Whiting, Boston University Charles River Campus
- Investigators
- Karen Jacobs, Study chair, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769674
- Sponsor's protocol ID
- 5722E
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of STAR (Sensory Therapies and Research) Intervention for School-Based Occupational Therapy Services for Students With Sensory Processing Challenges
- ClinicalTrials.gov ID
- NCT04769674
- Acronym / sponsor ID
- 5722E
- Conditions
- Sensory Processing Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline design across participants
| Arm | Type | Receives |
|---|---|---|
| STAR intervention | Experimental | Other: Sensory Integration Intervention through the STAR Frame of ReferenceEach 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (2 listed)
- The student has an autism diagnosis or a primary genetic, orthopedic, or neurological disorder.
- The student is participating in occupational therapy outside of school.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Integration Intervention through the STAR Frame of ReferenceThe 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. | Other | STAR intervention |
Primary outcome
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.
5 secondary outcomes
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
Short Child Occupational Profile (SCOPE)
Time frame: During first week of baseline and again within a week of completion of 15 weeks of intervention
Goal Attainment Scaling (GAS)
Time frame: During first week of baseline and again within a week of completion of 15 weeks of intervention
Semi-structured interview with teacher
Time frame: Within a week of completing 15 weeks of intervention
Semi-structured interview with student
Time frame: Within a week of completing 15 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Jacobs study chair
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Intervention through the STAR Frame of Reference in people with Sensory Processing Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated Dependent Variable Measurement (time frame: 5-7 weeks of Baseline and 15 weeks of intervention for a total of up to 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.