Executive Function Deficits (EFD)NCT07832344
Unstuck-Early Childhood Effectiveness & Implementation Trial
A study testing Unstuck and On Target for Early Childhood in people with Executive Function Deficits (EFD), run by Children's National Research Institute.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Executive Function Deficits (EFD)
- What is being tested?
- Unstuck and On Target for Early Childhood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2027to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Changing Developmental Trajectories Through Early Executive Function Intervention in Early Childhood Education
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:
- Do special education preschool teachers find Unstuck-EC to be feasible, appropriate, and acceptable for use in their classrooms?
- Do special education preschool teachers trained in Unstuck-EC better understand and support executive function in the classroom?
- Does Unstuck-EC improve children's executive function skills?
Read more
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].
- Conditions
- Executive Function Deficits (EFD)
- Being tested
- Unstuck and On Target for Early Childhood
- Keywords
- Cognitive Behavioral Therapy, Developmental Disabilities
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstuck and On Target for Early ChildhoodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unstuck-EC | Experimental | Not described Receives: Behavioral: Unstuck and On Target for Early Childhood |
| Services as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment (8-20 weeks)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment to end of intervention (8-20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startAug 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive Function Deficits (EFD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Data collection will occur over 2 years. A waitlist control at the school level will be used. Participating schools will be randomized to either Intervention (Unstuck-EC) or Services-As-Usual Control. Schools assigned to Intervention in Year 1 will not participate in Year 2. School assigned to Services as Usual in Year 2 will be assigned to Intervention in Year 2. New schools enrolled in Year 2 will be assigned to Services as Usual and will have access to the intervention after data collection is complete.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Colorado, Denver, University of Oregon
- Responsible party
- Principal investigator, Allison Ratto, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832344
- Sponsor's protocol ID
- STUDY00001916
- Other IDs
- R01MH144622
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Developmental Trajectories Through Early Executive Function Intervention in Early Childhood Education
- ClinicalTrials.gov ID
- NCT07832344
- Acronym / sponsor ID
- STUDY00001916
- Conditions
- Executive Function Deficits (EFD)
- Keywords
- Cognitive Behavioral Therapy, Developmental Disabilities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Colorado, Denver, University of Oregon
- Study start
- Aug 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do special education preschool teachers find Unstuck-EC to be feasible, appropriate, and acceptable for use in their classrooms?
- Do special education preschool teachers trained in Unstuck-EC better understand and support executive function in the classroom?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Data collection will occur over 2 years. A waitlist control at the school level will be used. Participating schools will be randomized to either Intervention (Unstuck-EC) or Services-As-Usual Control. Schools assigned to Intervention in Year 1 will not participate in Year 2. School assigned to Services as Usual in Year 2 will be assigned to Intervention in Year 2. New schools enrolled in Year 2 will be assigned to Services as Usual and will have access to the intervention after data collection is complete.
| Arm | Type | Receives |
|---|---|---|
| Unstuck-EC | Experimental | Behavioral: Unstuck and On Target for Early Childhood |
| Services as Usual | No intervention | – |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unstuck and On Target for Early ChildhoodUnstuck 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. | Behavioural | Unstuck-EC |
Primary outcome
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.
7 secondary outcomes
Observation of Teacher Executive Function-Supporting Strategies (OTESS)
Time frame: Enrollment to end of intervention (8-20 weeks)
Child Behavior Rating Scale
Time frame: Enrollment to end of intervention (8-20 weeks)
Behavior Rating Inventory of Executive Function
Time frame: Enrollment to end of intervention (8-20 weeks)
Differential Ability Scales-II: Pattern Construction
Time frame: Enrollment to end of intervention (8-20 weeks)
Teacher Executive Function Classroom Knowledge Survey
Time frame: Enrollment to end of intervention (8-20 weeks)
Unstuck-EC Knowledge Survey
Time frame: Enrollment to end of intervention (8-20 weeks)
Unstuck-EC Self-Reported Strategy Use Survey
Time frame: Enrollment to end of intervention (8-20 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Unstuck and On Target for Early Childhood in people with Executive Function Deficits (EFD), run by Children's National Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison B Ratto, PhD (301-765-5596, aratto@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Childhood Behavior Observation of Classroom Function (EC-BOCEF) (time frame: From enrollment to end of treatment (8-20 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.