RBR-3qqbykm Efficacy of the face-to-face STEP protocol compared to the remote one in infants at risk of developmental delay

Date of registration: 01/17/2024 ^(mm/dd/yyyy)
Last approval date : 01/17/2024 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1293-3706

• Public title:

  en

  Efficacy of the face-to-face STEP protocol compared to the remote one in infants at risk of developmental delay

  pt-br

  Eficácia do protocolo STEP presencial em comparação ao remoto em bebês com risco de atraso no desenvolvimento

• Scientific acronym:

  en

  STEP-P

  pt-br

  STEP-P

• Public acronym:

  en

  STEP-P

  pt-br

  STEP-P

• Secondaries identifiers:
  • 67884623.0.0000.5504
    Issuing authority: Plataforma Brasil
  • 6.177.034
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de São Carlos

Sponsors

• Primary sponsor: Universidade Federal de São Carlos - UFSCAR
• Secondary sponsor:
  • Institution: Universidade Federal de São Carlos - UFSCAR
• Supporting source:
  • Institution: Universidade Federal de São Carlos - UFSCAR

Health conditions

• Health conditions:

  en

  Infant, Low Birth Weight; Fetal Hypoxia

  pt-br

  Baixo peso ao nascer; Anóxia Fetal

• General descriptors for health conditions:

  en

  M01.060.703.520.520 Infant, Premature

  pt-br

  M01.060.703.520.520 Prematuridade

• Specific descriptors:

  en

  M01.060.703.520.460 Infant, Low Birth Weight

  pt-br

  M01.060.703.520.460 baixo peso ao nascer

  en

  C12.050.703.277.390 Fetal Hypoxia

  pt-br

  C12.050.703.277.390 Anóxia Fetal

Interventions

• Interventions:

  en

  This is a clinical, randomized and controlled study in parallel. Randomized by the website sealedenvelope.com, in a remote and in-person group and extracted by risk of developmental delay and risk of cerebral palsy. There will be 27 participants in each group, who will be evaluated regarding motor capacity, participation, caregiver-infant interaction, environmental enrichment and engagement. After the assessments, both groups will receive intervention focused on a specific task, environmental enrichment and participation for 10 weeks and evaluated in follow-up 6 months after the end of the intervention. Infants will be assessed for motor skills (Alberta Infant Motor Scale, Gross Motor Function Measure, The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (mobility domain), for participation (Young Children's Participation and Environment Measure); for engagement during the intervention (Measure of Engagement-Observation); regarding the caregiver/infant Interaction: (Parent-Child Early Relational Assessment); regarding environmental changes (Affordances in the Home Environment for Motor Development) and regarding the Level of depression, anxiety and caregivers' stress (Depression, Anxiety and Stress Scale).

  pt-br

  Trata-se de um estudo clínico, randomizado e controlado em paralelo. Randomizado pelo site sealedenvelope.com, em grupo remoto e presencial e extratificado por risco de atraso no desenvolvimento e risco de paralisia cerebral. Serão 27 participantes em cada grupo, que serão avaliados quanto a capacidade motora, participação, interação cuidador-lactente, enriquecimento ambiental e engajamento. Após as avaliações ambos os grupos receberão intervenção focada em tarefa específica, enriquecimento ambiental e participação por 10 semanas e avaliados em follow-up após 6 meses do término da intervenção. Os lactentes serão avaliados quanto às habilidades motoras (Alberta Infant Motor Scale, Gross Motor Function Measure, The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (domínio de mobilidade), quanto à participação (Young Children’s Participation and Environment Measure); quanto ao engajamento durante a intervenção (Measure of Engagement-Observation); quanto à Interação cuidador/lactente: (Parent-Child Early Relational Assessment); quanto às mudanças ambientais (Affordances in the Home Environment for Motor Development) e quanto ao Nível de depressão, ansiedade e estresse dos cuidadores (Depression, Anxiety and Stress Scale).

• Descriptors:

  en

  N02.421.143.130.320 Early Intervention, Educational

  pt-br

  N02.421.143.130.320 Intervenção educacional precoce

  en

  F02.808.260 Motor Skills

  pt-br

  F02.808.260 Habilidades motoras

  en

  F03.625 Neurodevelopmental Disorders

  pt-br

  F03.625 Transtornos do neurodesenvolvimento

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 10/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  54	-	3 M	9 M

• Inclusion criteria:

  en

  Infants aged between 3 and 9 months corrected age. Of both sexes. At biological risk - to be considered at risk, the infant must present at least one of the following factors: prematurity (<33 weeks of gestational age), low weight (below the 10th percentile according to gestational age and sex), asphyxia (Apgar score from 0 to 3 for more than 5 minutes, and/or neurological manifestations in the neonate such as seizures, coma or hypotonia, need for cardiorespiratory resuscitation or use of oxygen therapy, hospitalization in the Intensive Care Unit, General Movement Assessment (GMA) altered (absence of fidgety or abnormal fidgety), total score on the Hammersmith Neurological Examination (HINE), below 60 at three months, below 70 at six months and equal to or less than 73 at infants aged between nine and 12 monthsonths

