Mecanismos fisiológicos dos efeitos da intervenção da equitação terapêutica em uma população psiquiátrica de jovens com TEA
24 de julho de 2026 atualizado por: University of Colorado, Denver
Mecanismos Fisiológicos de Ação Relacionados aos Efeitos de Intervenção de Equitação Terapêutica Imediata e de Longo Prazo em uma População Psiquiátrica de Jovens com Transtorno do Espectro Autista
Este estudo randomizado de controle (RCT) procura avaliar os mecanismos subjacentes à Equitação Terapêutica (THR) anteriormente observados efeitos positivos significativos em jovens com TEA, particularmente aqueles com transtornos psiquiátricos co-ocorrentes, e para refinar informações sobre a durabilidade, dose e sub-população efeitos da intervenção.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
Este estudo randomizado de controle (RCT) testará a hipótese de que os padrões de resposta fisiológica do cortisol salivar, atividade cardiovascular e eletrodérmica são responsáveis por nossos resultados significativos observados anteriormente (isto é, irritabilidade e hiperatividade reduzidas e melhora social e comunicação) e resultados adicionais ( qualidade de vida do cuidador de regulação emocional e uso de cuidados de saúde mental em crise), em jovens de 6 a 16 anos.
com ASD e diagnósticos psiquiátricos co-ocorrentes randomizados para uma intervenção de THR manualizada de 10 semanas em comparação com um controle sem cavalos no celeiro (BA) (objetivo 1).
Avaliaremos a durabilidade dos resultados do objetivo 1 no grupo THR em comparação com o grupo de controle BA seis meses após o período de intervenção (objetivo 2).
Finalmente, exploraremos os efeitos da dose e da subpopulação das intervenções THR e BA comparando as diferenças de tamanho do efeito nos grupos THR e BA com (a) um grupo de controle de lista de espera de 10 semanas; (b) um grupo de intervenção Híbrida (cinco semanas de AB seguidas de cinco semanas de THR); e (c) uma subamostra da população do estudo THR randomizada após hospitalização psiquiátrica (objetivo 3).
Tipo de estudo
Intervencional
Inscrição (Real)
236
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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Colorado
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Aurora, Colorado, Estados Unidos, 80218
- University of Colorado Anschutz Medical Campus
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Maine
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Portland, Maine, Estados Unidos, 04102
- Maine Health
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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
6 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Descrição
Critério de inclusão:
- diagnóstico documentado de TEA e um transtorno psiquiátrico concomitante
- Pontuação da subescala de irritabilidade ABC ≥8
- Leiter-III QI não-verbal ≥ 40
- atender à pontuação do Symptom Criterion (número mínimo de sintomas necessários para um DSM-V (diagnóstico de humor, ansiedade ou TDAH) no CASI-5)
- atender aos limites de ASD no SCQ (≥ 11) e no ADOS-2
- Apenas uma criança com TEA por família para manter observações independentes
- um cuidador consistente (ou seja, pai ou responsável legal) para concluir as medidas de resultado do estudo
Critério de exclusão:
- problemas médicos ou comportamentais que impedem a participação
- ala do estado
- julgado durante a tela do centro de pilotagem para ter uma experiência de pilotagem significativa
- tabagismo ou uso regular de esteróides orais, inalados ou tópicos regularmente, fatores conhecidos por afetar os níveis de cortisol
- Participantes com peso igual ou superior a 200 libras serão excluídos devido às políticas de segurança do centro de equitação
- Os participantes não terão permissão para iniciar as avaliações de linha de base até que pelo menos seis meses tenham se passado desde a última vez em que se envolveram em EAAT montado, com evidência piloto para a manutenção de seis meses dos efeitos do THR.
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 Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Lista de espera
Aqueles designados para o grupo da lista de espera não terão nenhuma intervenção relacionada a cavalos durante um período de espera de 10 semanas.
Após esse período de espera e a conclusão das avaliações posteriores, os participantes nessa condição iniciarão um grupo híbrido (consulte Braço híbrido)
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Experimental: Equitação Terapêutica
Este braço é um pequeno grupo de 10 semanas e uma hora (2 a 4 participantes) liderado por um instrutor de THR.
O grupo incluirá uma atividade montada de 45 minutos para aprender habilidades de equitação, conforme descrito no manual THR do estudo.
Os horários dos grupos serão entre 13h e 17h para coleta de cortisol salivar.
Semanalmente, os participantes seguirão uma rotina consistente de usar dispositivos de atividade eletrodérmica e de monitoramento de frequência cardíaca, sentar-se em uma mesa de arte em grupo antes da aula, depois disso, a equipe do estudo instruirá os participantes a colocar o cotonete de espuma de 10 cm de comprimento sob a língua para um minuto enquanto assiste a um cronômetro de 1 minuto.
Os participantes então colocarão seus capacetes e entrarão no picadeiro.
