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Unilateral Cerebral PalsyNCT06083220

School Readiness in Preschool-Aged Children With Cerebral Palsy

A study testing Smart Start - School Readiness Program in people with Unilateral Cerebral Palsy and School Readiness, run by Texas Scottish Rite Hospital for Children at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 36 to 71 months
Conditions the study is for
Unilateral Cerebral Palsy, School Readiness
What is being tested?
Smart Start - School Readiness Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
12 Dec 2023to 11 Jul 2025
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 36 to 71 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • uncontrolled epilepsy
  • significant visual impairment
  • severe behavioral problems
  • inability to complete the assessment protocol

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Scottish Rite for Children

    Frisco, Texas, 75034

Other trials in United States

About this study

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:

  1. Is it feasible to implement an intensive school readiness program for preschool-aged children with UCP?
  2. Is the program acceptable to the children and their caregivers?
  3. 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.

Read the 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. 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". 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. 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". Preschool-age children with CP perform significantly lower than their typically developing peers in the areas of mobility, self-care, social function, and communication. 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. 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. School readiness is the 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. 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. 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 a 64 hour 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 complete 64 hours of intervention focused on school readiness. 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.

Being tested
Smart Start - School Readiness Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart Start - School Readiness ProgramBehavioural

    Participants will complete 64 hours of intervention focused on goal directed school readiness. 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.

Study groups in NCT06083220
Study groupRoleWhat they receive
School Readiness Intervention ProgramExperimentalThe School Readiness Program is a 64 hour 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 the 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.
Receives: Behavioral: Smart Start - School Readiness Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Secondary outcomes (3)
  1. 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.

    Measured: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

  2. 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.

    Measured: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]

  3. 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.

    Measured: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start12 Dec 2023
  3. Primary completion11 Jul 2025
  4. Study completion11 Jul 2025

Resources

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
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06083220
Sponsor's protocol ID
STU-2023-1016
Status last verified
Oct 2026
First submitted
6 Oct 2023
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001.

    PubMed 21122742
  • Bourke-Taylor HM, Cotter C, Lalor A, Johnson L. School success and participation for students with cerebral palsy: a qualitative study exploring multiple perspectives. Disabil Rehabil. 2018 Sep;40(18):2163-2171. doi: 10.1080/09638288.2017.1327988. Epub 2017 May 19.

    PubMed 28524702
  • Boyd RN, Novak I, Morgan C, Bora S, Sakzewski L, Ware RS, Comans T, Fahey MC, Whittingham K, Trost S, Pannek K, Pagnozzi A, Mcintyre S, Badawi N, Smithers Sheedy H, Palmer KR, Burgess A, Keramat A, Bell K, Hines A, Benfer K, Gascoigne-Pees L, Leishman S, Oftedal S. School readiness of children at high risk of cerebral palsy randomised to early neuroprotection and neurorehabilitation: protocol for a follow-up study of participants from four randomised clinical trials. BMJ Open. 2023 Feb 27;13(2):e068675. doi: 10.1136/bmjopen-2022-068675.

    PubMed 36849209
  • Gehrmann FE, Coleman A, Weir KA, Ware RS, Boyd RN. School readiness of children with cerebral palsy. Dev Med Child Neurol. 2014 Aug;56(8):786-93. doi: 10.1111/dmcn.12377. Epub 2014 Jan 16.

    PubMed 24433312

Questions about this trial

What is this clinical trial studying?

A study testing Smart Start - School Readiness Program in people with Unilateral Cerebral Palsy and School Readiness, run by Texas Scottish Rite Hospital for Children 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 4 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 6 Oct 2026. 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?

Canadian Occupational Performance Measure (time frame: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06083220, which also lists 4 linked publications.

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 6 Oct 2026.

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