Clinical trial NCT05135728: Development and Pilot Testing of a Novel Preschool Executive Function Curriculum
Official title: Development and Pilot Testing of a Novel Preschool Executive Function Curriculum Development of an Executive Function Intervention for Adolescents With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Executive Dysfunction
Keywords: young children
intervention
preschool
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: AppleTree Institute
name: The Maddux School
First posted: 2021-11-26
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to academic readiness and long-term educational outcomes. Children's EF is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. Interventions targeting EF skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. We will directly target EF skills in preschoolers with poor EF. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of EF impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (DD/ED). The intervention is a downward extension of Unstuck and On Target for elementary school (UOT; Cannon, Kenworthy, Alexander, Werner, \& Anthony, 2018), an EF intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. The research team will partner with key stakeholders to revise and iteratively refine UOT-P through a development trial, utilizing participant, teacher and parent feedback. The results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (NIH, Institute of Educational Sciences, Patient-Centered Outcomes Research Institute).


Eligibility criteria: Inclusion Criteria:

Enrolled as a student at a participating school site OR as a patient at a participating clinic site

* Chronological age between 3-6 years at enrollment
* English as a primary language
* Roughly age-appropriate core language skills as determined by referring school staff or provider
* Identified by school staff or provider as having problems with flexibility

Exclusion Criteria:

No longer enrolled at participating school or clinic site

• Insufficient English fluency or language skills to complete intervention

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: Through study completion, average of 20 weeks
measure: Feasibility - Child Attendance
timeFrame: Through study completion, average of 20 weeks
measure: Acceptability of Intervention
timeFrame: Through study completion, average of 20 weeks
measure: Intervention Appropriateness
timeFrame: Through study completion, average of 20 weeks
Secondary outcomes:
measure: Fidelity Observations
timeFrame: twice throughout intervention period, average of 6 weeks between observations
measure: Interventionist Knowledge
timeFrame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Other outcomes:
measure: Child Behavior Rating Scale (CBRS)
timeFrame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
measure: Head-Toes-Knees-Shoulders Revised (HTKS-R)
timeFrame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
measure: Differential Ability Scales-II (DAS-II): Pattern Construction
timeFrame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
measure: Classroom Observations
timeFrame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
measure: Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P): Selected subscales
timeFrame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Locations:
city: Silver Spring
country: United States
facility: Children's National Hospital
state: Maryland
Study officials:
affiliation: Children's National
name: Lauren Kenworthy
role: PRINCIPAL_INVESTIGATOR
References: