Gaining Real-Life Skills Over the Web (GROW)
7 de março de 2022 atualizado por: Children's Hospital Medical Center, Cincinnati
Gaining Real-Life Skills Over the Web (GROW)
Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries.
GROW is designed to promote family and child coping and adjustment for caregivers.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and their families.
The incidence of TBI peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period.
To address the unmet need of caregivers of infants and toddlers with TBI, the project uses a three-phase development process to generate proof of concept and initial proof of product.
Phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight).
During Phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing.
Phase 3 involves a pilot of the GROW program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.
Tipo de estudo
Intervencional
Inscrição (Real)
18
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
1 segundo a 4 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age at injury and enrollment: ages 0-4, inclusive
- Overnight hospitalization for traumatic brain injury
- Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
- Language: English must be the primary spoken language in the home
Exclusion Criteria:
- Does not reside with the caregiver at least half-time
- The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
- English is not the primary language spoken in the home
- Families of children who are non-responsive or in a persistent vegetative state will also be excluded
- Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
- If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: GROW Intervention
Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.
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The highly interactive GROW Program consists of 5 core modules and 1 optional, supplemental session.
Each session is expected to take 15-20 minutes to complete, and at the end of each module, parents record a 5 minute "special play time" video interacting with their child to demonstrate the skills they learned in the session.
Each online module is followed by a meeting with a trained therapist who will discuss their "special play time" video and the skills they are learning.
Parents make their way through the 5 core modules sequentially before accessing the supplemental session that may be relevant to them.
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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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Center for Epidemiologic Studies Depression(CES-D) Scale Change
Prazo: Pre-Intervention and Immediately Post-Intervention
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Measuring caregiver psychological distress, the CES-D consists of 20 items that are rated on a 4-point likert scale (from 1: rarely or none of the time to 4: most or all of the time).
Scores range from zero to sixty.
Higher scores indicated a higher frequency of depressive symptoms during the last week.
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Pre-Intervention and Immediately Post-Intervention
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Parenting Stress Index (PSI) Change
Prazo: Pre-Intervention and Immediately Post-Intervention
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The study team used the 36 item short form PSI to measure caregiver stress.
Using a 4-point likert scale, the stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
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Pre-Intervention and Immediately Post-Intervention
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Patient-Reported Outcomes Measurement Information System Change
Prazo: Pre-Intervention and Immediately Post-Intervention
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The study team used only the Sleep, Stress, and Anxiety Measures which are rated on a 5-point likert scale.
Each measure has a range in score from 7 to 35 with higher scores indicating greater severity.
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Pre-Intervention and Immediately Post-Intervention
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Family Burden of Injury Interview (FBII) Change
Prazo: Pre-Intervention and Immediately Post-Intervention
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The FBII measures family burden.
Open-ended answers are coded Yes/No and are given a stress rating of 0 (not at all)-5(extremely stressful).
Caregiver responses are averaged to provide an index of injury-related family burden.
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Pre-Intervention and Immediately Post-Intervention
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MacArthur-Bates Communicative Development Inventories (MB-CDI) Change
Prazo: Pre-Intervention and Immediately Post-Intervention
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Using the short form MB-CDIs to measure child language abilities, the scoring scale is a minimum of 0- maximum of 310 with greater scores showing better language abilities.
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Pre-Intervention and Immediately Post-Intervention
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Caregiver-Child Observation Change
Prazo: Pre-Intervention and Immediately Post-Intervention
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Using the Parent/Child Toy Play Ratings in the Play and Learning Strategies (PALS) manual, 6 domains (warmth, contingent responsiveness, demonstration/physical teaching, verbal stimulation/scaffolds, restrictions, and negativity/intrusiveness) are rated on scales of 1 to 5 with 1 being the worst rating and 5 being the best.
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Pre-Intervention and Immediately Post-Intervention
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GROW Satisfaction Survey
Prazo: Immediately Post-Intervention
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Satisfaction with intervention measured in both 5-point likert scale ratings (with higher values showing greater satisfaction) and open-ended feedback about participant experience in the program.
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Immediately Post-Intervention
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Background & Family Information Form
Prazo: Pre-Intervention
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Demographics rehabilitation services
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Pre-Intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de setembro de 2017
Conclusão Primária (Real)
30 de setembro de 2021
Conclusão do estudo (Real)
30 de setembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
30 de agosto de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de dezembro de 2021
Primeira postagem (Real)
16 de dezembro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de março de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de março de 2022
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 90IFDV0003
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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