  pt-br

  Lactentes de 3 a 9 meses de idade corrigida. De ambos os sexos. Com risco biológico - para ser considerado de risco o lactente deve apresentar ao menos um dos fatores a seguir: prematuridade (<33 semanas de idade gestacional), baixo peso (abaixo do percentil 10 de acordo com a idade gestacional e o sexo), asfixia (índice de Apgar de 0 a 3 por mais de 5 minutos, e/ou manifestações neurológicas no neonato como convulsões, estado de coma ou hipotonia, necessidade de reanimação cardiorrespiratória ou uso de oxigenoterapia, internação em Unidade de Terapia Intensiva, General Movement Assessment (GMA) alterado (ausência de fidgety ou fidgety anormal), escore total no Exame Neurológico de Hammersmith (HINE) abaixo de 60 aos três meses, abaixo de 70 aos seis meses e igual ou menor que 73 em lactentes entre nove e 12 meses de vida

• Exclusion criteria:

  en

  Infants with genetic abnormalities; infants who are in a hospital environment; who are blind or deaf; with a clinical diagnosis of respiratory diseases; with congenital diseases such as heart disease, kidney or ophthalmological alterations; physiologically unstable infants; infants whose primary caregivers have cognitive or motor disabilities that prevent the understanding or performance of activities administered at home or are unable to take the infant to clinics the required number of days a week; and/or do not sign the Informed Consent Form

  pt-br

  Lactentes com anormalidades genéticas; lactentes que estejam em ambiente hospitalar; que apresentem cegueira ou surdez; com diagnóstico clínico de doenças respiratórias; com enfermidades congênitas como cardiopatias, alterações renais ou oftalmológicas; lactentes fisiologicamente instáveis; lactentes cujos cuidadores principais apresentarem deficiências cognitivas ou motoras que impeçam a compreensão ou desempenho das atividades administradas em casa ou não consigam levar o lactente às clínicas a quantidade necessária de dias na semana; e/ou assinem o Termo de Consentimento Livre e Esclarecido

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  The primary outcome will be motor development, assessed by the Alberta Infant Motor Scale (AIMS), Gross Motor Function Measure (GMFM) and Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), mobility domain.

  pt-br

  O desfecho primário será o desenvolvimento motor, avaliado pela Alberta Infant Motor Scale (AIMS), Gross Motor Function Measure (GMFM) e Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), domínio mobilidade.

• Secondary outcomes:

  en

  participation, assessed by the Young Children's Participation and Environment Measure (YC-PEM)

  pt-br

  participação, avaliada pela Young Children’s Participation and Environment Measure (YC-PEM)

  en

  engagement of the infant during the intervention, through the Measure of Engagement-Observation instrument (PRIME-O),

  pt-br

  engajamento do lactente durante a intervenção, por meio do instrumento Measure of Engagement-Observation (PRIME-O),

  en

  Mother interaction -child, assessment based on the Parent-Child Early Relational Assessment (PCERA) instrument

  pt-br

  Interação mãe-filho, avaliação baseada no instrumento Parent-Child Early Relational Assessment (PCERA)

  en

  Environmental and contextual changes, assessed by the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)

  pt-br

  As mudanças ambientais e contextuais, avaliadas pela Affordances in the Home Environment for Motor Development- Infant Scale (AHEMD-IS)

  en

  Level of depression and anxiety and caregivers' stress by the Depression, Anxiety and Stress Scale (DASS-21);

  pt-br

  Nível de depressão ansiedade e estresse dos cuidadores pela Depression, Anxiety and Stress Scale (DASS-21);

  en

  Perception of caregivers regarding the evolution and achievement of goals by the Canadian Occupational Performance Measure (COPM).

  pt-br

  Percepção dos cuidadores quanto à evolução e alcance das metas pela Canadian Occupational Performance Measure (COPM

  en

  Perception of the caregiver and researcher regarding the evolution and achievement of goals by Goal Attainment Scaling (GAS).

  pt-br

  Percepção do cuidador e pesquisador quanto à evolução e ao alcance de metas pela Goal Attainment Scaling (GAS).

Contacts

• Public contact
  • Full name: Tatiane Schlichting
  • • Address: Rodovia Washington Luis, km 235, s/n,, Dep. de Fisioterapia PROEX CAPES
    • City: São Carlos / Brazil
    • Zip code: 13565-905
  • Phone: 55 (16) 3351-8341
  • Email: ppgft@ufscar.br
  • Affiliation: Universidade Federal de São Carlos - UFSCAR
   
• Scientific contact
  • Full name: Tatiane Schlichting
  • • Address: Rodovia Washington Luis, km 235, s/n,, Dep. de Fisioterapia PROEX CAPES
    • City: São Carlos / Brazil
    • Zip code: 13565-905
  • Phone: 55 (16) 3351-8341
  • Email: ppgft@ufscar.br
  • Affiliation: Universidade Federal de São Carlos - UFSCAR
   
• Site contact
  • Full name: Tatiane Schlichting
  • • Address: Rodovia Washington Luis, km 235, s/n,, Dep. de Fisioterapia PROEX CAPES
    • City: São Carlos / Brazil
    • Zip code: 13565-905
  • Phone: 55 (16) 3351-8341
  • Email: ppgft@ufscar.br
  • Affiliation: Universidade Federal de São Carlos - UFSCAR
   

Additional links:

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