Recruiting

Observational Study

Sponsor:

Texas Scottish Rite Hospital for Children

Code:

NCT06083220

Conditions

Unilateral Cerebral Palsy

School Readiness

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Not accepted

Interventions

Smart Start - School Readiness Program

Study Details

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. 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.

Conditions

Unilateral Cerebral Palsy

School Readiness

Study ID

NCT06083220

Start date

Dec 12, 2023

Status verified date

Apr, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: School Readiness Intervention Program

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.

Interventions

Smart Start - School Readiness Program

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.

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 ]

Central Contacts and Locations

Central contacts

Locations

Scottish Rite for Children

Recruiting

Frisco, Texas, United States, 75034

Contacts

More Information

Sponsor

Texas Scottish Rite Hospital for Children

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Scottish Rite Hospital for Children on 2025-04-08.