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School-Age Children With Autism With Limited Expressive Language Skills

9 de março de 2021 atualizado por: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study

This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).

Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

13

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

  • Estados Unidos
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21211
        • Kennedy Krieger Institute

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

4 anos a 7 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, & Risi, 1999)
  • Chronological age between 4.0 years and 7 years, 11 months
  • Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
  • Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid & Miller, 2007)
  • Children have participated in and completed follow-up testing for the ICAN study.

Exclusion Criteria:

  • Major medical conditions other than autism (e.g., genetic disorders [e.g., Fragile X, Down syndrome, tuberous sclerosis], blindness or deafness, and motor disabilities such as cerebral palsy;
  • Uncontrolled seizures;
  • Self-injurious behavior or moderate to severe aggression.
  • Children in foster care.
  • Children who are exposed to < 50% English throughout their typical day.
  • Children currently participating in another intervention/treatment study.

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: Randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 1 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 1 week before your child begins active treatment with their interventionist.
Comportamental: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components:

  1. One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
  2. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
  3. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.
Experimental: 2 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 2 weeks before your child begins active treatment with their interventionist.
Comportamental: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components:

  1. One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
  2. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
  3. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.
Experimental: 3 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist. In this case, the duration is 3 weeks before your child begins active treatment with their interventionist.
Comportamental: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components:

  1. One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
  2. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
  3. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Baseline Spontaneous Language
Prazo: Weekly throughout the 5 month intervention (baseline and 5 months)
The number of unprompted spontaneous language during a 15min play sample.
Weekly throughout the 5 month intervention (baseline and 5 months)

Medidas de resultados secundários

Medida de resultado
Prazo
Change in Baseline Autism Diagnostic Observation Schedule
Prazo: 5 months into treatment (at completion of intervention)
5 months into treatment (at completion of intervention)
Change in Baseline Reynell
Prazo: 5 months into treatment (at completion of intervention)
5 months into treatment (at completion of intervention)
Changes in Baseline Early Social Communication Scales (ESCS)
Prazo: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
Changes in Baseline Structured Play Assessment
Prazo: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention

Colaboradores e Investigadores

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

Patrocinador

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Colaboradores

National Institute of Mental Health (NIMH)

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 janeiro de 2012

Conclusão Primária (Real)

1 de dezembro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

6 de fevereiro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de fevereiro de 2012

Primeira postagem (Estimativa)

9 de fevereiro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NA_00049467
  • 3R01MH085048-03S1 (Concessão/Contrato do NIH dos EUA)

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