School Readiness in Preschool-Aged Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age36-71
SponsorTexas Scottish Rite Hospital for Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ages 3 years to 5 years 11 months
unilateral cerebral palsy
ability to visually attend to objects
demonstrates an interest in objects
Disqualifiers
uncontrolled epilepsy
significant visual impairment
severe behavioral problems
inability to complete the assessment protocol
Trial design
Design model
Single group
Treatments tested in this trial
Smart Start - School Readiness Program
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: School Readiness Intervention ProgramExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-interventionSecondary outcomes
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.
Time frame
pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention2
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.
Time frame
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.
Time frame
pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]Other outcomes
1
Demographic information
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)2
Gross Motor Function Classification System (GMFCS)
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)3
Manual Ability Classification Scale (MACS)
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)4
Communication Function Classification System (CFCS)
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)Sponsors and contacts
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Source ClinicalTrials.gov