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NCT Number: NCT07832344

Unstuck-Early Childhood Effectiveness & Implementation Trial

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].

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Key information

Conditions

Executive Function Deficits (EFD) Developmental Disabilities Mental Disorders Neurodevelopmental Disorders

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 4-5 years at time of enrollment
  • 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
  • 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
  • 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
  • Intact or corrected-to-normal hearing and vision
  • 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

  • No longer enrolled at a participating school site
  • Insufficient English fluency or language skills to complete intervention
  • Sensory, neurological, developmental, or other impairment that would prevent the child from participating in the intervention and/or completing study measures

Treatment and study plan

Unstuck and On Target for Early Childhood

Behavioral

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Observation of Teacher Executive Function-Supporting Strategies (OTESS)

    Time frame: Enrollment to end of intervention (8-20 weeks)

    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.

  2. Child Behavior Rating Scale

    Time frame: Enrollment to end of intervention (8-20 weeks)

    Informant rating of child classroom behaviors. Each item is rated on a 1-5 Likert scale (higher scores = more prosocial/positive behavior) and summed to a total score.

  3. Behavior Rating Inventory of Executive Function

    Time frame: Enrollment to end of intervention (8-20 weeks)

    Informant rating of child executive function. Each behavior is rated on a Likert scale (0, 1, 2) and total scores are generated as age-normed T-scores where higher scores indicate greater executive function challenges

  4. Differential Ability Scales-II: Pattern Construction

    Time frame: Enrollment to end of intervention (8-20 weeks)

    Direct measure of visual-spatial problem-solving that taps executive function. Total scores are converted to age-normed T-scores, where higher scores indicate better abilities.

  5. Teacher Executive Function Classroom Knowledge Survey

    Time frame: Enrollment to end of intervention (8-20 weeks)

    Assessment of teachers' knowledge of executive function, using multiple choice. Higher total scores indicate more knowledge of executive function.

  6. Unstuck-EC Knowledge Survey

    Time frame: Enrollment to end of intervention (8-20 weeks)

    Multiple choice assessment of teacher knowledge of intervention strategies. Higher scores indicate greater knowledge.

  7. Unstuck-EC Self-Reported Strategy Use Survey

    Time frame: Enrollment to end of intervention (8-20 weeks)

    Teacher report of their own use of Unstuck-EC strategies. Higher scores indicate more use of of Unstuck-EC strategies.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison B Ratto, PhD

CONTACT

[email protected]

301-765-5596

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Colorado, Denver
  • University of Oregon

Registry information

Official study title

Changing Developmental Trajectories Through Early Executive Function Intervention in Early Childhood Education

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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