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].
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Allison B Ratto, PhD
- Número de telefone: 301-765-5596
- E-mail: aratto@childrensnational.org
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Serviços como de costume
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Experimental: Unstuck-EC
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Early Childhood Behavior Observation of Classroom Function (EC-BOCEF)
Prazo: From enrollment to end of treatment (8-20 weeks)
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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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Observation of Teacher Executive Function-Supporting Strategies (OTESS)
Prazo: 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)
|
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Child Behavior Rating Scale
Prazo: Enrollment to end of intervention (8-20 weeks)
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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
Prazo: 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)
|
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Differential Ability Scales-II: Pattern Construction
Prazo: Enrollment to end of intervention (8-20 weeks)
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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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00001916
- R01MH144622 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de IPD
De-identified participant-level data will be uploaded at the end of the award period to the NIMH National Data Archive (NDA).
Critérios de acesso de compartilhamento IPD
Researchers with access to the NIMH NDA will be able to access IPD.
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