School Readiness in Preschool-Aged Children With Cerebral Palsy

NCT06083220 | Recruiting

• 1 other identifier: STU-2023-1016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Unilateral Cerebral Palsy; School Readiness

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (3)

• Developmental Assessment for Young Children, Second Edition (DAYC-2)

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

• Assisting Hand Assessment

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

• School Readiness Checklist

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

Other Outcomes (9)

• Demographic information

  within 2 weeks of start of intervention (pre-intervention)

• Gross Motor Function Classification System (GMFCS)

  within 2 weeks of start of intervention (pre-intervention)

• Manual Ability Classification Scale (MACS)

  within 2 weeks of start of intervention (pre-intervention)

Study Arms (1)

School Readiness Intervention Program

EXPERIMENTAL

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 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.

Behavioral: Smart Start - School Readiness Program

Interventions

Smart Start - School Readiness Program BEHAVIORAL

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.

School Readiness Intervention Program

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Study Sites (1)

Scottish Rite for Children

Frisco, Texas, 75034, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 21122742 BACKGROUND

• 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.

  PMID: 28524702 BACKGROUND

• 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.

  PMID: 36849209 BACKGROUND

• 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.

  PMID: 24433312 BACKGROUND

Study Officials

• Angela Shierk, PhD

  Scottish Rite for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Shierk, PhD

CONTACT

(469) 412-7172; angela.shierk@tsrh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 13, 2023
• Study Start: December 12, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)