Unstuck-Early Childhood Effectiveness & Implementation Trial
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?
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].
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Allison B Ratto, PhD
- Numer telefonu: 301-765-5596
- E-mail: aratto@childrensnational.org
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Usługi jak zwykle
|
|
|
Eksperymentalny: Unstuck-EC
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Early Childhood Behavior Observation of Classroom Function (EC-BOCEF)
Ramy czasowe: 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. |
From enrollment to end of treatment (8-20 weeks)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Observation of Teacher Executive Function-Supporting Strategies (OTESS)
Ramy czasowe: 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. |
Enrollment to end of intervention (8-20 weeks)
|
|
Child Behavior Rating Scale
Ramy czasowe: 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. |
Enrollment to end of intervention (8-20 weeks)
|
|
Behavior Rating Inventory of Executive Function
Ramy czasowe: 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 |
Enrollment to end of intervention (8-20 weeks)
|
|
Differential Ability Scales-II: Pattern Construction
Ramy czasowe: 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. |
Enrollment to end of intervention (8-20 weeks)
|
|
Teacher Executive Function Classroom Knowledge Survey
Ramy czasowe: 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. |
Enrollment to end of intervention (8-20 weeks)
|
|
Unstuck-EC Knowledge Survey
Ramy czasowe: Enrollment to end of intervention (8-20 weeks)
|
Multiple choice assessment of teacher knowledge of intervention strategies. Higher scores indicate greater knowledge. |
Enrollment to end of intervention (8-20 weeks)
|
|
Unstuck-EC Self-Reported Strategy Use Survey
Ramy czasowe: 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. |
Enrollment to end of intervention (8-20 weeks)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00001916
- R01MH144622 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
De-identified participant-level data will be uploaded at the end of the award period to the NIMH National Data Archive (NDA).
Kryteria dostępu do udostępniania IPD
Researchers with access to the NIMH NDA will be able to access IPD.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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