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School Readiness in Preschool-Aged Children With Cerebral Palsy

Primary Purpose

Unilateral Cerebral Palsy, School Readiness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smart Start - School Readiness Program
Sponsored by
Texas Scottish Rite Hospital for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Cerebral Palsy

Eligibility Criteria

36 Months - 71 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ages 3 years to 5 years 11 months unilateral cerebral palsy ability to visually attend to objects demonstrates an interest in objects attempt to reach for or grasp an item with the impaired upper extremity English-speaking participants Exclusion Criteria: uncontrolled epilepsy significant visual impairment severe behavioral problems inability to complete the assessment protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    School Readiness Intervention Program

    Arm Description

    The School Readiness Program is an 8-week intensive therapy program focused on school readiness skills for young children with unilateral cerebral palsy (UCP). The program will include 64 hours of intervention supporting development and goal attainment across 5 school readiness domains: (1) health and physical development, (2) emotional well-being and social competence, (3) approaches to learning, (4) communication skills, and (5) cognitive skills and general knowledge.

    Outcomes

    Primary Outcome Measures

    Canadian Occupational Performance Measure
    The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10 with higher scores representing better performance and higher satisfaction)

    Secondary Outcome Measures

    Developmental Assessment for Young Children, Second Edition (DAYC-2)
    The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores) mean standard score is 100 with a standard deviation of 10. Higher values represent a better outcome.
    Assisting Hand Assessment
    The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units on a scale from 0-100). A higher score represents better outcomes.
    School Readiness Checklist
    A parent reported checklist created by the study team to rate the level of independence or mastery their child has with specific tasks within the 5 domains of school readiness (1. health and physical development, 2. emotional well-being and social competence, 3. approaches to learning, 4. communication skills, and 5. cognitive skills and general knowledge). The items on the checklists are commonly recommended by school districts to support success in kindergarten. Items are rated on a scale of 1-4. Higher values represent better outcomes.

    Full Information

    First Posted
    October 6, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Texas Scottish Rite Hospital for Children
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06083220
    Brief Title
    School Readiness in Preschool-Aged Children With Cerebral Palsy
    Official Title
    School Readiness in Preschool-Aged Children With Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas Scottish Rite Hospital for Children

