Unstuck-Early Childhood Effectiveness & Implementation Trial

N/ANot Yet RecruitingNCT07832344

Children's National Research Institute90 enrolled

Overview

The goal of this clinical trial is to learn if a new school-based, Tier 2 (selective) cognitive-behavioral intervention called Unstuck and On Target for Early Childhood (Unstuck-EC) can treat executive function deficits in young children (ages 4-5). Executive function is a critical set of cognitive abilities that enable individuals to demonstrate skills, effectively complete tsks, and navigate social interactions through flexible regulation of their thinking, behavior, and emotions. All children will be receiving special education services and be identified by their classroom teachers as having problems with flexibility and/or emotion regulation. Unstuck-EC consists of 16 sessions, each lasting about 20 minutes, delivered 1-2 times per week. Unstuck-EC will be adapted in this trial to be delivered by classroom teachers. The main questions it aims to answer are: 1. Do special education preschool teachers find Unstuck-EC to be feasible, appropriate, and acceptable for use in their classrooms? 2. Do special education preschool teachers trained in Unstuck-EC better understand and support executive function in the classroom? 3. Does Unstuck-EC improve children's executive function skills? Researchers will compare Unstuck-EC (N=45 participants) to a "services as usual" control (N=45 participants). This means that all children will receive usual services at school through their Individualized Education Plan and associated special education supports. Those in Unstuck-EC will also receive the intervention. Participants in both groups will be followed for the same period of time (minimum of 8 weeks). All child participants will complete a baseline assessment, which include language testing for eligibility, as well as a classroom observation and direct testing of cognitive flexibility. Additionally, parents and case managers will complete behavioral rating scales of children's executive function skills and classroom behavior. All measures will be collected again at the end of the intervention period, with the exception of language testing. Additional measures will also be completed by the teacher to examine knowledge of executive function and use of Unstuck-EC strategies and executive-function supporting strategies. Teachers will also report on their own stress and self-efficacy and will complete ratings of child expulsion risk. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Study Type

INTERVENTIONAL

Allocation

Interventions

Unstuck and On Target for Early ChildhoodBEHAVIORAL

Unstuck and On Target for Early Childhood is a cognitive-behavioral Tier 2 (selective) intervention for young children with executive function deficits. It consists of 16 sessions (\~20 minutes) delivered 1-2 times weekly. It crates a common language of self-regulatory vocabulary used across schools and families to teach children skills for making plans and thinking flexibly. It uses storybooks, music, and play, in school-delivered sessions, to build child executive function skills. It is accompanied by parent education, delivered in brief updates following each session, as well as instructional videos.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 4-5 years at time of enrollment 2. Enrolled in a participating publicly funded preschool program and eligible for special education services through an Individualized Education Program (IEP), in a classroom placement that includes children who can communicate using verbal speech 3. Ability to speak in at least short sentences and answer simple questions about removed contexts (e.g., events that occurred earlier that day) in English 4. Identified by school staff as having executive function challenges, on basis of written description of sample behaviors and nomination to study participation by school staff/teachers 5. Intact or corrected-to-normal hearing and vision 6. The parents speak and read English or Spanish with sufficient fluency for completion of consent forms and informant questionnaires, as well as understanding family educational materials. Exclusion Criteria: 1. No longer enrolled at a participating school site 2. Insufficient English fluency or language skills to complete intervention 3. Sensory, neurological, developmental, or other impairment that would prevent the child from participating in the intervention and/or completing study measures

Outcomes

Primary Outcomes

Early Childhood Behavior Observation of Classroom Function (EC-BOCEF)

Masked classroom observation of child executive function behaviors. Each behavior is rated as 0 or 1 (0 =no problem, 1 = problem). The scores on 7 behaviors are summed to a total score.

Time frame: From enrollment to end of treatment (8-20 weeks)

Secondary Outcomes

Observation of Teacher Executive Function-Supporting Strategies (OTESS)

Masked observation of teacher use of executive function supporting strategies in the classroom. The observer counts each instance of strategy use and sums these to a total score.