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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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Preterm infants are at risk for feeding problems which can persist through early childhood. These feeding problems may include oral motor, sensory, digestive, nutritional, respiratory, and/or behavioral components. In North Carolina's early intervention program, speech pathologists or occupational therapists are responsible for completing feeding evaluations, and may not know when to refer infants out to medical specialists to address these other domains. This study will test a decision support tool in hypothetical feeding evaluation scenarios. The hypothetical scenarios will consist of real feeding videos of preterm infants who recently participated in a multidisciplinary feeding evaluation. Parent-reported outcomes of the infant's real evaluation will be compared to those of the speech pathologists and occupational therapists in our study who do, and do not, use the decision support tool. The investigators hypothesize that therapists with the tool will make recommendations that are closer to those of the multidisciplinary team, and that they will find the tool useful and easy to use.
Due to recruitment limitations with families, the study was adapted in October, 2021 prior to enrollment of subjects to use case studies, rather than infant videos, as the hypothetical situation from which to test the tool. Therapists will then answer clinical questions without using the tool when viewing the first case study, and will use the tool to answer questions when viewing the second case study. Order of case study presentation will be randomized among participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case A then Case B | Experimental | Participant will first review and answer questions about Case A without using the tool. Then, they will use the tool to answer questions about case B. |
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| Case B then Case A | Experimental | Participant will first review and answer questions about Case B without using the tool. Then, they will use the tool to answer questions about case A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Support Tool | Behavioral | The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Recommend Feeding Therapy | After reading a feeding case study, early intervention professionals will answer the question "Would you recommend feeding therapy?" with two choices: yes or no. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | Immediately after reading feeding case study, within approximately 5 minutes |
| Number of Participants That Recommend Referral to Other Providers | After reading a feeding case study, early intervention professionals will answer the question "Would you refer this family to any other providers/specialists for evaluation/treatment?" with two answer choices: yes or no. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | Immediately after reading feeding case study, within approximately 5 minutes |
| Number of Participants That Recommend Referral by Specialty | After reading the feeding case study, early intervention professionals will answer the question "What other professionals would you refer this child to? Check all that apply." with the following choices: nutritionist/dietician, gastroenterologist, otolaryngologist (ENT), aerodigestive clinic, pulmonologist, occupational therapist, speech language pathologist, psychologist/social worker, applied behavior analyst (ABA), or allergist. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | Immediately after reading feeding case study, within approximately 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week | After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "With what frequency would you recommend therapy?" with three choices: 2 times per week or more, 1 time per week, less than one time per week. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelsey Thompson, MS | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28851459 | Background | Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
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9 to 36 months following publication
The investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with the University of North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Case A Then Case B | Participant will first review and answer questions about Case A without using the tool. Then, they will use the tool to answer questions about case B. Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. |
| FG001 | Case B Then Case A | Participant will first review and answer questions about Case B without using the tool. Then, they will use the tool to answer questions about case A. Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Read 1st Case Study Without Tool |
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| Read 2nd Case Study With Tool |
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| ID | Title | Description |
|---|---|---|
| BG000 | Case A Then Case B | Participant will first review and answer questions about Case A without using the tool. Then, they will use the tool to answer questions about case B. Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were not collected from any participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Recommend Feeding Therapy | After reading a feeding case study, early intervention professionals will answer the question "Would you recommend feeding therapy?" with two choices: yes or no. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | Participant responses to Case A and Case B were analyzed separately. | Posted | Count of Participants | Participants | Immediately after reading feeding case study, within approximately 5 minutes |
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From the time of signing the informed consent through survey completion, an average of 10 minutes.