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this feasibility and proof of concept study is to learn about the feasibility, acceptability, and impact of a school readiness program for preschool-aged children with unilateral cerebral palsy. The main question[s] it aims to answer are: Is it feasible to implement an intensive school readiness program for preschool-aged children with UCP? Is the program acceptable to the children and their caregivers? What is the impact of the program on school readiness? Participants will complete two pre-intervention assessments, participate in an intensive, goal directed, school readiness program, and complete 1 post-intervention assessment.
    Detailed Description
    Introduction and Purpose Cerebral Palsy (CP) is a congenital non-progressive motor disorder caused by a brain lesion that occurs in the early stages of development and persists throughout adulthood. CP is one of the most common disabilities in childhood, with a prevalence of 3.3 per 1,000 children in the United States (Arneson, 2009). It is noted that "children with disabilities have a greater risk of poor or sub-optimal development in early childhood compared to children without disabilities" (Olusanya et al., 2022). Due to the nature of CP, the child and their families can experience many limitations in their day-to-day lives and how they participate in their environment. Many of these limitations are brought to light when the child is ready to enter school. It is essential that children with CP and their families understand their child's strengths and areas of need in order to ensure that their child is offered the requisite support services that adequately prepare them for school enrolment (Olusanya et al., 2022). The purpose of this study is to determine if an intensive school readiness program for children with unilateral cerebral palsy (UCP), is feasible and acceptable, and to gain an understanding of the impact of the program on school readiness. Background "School readiness is a framework for assessing the strengths and vulnerabilities of a child prior to school" (Boyd et al., 2023). Preschool-age children with CP perform significantly lower than their typically developing peers in the areas of mobility, self-care, social function, and communication (Gehrmann et al., 2014). Because school readiness is lower in children with disabilities, underachievement and lack of social-emotional skills can further affect how the child develops into adulthood and possibly change the course of their lives (Boyd et al., 2023). There is very little research regarding school readiness programs specifically for children with cerebral palsy, but other programs that promote school readiness for children on a universal level have shown to be effective. The school readiness framework can be used to assess a child's strengths and weaknesses in the context of transitioning to entering school (Gehrmann et al., 2014). Germann et al (2014) describe school readiness as a child's ability to participate in 5 major skill areas: (1) health and physical development, (2) emotional well-being and social competence, (3) approaches to learning, (4) communication skills, and (5) cognitive skills and general knowledge. Research indicates children with disabilities encounter challenges in the school setting secondary to poor teacher training, lack of support, decreased social experience, and physical barriers (Bourke-Taylor et al., 2017). Understanding the areas that children with CP have deficits in and how we can intervene at an early age can help reduce poor academic performance as the child ages. Studies have shown that providing a school readiness program to any child, typically developing or not, not only increases success in the classroom but can also be an investment in the community's future. Boyd et al (2023) discovered that investing in school readiness programs can have a positive impact on the community for up to 60 years or more due to increased success of children at an early age carrying on into adulthood. Therefore, there is a need to develop and test a school readiness program that (1) identifies the strengths and areas in need of intervention, (2) educates caregivers on their child's strengths/needs and available resources, and (3) provides intensive therapeutic intervention aimed to address the individual school readiness goals of the child. Intervention The School Readiness Program is an 8-week intensive therapy program focused on school readiness skills for young children with unilateral cerebral palsy (UCP). The program will include 64 hours of intervention supporting development and goal attainment across 5 school readiness domains: (1) health and physical development, (2) emotional well-being and social competence, (3) approaches to learning, (4) communication skills, and (5) cognitive skills and general knowledge. Participants will meet 2 times per week (4 hours each session) for 8 weeks in a group setting. Each participant will have an interventionist who is an allied health student with a ratio of 1 child to 1 interventionist or 2 children to 1 interventionist. The interventionists will be trained and overseen by licensed occupational therapists. Each week will have a theme to promote engagement and motivation to participate (i.e. animals, outer space, etc). Each of the five domains will be addressed in each session, and the activities will be tailored to support the individual goals of the participant using a goal-directed training approach. A goal-directed training approach includes the child, caregiver, and researcher collaboratively setting goals that are meaningful to the child and their family. Intervention strategies for goal attainment will include both remediation of skills (i.e. learning to button a button) or the accommodation of skills (i.e. using Velcro instead of a button) depending on the child's goals and current ability. The primary focus of the intervention will be goal attainment related to school readiness. Sessions that are missed due to unexpected or unplanned circumstances (illness, loss of transportation, etc) can be made up via an in-person or virtual session. Caregivers will be educated on their child's diagnosis, the components of the program, and additional resources that support the child's transition into school. Caregivers will also receive a report including a summary of strengths and areas that are challenging for the child. The goal of the School Readiness program is for children with UCP to increase independence in school readiness activities and to educate the child's caregiver on topics and strategies that will promote a successful transition into school for the child.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unilateral Cerebral Palsy, School Readiness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    School Readiness Intervention Program
    Arm Type
    Experimental
    Arm Description
    The School Readiness Program is an 8-week intensive therapy program focused on school readiness skills for young children with unilateral cerebral palsy (UCP). The program will include 64 hours of intervention supporting development and goal attainment across 5 school readiness domains: (1) health and physical development, (2) emotional well-being and social competence, (3) approaches to learning, (4) communication skills, and (5) cognitive skills and general knowledge.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smart Start - School Readiness Program
