20 Participants Needed

School Readiness Program for Cerebral Palsy

AS
Overseen ByAngela Shierk, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Texas Scottish Rite Hospital for Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program called Smart Start, designed to prepare preschool-aged children with unilateral cerebral palsy (UCP) for school. The research team aims to determine if an intensive therapy program can be effectively implemented, if children and their caregivers find it appealing, and how it affects school readiness. The program includes 64 hours of activities focused on physical, emotional, and cognitive skills. Suitable participants have UCP, can see and show interest in objects, and attempt to use their affected hand. As an unphased trial, this study provides a unique opportunity for children to benefit from innovative therapy while contributing to valuable research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this school readiness program is safe for preschool-aged children with cerebral palsy?

Research has shown that the Smart Start program, part of the School Readiness Program for children with unilateral cerebral palsy (UCP), lacks specific safety data. However, studies emphasize the program's practicality and acceptability, indicating it is designed for easy participant use.

The trial is labeled "Not Applicable" for its phase, meaning it aims to gather early insights rather than test safety like early drug trials. This suggests the program is likely low-risk, as it is educational and therapeutic, not a drug.

In summary, while specific safety data for the Smart Start program is unavailable, its focus on school readiness skills suggests it is likely safe and suitable for young children with UCP.12345

Why are researchers excited about this trial?

Researchers are excited about the School Readiness Program for young children with cerebral palsy because it takes a comprehensive approach to therapy that goes beyond physical treatments. Unlike traditional therapies that might focus solely on physical rehabilitation, this program offers an intensive 64-hour intervention addressing various domains crucial for school readiness, such as emotional well-being, social skills, communication, and cognitive development. By targeting these areas, the program aims to better prepare children for school life, offering a more holistic development pathway. This multifaceted approach could potentially lead to improved overall outcomes for children with unilateral cerebral palsy, making it a promising new avenue in the field.

What evidence suggests that the School Readiness Program is effective for improving school readiness in children with cerebral palsy?

Research has shown that intensive school readiness programs can greatly benefit preschool-aged children with unilateral cerebral palsy (UCP). Studies have found that children with cerebral palsy often struggle with communication and other skills needed for school. In this trial, the Smart Start program, central to the School Readiness Intervention Program, focuses on early support in five main areas: health and physical growth, emotional and social skills, learning methods, communication, and thinking skills. Early results suggest that programs like Smart Start can enhance school readiness by addressing these areas. While more information is needed to fully confirm its effectiveness, this approach appears promising for improving skills in children with UCP.12346

Who Is on the Research Team?

AS

Angela Shierk, PhD

Principal Investigator

Scottish Rite for Children

Are You a Good Fit for This Trial?

This trial is for preschool-aged children (3 to 5 years and 11 months old) with unilateral cerebral palsy who show interest in objects, can focus on them visually, and try to reach or grasp with the impaired arm. They must speak English. Children not meeting these criteria are excluded.

Inclusion Criteria

I can see and focus on objects.
I can try to grab things with my affected arm.
Shows interest in things or objects.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Participants complete pre-intervention assessments to evaluate baseline school readiness and other relevant measures

2 weeks
2 visits (in-person)

School Readiness Intervention

Participants engage in a 64-hour intensive therapy program focused on school readiness skills across five domains

8 weeks
Weekly sessions (in-person or virtual make-up sessions)

Post-intervention Assessment

Participants complete post-intervention assessments to evaluate the impact of the school readiness program

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for continued school readiness and adaptation to school environment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Smart Start
Trial Overview The study tests a 'Smart Start - School Readiness Program' designed for young children with unilateral cerebral palsy. It checks if the program is doable, liked by kids and caregivers, and how it affects school readiness after an intensive training period followed by assessments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: School Readiness Intervention ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Scottish Rite Hospital for Children

Lead Sponsor

Trials
23
Recruited
9,000+

Published Research Related to This Trial

The Kindy Moves program is designed to improve school readiness in preschool-aged children with cerebral palsy (CP) by providing motor-based interventions in a play environment, with a focus on functional and goal-directed activities over a 4-week period.
The study will assess the feasibility of this program by measuring goal attainment and other functional outcomes in 40 children aged 2 to 5 years, using various standardized assessments before and after the intervention.
Kindy Moves: a protocol for establishing the feasibility of an activity-based intervention on goal attainment and motor capacity delivered within an interdisciplinary framework for preschool aged children with cerebral palsy.Pool, D., Elliott, C.[2023]
A program designed for severely and profoundly handicapped children with cerebral palsy aged 5 to 9 years emphasizes the importance of a collaborative team approach involving both therapy and teaching professionals.
The study highlights the effectiveness of partnerships between university and clinical personnel in evaluating the program's impact, suggesting that teamwork is crucial for improving outcomes in this population.
Teamwork in the education of severely and profoundly handicapped cerebral palsy children.Cooksley, E.[2014]
Early referral for intervention in infants at risk of cerebral palsy (CP) is hypothesized to improve school readiness by age 4-6 years compared to standard care, based on a study involving 425 participants from four randomized trials.
The study also aims to demonstrate that early diagnosis and intervention can lead to cost savings by reducing healthcare utilization, comparing outcomes with a historical control group of 245 children diagnosed later.
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.Boyd, RN., Novak, I., Morgan, C., et al.[2023]

Citations

School Readiness in Preschool-Aged Children With ...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 ...
School readiness of children at high risk of cerebral palsy ...This study is a long-term follow-up of all domains of school readiness outcomes of children at risk of cerebral palsy who have participated in ...
School Readiness Program for Cerebral PalsyThe Smart Start treatment is unique because it focuses on early intervention to improve school readiness in children with cerebral palsy by harnessing ...
Smart Start: A School Readiness Program for Children with ...Smart Start is an intensive therapeutic program created to address school readiness skills for children with cerebral palsy. Smart Start focuses on ...
School readiness of children with cerebral palsyPreschool-aged children with CP have been shown to have less effective communication and other 'school readiness' skills compared with children ...
School readiness of children at high risk of cerebral palsy ...We hypothesise that early referral to intervention for children at-risk of CP will lead to improved school readiness at 4–6 years relative to placebo or care ...
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