An interventional study of Unstuck and On Target for Early Childhood in Executive Function Deficits (EFD), sponsored by Children's National Research Institute. Not yet recruiting. Open to participants aged 4 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Children's National Research Institute · Not applicable, Interventional, and Treatment
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:
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].
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
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Exclusion Criteria:
Behavioral: Unstuck and On Target for Early Childhood
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.
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)
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.
Time frame: Enrollment to end of intervention (8-20 weeks)
Child Behavior Rating Scale
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.
Time frame: Enrollment to end of intervention (8-20 weeks)
Behavior Rating Inventory of Executive Function
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
Time frame: Enrollment to end of intervention (8-20 weeks)
Differential Ability Scales-II: Pattern Construction
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.
Time frame: Enrollment to end of intervention (8-20 weeks)
Teacher Executive Function Classroom Knowledge Survey
Assessment of teachers' knowledge of executive function, using multiple choice. Higher total scores indicate more knowledge of executive function.
Time frame: Enrollment to end of intervention (8-20 weeks)
Unstuck-EC Knowledge Survey
Multiple choice assessment of teacher knowledge of intervention strategies. Higher scores indicate greater knowledge.
Time frame: Enrollment to end of intervention (8-20 weeks)
Unstuck-EC Self-Reported Strategy Use Survey
Teacher report of their own use of Unstuck-EC strategies. Higher scores indicate more use of of Unstuck-EC strategies.
Time frame: Enrollment to end of intervention (8-20 weeks)
No study locations are listed for this record.
Plan to share: Yes — De-identified participant-level data will be uploaded at the end of the award period to the NIMH National Data Archive (NDA). Data to be submitted to the NDA includes, but is not limited to, scores on key standardized instruments and survey measures (BRIEF-P/BRIEF-2; DAS-II: Pattern Construction; CBRS; SDQ [Teacher, Caregiver]; Single Item Stress Question; and Teacher Sense of Efficacy Scale) as well as relevant sociodemographic data. Where our data aligns with defined data structures within the NDA, we will utilize the NDA Data Dictionary and defined data structures for collection and management of our data.
Time frame: De-identified participant-level data will be uploaded at the end of the award period to the NIMH National Data Archive (NDA).
Access criteria: Researchers with access to the NIMH NDA will be able to access IPD.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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