    Intervention Description
    Participants will meet 2 times per week (4 hours each session) for 8 weeks in a group setting. Each of the five domains will be addressed in each session, and the activities will be tailored to support the individual goals of the participant using a goal-directed training approach. A goal-directed training approach includes the child, caregiver, and researcher collaboratively setting goals that are meaningful to the child and their family. Intervention strategies for goal attainment will include both remediation of skills (i.e. learning to button a button) or the accommodation of skills (i.e. using Velcro instead of a button) depending on the child's goals and current ability. The primary focus of the intervention will be goal attainment related to school readiness.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure
    Description
    The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10 with higher scores representing better performance and higher satisfaction)
    Time Frame
    pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Secondary Outcome Measure Information:
    Title
    Developmental Assessment for Young Children, Second Edition (DAYC-2)
    Description
    The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores) mean standard score is 100 with a standard deviation of 10. Higher values represent a better outcome.
    Time Frame
    pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
    Title
    Assisting Hand Assessment
    Description
    The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units on a scale from 0-100). A higher score represents better outcomes.
    Time Frame
    pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
    Title
    School Readiness Checklist
    Description
    A parent reported checklist created by the study team to rate the level of independence or mastery their child has with specific tasks within the 5 domains of school readiness (1. health and physical development, 2. emotional well-being and social competence, 3. approaches to learning, 4. communication skills, and 5. cognitive skills and general knowledge). The items on the checklists are commonly recommended by school districts to support success in kindergarten. Items are rated on a scale of 1-4. Higher values represent better outcomes.
    Time Frame
    pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
    Other Pre-specified Outcome Measures:
    Title
    Demographic information
    Description
    Demographic in formation will be collected including: age in years and months, gender, etiology of cerebral palsy, qualitative description of previous exposure to therapy and preschool
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Gross Motor Function Classification System (GMFCS)
    Description
    The Gross Motor Function Classification Systems is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy with 1 being the lowest functioning and 5 being the highest
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Manual Ability Classification Scale (MACS)
    Description
    The Manual Ability Classification Scale describes how children with cerebral palsy use their hands during activities of daily living with 1 being the least functional and 5 being the most functional
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Communication Function Classification System (CFCS)
    Description
    The Communication Function Classification System is used to classify the everyday communication performance of individuals with cerebral palsy into five levels. Level five has the least ability to effectively send and receive information from another person and level 1 demonstrates effective sending and receiving of information with unfamiliar and familiar people
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    The Child and Adolescent Scale of Environment
    Description
    The Child and Adolescent Scale of Environment examines the perceived impact (not frequency) of environmental problems (physical, attitudinal, and social) encountered by the child and family. The sum score range is 0-54 with higher scores representing greater extent of environmental problems.
    Time Frame
    within 2 weeks of start of intervention (pre-intervention)
    Title
    Wechsler Preschool and Primary Scales of Intelligence, 4th Edition (WPPSI-IV)
    Description
    The WPPSI-IV is a measure of cognitive development including verbal comprehension, visual-spatial, and working memory designed for children ages 2 years 6 months to 7 years 7 months. Standard scores are based on a mean of 100 with a standard deviation of 15. Higher scores represent better outcomes.
    Time Frame
    within 1 month of start of intervention (pre-intervention)
    Title
    Bracken Basic Concept Scale, 4th Edition Receptive (BBCS-4:R)
    Description
    The BBCS-4:R is a developmental assessment designed to evaluate children's school readiness skills in terms of their understanding of basic concepts that are strongly related to early childhood cognitive and language development as well as early academic achievement including colors, letters, numbers/counting, size/comparison, shapes, and self/social awareness for children ages 3 years to 7 years 11 months. Subtests have scaled scores with a mean of 10 and a standard deviation of 3, composite scores have a mean of 100 with a standard deviation of 15. Higher scores represent better outcomes.
    Time Frame
    within 1 month of start of intervention (pre-intervention)
    Title
    Feasibility and Fidelity Checklist
    Description
    a form to document intervention session attendance and to document if the key components of the intervention are being implemented on a weekly basis using a yes/no checklist
    Time Frame
    weekly during the 8 weeks of the intervention
    Title
    Participant Engagement and Acceptability Rating Form
    Description
    a form completed by the participant and their caregiver on a weekly basis to rate the acceptability of the intervention sessions and to provide feedback/recommendations for the intervention using likert scaling with 1 being a low rating and 5 being a high rating and open ended qualitative responses
    Time Frame
    weekly during the 8 weeks of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    36 Months
    Maximum Age & Unit of Time
    71 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ages 3 years to 5 years 11 months unilateral cerebral palsy ability to visually attend to objects demonstrates an interest in objects attempt to reach for or grasp an item with the impaired upper extremity English-speaking participants Exclusion Criteria: uncontrolled epilepsy significant visual impairment severe behavioral problems inability to complete the assessment protocol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela Shierk, PhD
    Phone
    (469) 412-7172
    Email
    angela.shierk@tsrh.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angela Shierk, PhD
    Organizational Affiliation
    Scottish Rite for Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    School Readiness in Preschool-Aged Children With Cerebral Palsy

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