Executive Function Play Opportunities for Children With Down Syndrome (EXPO)
Executive Function Intervention for Young Children With Down Syndrome
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children with Down syndrome (DS). At baseline, all participants will complete an assessment including laboratory-based measures of EF, parent-report measures of EF, and intensive ecological measurement of EF using the iBehavior app. Participants will then be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention, with a target total sample size of 150.
During stage 1, participants in the EXPO condition will complete 4 weeks of standard EXPO intervention. The initial weeks of EXPO consist of 2 weeks of EXPO Ready activities followed by 2 weeks of Working Memory activities, and all participants in the EXPO intervention receive ongoing support from an EXPO coach.
At the stage 1 evaluation, conducted 4 weeks after starting EXPO, all participants will complete the laboratory-based EF assessment battery. EXPO participants will be assessed for response to the intervention and classified as early or slower responders based on prespecified criteria for improvement in laboratory-based EF performance.
Early responders will be assigned to the standard EXPO intervention in stage 2 and continue with activities targeting inhibition, cognitive flexibility, planning, and consolidation of skills for a total of 12 weeks. Slower responders will be randomly assigned in a 1:1 ratio to either the EXPO Extended or EXPO Foundations pathway. The EXPO Extended pathway will include the same core activities as the EXPO standard pathway but will provide additional intervention time, for a total of 18 weeks. The EXPO Foundations pathway will begin with a block of activities targeting early social communication and regulation to provide a foundation for activity engagement, followed by more foundational versions of activities targeting inhibition and cognitive flexibility. The EXPO Foundations pathway will continue for a total of 12 weeks.
All participants will complete laboratory and parent-report measures of EF immediately post-intervention and 3 months later. Participants in the delayed-treatment control condition will not receive EXPO during the initial study period but will complete the same assessments as participants in the EXPO intervention. Following completion of the 3-month follow-up, participants in the delayed-treatment control condition will be offered the EXPO intervention.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Kaylyn Van Deusen, MS
- Número de telefone: 9704911969
- E-mail: kaylyn.van_deusen@colostate.edu
Estude backup de contato
- Nome: Miranda Pinks, MS
- Número de telefone: 970-4911969
- E-mail: miranda.pinks@colostate.edu
Locais de estudo
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Colorado
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Fort Collins, Colorado, Estados Unidos, 80523
- Colorado State University
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Investigador principal:
- Deborah Fidler, PhD
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Contato:
- Deborah Fidler, PhD
- Número de telefone: 9702194288
- E-mail: Deborah.fidler@colostate.edu
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Contato:
- Kaylyn Van Deusen, MS
- Número de telefone: 970-4911969
- E-mail: kaylyn.Van_Deusen@colostate.edu
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Subinvestigador:
- Nathaniel Riggs, Phd
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Subinvestigador:
- Susan Hepburn, PhD
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Subinvestigador:
- Lisa Daunhauer, ScD
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CO
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Padova, CO, Itália, 80526
- University of Padova
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Contato:
- Silvia Lanfranchi, PhD
- Número de telefone: 9702194288
- E-mail: silvia.lanfranchi@unipd.it
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- confirmed medical diagnosis of Down syndrome
Exclusion Criteria:
- no complete hearing or vision loss
- primary exposure to English or Italian
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Delayed-Treatment Control
Participants do not receive EXPO during the initial study period and complete the same EF assessments as participants in the EXPO intervention pathways.
Participants are offered the EXPO intervention following completion of the 3-month follow-up.
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Experimental: EXPO Standard Pathway
Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.
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EXPO is a novel intervention that targets the development of EF through play-based opportunities for children with DS and their primary caregivers.
EXPO is a 'syndrome-informed' intervention in that all activities are tailored to phenotypic strengths and challenges associated with DS, accounting for cognitive, language, and motor presentations frequently observed in this population.
EXPO is also designed to elicit maximal engagement and enjoyment for children and their caregivers by embedding opportunities to strengthen EF component processes in the context of play and games.
Outros nomes:
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Comparador Ativo: Adaptive Pathway 1/EXPO Extended
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Extended.
EXPO Extended provides the standard pathway activities with an extended 18-week schedule.
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Alternative EXPO pathway that extends the length of the EXPO intervention from 12 to 18 weeks to provide more time and opportunity for skill acquisition.
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Comparador Ativo: Adaptive Pathway 2/EXPO Foundations
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Foundations.
EXPO Foundations provides a more foundational pathway with simplified activities, and additional activities that emphasize early communication and regulatory processes.
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An augmented version of EXPO that places a greater emphasis on precursors to EXPO activity engagement, including an increased number of social routine activities, enhanced presses for social communication behaviors like joint attention, enhanced focus on early self-regulation skills, and adaptations of all EXPO activities in each block that emphasize more foundational aspects of play.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Adapted Reverse Categorization
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Rule switch task that involves sorting by color, and then reversing the sort rule
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From enrollment to the end of treatment, with a 3-month follow-up
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Zoo Animal Switch
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Rule switch task that involves sorting large and small animal pairs by size into large and small buckets, then reversing the rule to put large animals into the small bucket, and small animals into the large bucket
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From enrollment to the end of treatment, with a 3-month follow-up
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Developmental Profiles-4 Cognitive domain
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Growth Scale Values in the Developmental Profiles-4 Cognitive domain
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From enrollment to the end of treatment, with a 3-month follow-up
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Developmental Profiles-4 Social-emotional domain
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
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From enrollment to the end of treatment, with a 3-month follow-up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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iBehavior Ecological Momentary Assessment
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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From enrollment to the end of treatment, with a 3-month follow-up
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Self ordered pointing: Garage Game
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Self-ordered pointing task that requires working memory/updating
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From enrollment to the end of treatment, with a 3-month follow-up
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BRIEF-Preschool Inhibition Domain
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Standardized Caregiver Report of Executive Functioning for Preschool aged children
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From enrollment to the end of treatment, with a 3-month follow-up
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Hearts and Flowers
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Opposites task that involves matching cards to the opposite type of card
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From enrollment to the end of treatment, with a 3-month follow-up
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Developmental Profiles-4 Adaptive Behavior domain
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain
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From enrollment to the end of treatment, with a 3-month follow-up
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Building Task
Prazo: From enrollment to the end of treatment, with a 3-month follow-up
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Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner
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From enrollment to the end of treatment, with a 3-month follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Deborah Fidler, Colorado State University
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
- 7190 (CTEP)
- R61HD115161 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Upon completion of this study, and annually throughout the thre-year project period, our team will share all developmental and behavioral with the NIH INCLUDE Data Coordinating Center.
Data will also be collected from a parent or guardian via questionnaire and the iBehavior smartphone application. Data that will be preserved and shared include demographic information, developmental assessments composite scores, caregiver rating composite scores for behavioral dimensions, and caregiver-reported iBehavior composite data. The data transformation approach for all aggregate-level data will be specified in detail in a protocol manual for reproducibility. Information regarding data content, format, and organization will be available to any research colleagues accessing the DCC database. All shared data will be formatted in accordance with current standards and norms in the field of
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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