Provider responses were monitored weekly for any concerning responses for this survey study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Case A With Decision Support Tool | Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Thompson, MS | University of North Carolina at Chapel Hill | 919-966-1007 | kelsey_thompson@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2022 | Mar 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2021 | Mar 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D019959 | Feeding and Eating Disorders of Childhood |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Therapists will answer clinical questions about a case study (A or B, randomized order of presentation) without using the tool. They will then be presented with the tool and will answer the same clinical questions about a second case study (A or B, randomized order of presentation)
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| Immediately after reading feeding case study, within approximately 5 minutes |
| Number of Participants That Recommend Intervention Target Choices | After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "What therapy targets might you include for this child?" and may check all that apply from the following choices: oral motor skills, sensory, behavioral, medication, modification of food/liquid, modification of equipment (seating, utensils, etc.), modification of environment (location, distractions, routine, etc.), parent coaching, or other. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | Immediately after reading feeding case study, within approximately 5 minutes |
| Decision Support Tool Acceptability Score | The Acceptability of Intervention Measure (AIM) will be used to measure acceptability of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) meets my approval; (Intervention) is appealing to me; I like (Intervention) and I welcome (Intervention). | Immediately after using tool, within approximately 5 minutes |
| Decision Support Tool Appropriateness Score. | The Intervention Appropriateness Measure (IAM) will be used to measure appropriateness of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems fitting; (Intervention) seems suitable; (Intervention) seems applicable; (Intervention) seems like a good match. | Immediately after using tool, within approximately 5 minutes |
| Decision Support Tool Feasibility Score. | The Feasibility of Intervention Measure (FIM) will be used to measure feasibility of use of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems implementable; (Intervention) seems possible; (Intervention) seems doable; (Intervention) seems easy to use. | Immediately after using tool, within approximately 5 minutes |
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| BG001 | Case B Then Case A | Participant will first review and answer questions about Case B without using the tool. Then, they will use the tool to answer questions about case A. Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Year of Graduation For Clinical Degree | One participant did not report this data. | Count of Participants | Participants |
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| Years of Pediatric Feeding Experience | Count of Participants | Participants |
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| OG001 |
| Without Decision Support Tool |
Unaided by Decision Support Tool |
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| Primary | Number of Participants That Recommend Referral to Other Providers | After reading a feeding case study, early intervention professionals will answer the question "Would you refer this family to any other providers/specialists for evaluation/treatment?" with two answer choices: yes or no. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | Participant responses to Case A and Case B were analyzed separately. | Posted | Count of Participants | Participants | Immediately after reading feeding case study, within approximately 5 minutes |
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| Primary | Number of Participants That Recommend Referral by Specialty | After reading the feeding case study, early intervention professionals will answer the question "What other professionals would you refer this child to? Check all that apply." with the following choices: nutritionist/dietician, gastroenterologist, otolaryngologist (ENT), aerodigestive clinic, pulmonologist, occupational therapist, speech language pathologist, psychologist/social worker, applied behavior analyst (ABA), or allergist. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | The question was only answered by those participants who recommended referring to another professional. Participant responses to Case A and Case B were analyzed separately. | Posted | Count of Participants | Participants | Immediately after reading feeding case study, within approximately 5 minutes |
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| Secondary | Number of Participants That Recommend Feeding Therapy Categorized by Number of Times Per Week | After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "With what frequency would you recommend therapy?" with three choices: 2 times per week or more, 1 time per week, less than one time per week. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | The question was only answered by those participants who recommended feeding therapy. Participant responses to Case A and Case B were analyzed separately. | Posted | Count of Participants | Participants | Immediately after reading feeding case study, within approximately 5 minutes |
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|
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| Secondary | Number of Participants That Recommend Intervention Target Choices | After reading the feeding case study, early intervention professionals who recommended feeding therapy will answer the question "What therapy targets might you include for this child?" and may check all that apply from the following choices: oral motor skills, sensory, behavioral, medication, modification of food/liquid, modification of equipment (seating, utensils, etc.), modification of environment (location, distractions, routine, etc.), parent coaching, or other. Difference in agreement between early intervention professionals using the decision support tool and those not will be calculated and compared for cases A and B. | The question was only answered by those participants who recommended feeding therapy. Participant responses to Case A and Case B were analyzed separately. | Posted | Count of Participants | Participants | Immediately after reading feeding case study, within approximately 5 minutes |
