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Family Inclusive Early Brain Stimulation (FINEBRAINS)

4 de fevereiro de 2019 atualizado por: Dr. A.O. Adebiyi, University of Ibadan
Social interaction (in the form of serve and return exchanges) between child and parent are crucial for psychosocial, physical and cognitive development. Parents in sub-Saharan countries are ill-equipped to maximize the benefits from this interaction. The investigators approach builds on the traditional outlook that "it takes a village to raise a child" i.e., not only the parents but other extended family members play a role as caregivers to young children. The investigators intention is to use the existing post-natal/child welfare clinics to deliver an intervention, which uses culturally acceptable videos and active skills building, to deliver health messages and practical skills to women, with the intention that they will subsequently engage and teach their partners and other caregivers about early brain stimulation and child development.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

A two arm cluster randomized control design will be used to select a total of about 400 participants each of the control and intervention groups. The participants will be drawn from primary health care (PHC) centres offering immunization services in Ibadan. In the intervention group, mothers will be trained on early brain stimulation using group video sessions followed by individualised question and answer sessions. These sessions will take place at 6 week and 10 week post natal immunisation visits. The control arm will receive the standard of care - routine immunization care- group health talks.

The child's development will be assessed using the Survey of Wellbeing of Young Children (SWYC) instrument.

Outcome variables will include changes in self-reported early child brain stimulation behaviour and increase in the awareness of parents and significant others on the social and emotional difficulties of children.

Tipo de estudo

Intervencional

Inscrição (Real)

480

Estágio

  • Não aplicável

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 semana a 1 mês (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • All mothers with live children aged 1-6 weeks

Exclusion Criteria:

  • Mothers of children with moderate to severe birth asphyxia or gross congenital anomalies
  • Mothers who are unable to communicate to provide information

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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: A: Edutainment based intervention
This group receives the usual routine immunization at 6, 10, 14 weeks and 9 months and an Edutainment intervention package of limited group (i.e., 3-5 women) drama based video session (Edutainment) followed by a Question and Answer session with mothers on early brain development, parenting skills, communication and negotiating skills at 6 weeks. Mothers will be encouraged to train fathers and other caregivers at home with reinforcement of key messages at subsequent clinic visits. Key messages will be delivered through the use of flip charts at 14 weeks and given to mothers as take home for use in engaging the fathers partners and other caregivers for their child. Reinforcement of key messages at subsequent visits will be through the use of videos and flip chart.
Comportamental: Edutainment based intervention
Edutainment intervention package
Sem intervenção: B
This group receives routine immunization care (usually includes group health talk) at 6, 10, 14 weeks and 9 months.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reduction in socio-cognitive deficit as measured by the Survey of Well being of Young Children (SWYC)
Prazo: 6weeks, 14 weeks, 9months, 12 months and 18 months
Reduced socio-cognitive deficit in the intervention compared to the control group at 18 months of age
6weeks, 14 weeks, 9months, 12 months and 18 months
Improved child stimulation practices as measured by assessment of study constructed self-reported child stimulation practices questionnaire
Prazo: 18 months
Improved child stimulation practices in the intervention compared to the control group at 18 months of age
18 months
Number of children with developmental delays as measured by The WHO head circumference growth curves and WHO Child Growth Standards
Prazo: 6weeks to 18 months
Appropriate for Age physical development of children such as Head circumference, Length/height, Weight for Age as measured by The WHO head circumference growth curves and WHO Child Growth Standards
6weeks to 18 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Increased mothers knowledge and competence on child brain stimulation practices as measured by a study constructed domain based questionnaire on knowledge and competence instrument
Prazo: 9mths -12 months
An increase in mothers knowledge and competence on child brain stimulation practices
9mths -12 months
Mothers engagement of fathers and other caregivers on early brain stimulation as measured by simple questionnaire on mothers self-reported father engagement activity
Prazo: 6-18months
Mothers are expected to effectively engage their male partners and other caregivers on child development. This will be demonstrated by their success at getting their male partner and other caregivers trained at home.
6-18months
fathers' self- reported engagement and investment in the early childhood development as measured by study derived adaptations of the "Self-Perceptions of the Parental Role scale (SPPR)" and the Early Childhood Study Survey Tool
Prazo: 18 months
fathers' self- reported engagement and investment in the early childhood development would improve (responsible behaviour, emotional engagement, physical accessibility, material support, involvement in child care, influence in child rearing decisions)
18 months
Increased knowledge and competence of health workers on early brain stimulation as measured by study derived composite questionnaire on knowledge and competence on intervention
Prazo: 14weeks - 9months
The competence and knowledge of health workers to successfully deliver intervention this intervention after being trained would also be a secondary measure of success.
14weeks - 9months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Ibadan

Colaboradores

Grand Challenges Canada

Investigadores

  • Investigador principal: Akindele O Adebiyi, MBchB, MPH, College of Medicine, University of Ibadan

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

1 de novembro de 2014

Conclusão Primária (Real)

1 de agosto de 2016

Conclusão do estudo (Real)

1 de agosto de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

22 de fevereiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de fevereiro de 2016

Primeira postagem (Estimativa)

3 de março de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de fevereiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de fevereiro de 2019

Última verificação

1 de fevereiro de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • AD/13/479/741

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Decision would be based on research teams final decision after the crucial manuscripts have been published

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Estimulação Cerebral

Ensaios clínicos em Edutainment based intervention

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