A cada semana após a conclusão da intervenção THR, os participantes sentar-se-ão novamente com seu grupo em uma mesa de arte por 5 minutos, seguido de outra amostra de saliva.
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Equoterapia
Outros nomes:
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Comparador Ativo: Atividade no celeiro
Este braço é um pequeno grupo de 10 semanas e uma hora (2-4 participantes) liderado por um instrutor de THR e co-liderado por um profissional de saúde mental ou terapia ocupacional.
Os participantes terão um voluntário designado e não terão contato físico com os cavalos no centro hípico, apenas observarão os cavalos à distância.
Haverá um cavalo de pelúcia em tamanho real para aprendizado prático relacionado ao tópico semanal de acordo com o manual de estudo da BA.
Os horários dos grupos serão entre 13h e 17h para coleta de cortisol salivar.
Semanalmente, os participantes seguirão uma rotina consistente de usar dispositivos de atividade eletrodérmica e de monitoramento de frequência cardíaca, sentar-se em uma mesa de arte em grupo antes da aula, depois disso, a equipe do estudo instruirá os participantes a colocar o cotonete de espuma de 10 cm de comprimento sob a língua para um minuto enquanto assiste a um cronômetro de 1 minuto.
A cada semana após a conclusão da intervenção BA, os participantes sentar-se-ão novamente com seu grupo em uma mesa de arte por 5 minutos, seguido de outra amostra de saliva.
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Grupo de equitação
Outros nomes:
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Experimental: Híbrido
Os participantes que concluírem o braço da lista de espera e as avaliações posteriores iniciarão um grupo híbrido entre 13h e 17h.
O grupo consiste em um pequeno grupo de BA de 5 semanas e 1 hora (2-4 participantes) liderado por um instrutor de THR e co-liderado por um conselheiro de saúde mental ou TO.
Os participantes terão um voluntário designado e não terão contato físico com os cavalos no centro hípico, apenas observarão os cavalos à distância.
Haverá um cavalo de pelúcia em tamanho real para o aprendizado prático de tópicos semanais de acordo com o manual de estudo da BA.
Grupo.
Em seguida, os participantes completarão 5 semanas de Equitação Terapêutica em pequenos grupos (2 a 4 participantes) liderados por um instrutor de THR.
O grupo incluirá uma atividade montada de 45 minutos para aprender habilidades de equitação seguida por uma atividade de preparação e arreios de cavalos não montados de 15 minutos de acordo com o manual do THR.
Os participantes terão um cavalo designado e voluntários.
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Atividades de solo e equitação
Outros nomes:
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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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Aberrant Behavior Checklist-Community (ABC-C) - Baseline
Prazo: Baseline
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The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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Baseline
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Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
Prazo: End of Treatment
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The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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End of Treatment
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Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
Prazo: 6 months post intervention
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The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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6 months post intervention
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Social Responsiveness Scale™, Second Edition - End of Treatment
Prazo: End of Treatment
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
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End of Treatment
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Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
Prazo: 6 months post intervention
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
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6 months post intervention
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Emotion Dysregulation Inventory (EDI) - Baseline
Prazo: Baseline
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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Baseline
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Emotion Dysregulation Inventory (EDI) - End of Treatment
Prazo: End of Treatment
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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End of Treatment
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Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
Prazo: 6 months post intervention
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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6 months post intervention
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Systematic Analysis of Language Transcripts (SALT) - Baseline
Prazo: Baseline
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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Baseline
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Systematic Analysis of Language Transcripts (SALT) - End of Treatment
Prazo: End of Treatment
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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End of Treatment
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Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
Prazo: 6 months post treatment
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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6 months post treatment
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
Prazo: Baseline
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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Baseline
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
Prazo: End of Treatment
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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End of Treatment
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
Prazo: 6 months post intervention
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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6 months post intervention
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Social Responsiveness Scale™, Second Edition - Baseline
Prazo: Baseline
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors).
NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES.
The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES.
The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES.
The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
HIGHER SCORES ON THIS SUBSCALE.
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Baseline
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Salivary Cortisol - Baseline Baseline
Prazo: Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed separately.
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Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
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Salivary Cortisol - Mid-Point
Prazo: Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
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Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
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Salivary Cortisol - End of Treatment
Prazo: Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
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Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
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Heart Rate Variability - Baseline
Prazo: Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
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Heart Rate Variability - Mid-point
Prazo: Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
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Heart Rate Variability - End of Treatment
Prazo: Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
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Electrodermal Activity -- Baseline
Prazo: Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured during the intervention lesson.
Unit of measure is microsiemens.
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Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
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Electrodermal Activity - Mid-point
Prazo: Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
|
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
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Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
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Electrodermal Activity - End of Treatment
Prazo: Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
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Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus
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)
22 de dezembro de 2020
Conclusão Primária (Real)
22 de fevereiro de 2025
Conclusão do estudo (Real)
22 de fevereiro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
15 de outubro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de outubro de 2020
Primeira postagem (Real)
28 de outubro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 19-1962
- 1R01HD097693-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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
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 .