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| Secondary | Decision Support Tool Acceptability Score | The Acceptability of Intervention Measure (AIM) will be used to measure acceptability of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) meets my approval; (Intervention) is appealing to me; I like (Intervention) and I welcome (Intervention). | Posted | Mean | Standard Deviation | score on a scale | Immediately after using tool, within approximately 5 minutes |
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| Secondary | Decision Support Tool Appropriateness Score. | The Intervention Appropriateness Measure (IAM) will be used to measure appropriateness of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems fitting; (Intervention) seems suitable; (Intervention) seems applicable; (Intervention) seems like a good match. | Posted | Mean | Standard Deviation | score on a scale | Immediately after using tool, within approximately 5 minutes |
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| Secondary | Decision Support Tool Feasibility Score. | The Feasibility of Intervention Measure (FIM) will be used to measure feasibility of use of the decision support tool. This tool includes four items, rated on a five-point Likert scale from completely disagree to completely agree, and will be quantified with a score of 0 for completely disagree, 1 for disagree, 2 for neither agree nor disagree, 3 for agree, and 4 for completely agree. The average score across the four items will be calculated, with higher scores indicating higher acceptability of the decision making tool. The minimum score is 0 and the maximum score is 4. Items on this measure include: (Intervention) seems implementable; (Intervention) seems possible; (Intervention) seems doable; (Intervention) seems easy to use. | Posted | Mean | Standard Deviation | score on a scale | Immediately after using tool, within approximately 5 minutes |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Case B With Decision Support Tool | Decision Support Tool: The decision support tool is an observational checklist with recommendations for specific specialist referrals based on what the provider observed during the feeding evaluation. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Case A Without Decision Support Tool | Unaided by Decision Support Tool | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Case B Without Decision Support Tool | Unaided by Decision Support Tool | 0 | 28 | 0 | 28 | 0 | 28 |
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| D000091642 | Urogenital Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| 2000-2009 |
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| 2010-2019 |
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| 2020 or later |
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| 6-8 years |
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| 9-11 years |
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| 12 or more years |
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| Case A-"No" response |
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| Case B-"Yes" response |
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| Case B-"No" response |
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| Case A-Gastroenterologist |
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| Case A-Otolaryngologist (ENT) |
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| Case A-Aerodigestive clinic |
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| Case A-Pulmonologist |
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| Case A-Occupational therapist and speech language pathologist |
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| Case A-Psychologist/social worker |
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| Case A-Applied behavior analyst (ABA) |
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| Case A-Allergist |
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| Case A-Multi-disciplinary team |
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| Case A-Other |
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| Case B-Nutritionist/dietician |
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| Case B-Gastroenterologist |
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| Case B-Otolaryngologist (ENT) |
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| Case B-Aerodigestive clinic |
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| Case B-Pulmonologist |
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| Case B-Occupational therapist and speech language pathologist |
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| Case B-Psychologist/social worker |
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| Case B-Applied behavior analyst (ABA) |
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| Case B-Allergist |
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| Case B-Multi-disciplinary team |
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| Case B-Other |
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| Case A-1 time per week |
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| Case A-less than one time per week |
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| Case B-2 times per week or more |
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| Case B-1 time per week |
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| Case B-less than one time per week |
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| Case A-Sensory |
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| Case A-Behavioral |
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| Case A-Medication |
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| Case A-Modification of food/liquid |
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| Case A-Modification of Equipment |
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| Case A-Modification of Environment |
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| Case A-Parent Coaching |
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| Case A-Other |
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| Case B-Oral Motor Skills |
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| Case B-Sensory |
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| Case B-Behavioral |
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| Case B-Medication |
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| Case B-Modification of food/liquid |
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| Case B-Modification of Equipment |
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| Case B-Modification of Environment |
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| Case B-Parent Coaching |
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| Case B-Other |
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