Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
26 de agosto de 2026 actualizado por: Shahar Almog, Florida Atlantic University
The goal of this pilot clinical trial is to examine feasibility, acceptability, and direction of effect of a dyadic (child and parent) trauma-informed yoga intervention on stress symptoms and sleep in young children (age 3-6) after war. The main questions it aims to answer are:
- Is the intervention feasible and liked by the participants?
- Does the child-parent yoga intervention reduce the child's stress symptoms and improve their sleep?
- Does the child-parent yoga intervention improve the child-parent relationship?
Participants (child-parent dyads) will:
- Children and parents will participate together in 8 weekly group yoga sessions.
- Children and parents will engage together in a short daily at-home practice before bedtime.
- Parents will complete online surveys before and after the 8-week program, and at one-month follow-up.
- Parents will complete a daily practice-sleep log.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
66
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Shahar Almog, PhD
- Número de teléfono: +1 (561) 2973461
- Correo electrónico: salmog@fau.edu
Copia de seguridad de contactos de estudio
- Nombre: Noga Tsur, PhD
- Correo electrónico: nogatsur@tauex.tau.ac.il
Ubicaciones de estudio
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Florida
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Boca Raton, Florida, Estados Unidos, 33431
- Florida Atlantic University
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Tel Aviv, Israel
- Tel Aviv University
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Contacto:
- Noga Tsur, PhD
- Número de teléfono: 0000000000
- Correo electrónico: nogatsur@tauex.tau.ac.il
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Investigador principal:
- Noga Tsur, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
Children: Age 3-6. Per the parent's report, the child exhibits at least one stress-related symptom.
Parents: Preferably, the same parent can attend all group sessions. Having internet access at home to complete online surveys.
Exclusion Criteria:
Children: Any physical disability that prevents participating safely in yoga sessions.
Parents: Self-reported pregnancy. Any physical disability that prevents participating safely in gentle yoga sessions.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Dyadic (Child-Parent) Yoga
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Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child's Stress Symptoms
Periodo de tiempo: 8 weeks
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Presence and severity of stress symptoms will be assessed (parent-reported) using the Young Child PTSD Checklist (YCPC).
The 30-item scale yields a sum score ranging from 0 to 120, with higher scores indicating more severe stress symptoms.
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8 weeks
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Child's Sleep Quality
Periodo de tiempo: 8 weeks
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The child's sleep quality will be assessed (parent-reported) using the Children's Sleep Habits Questionnaire Abbreviated (CSHQ).
The 22-item scale yields a sum score ranging from 0 to 88, with higher scores indicating more severe sleep problems.
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8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child-Parent Relationship: Closeness
Periodo de tiempo: 8 weeks
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The quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Closeness subscale.
The 7-item subscale yields a sum score of 7 to 35, with higher scores indicating greater closeness.
Higher closeness scores reflect better relationship between the child and the parent.
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8 weeks
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Child-Parent Relationship: Conflict
Periodo de tiempo: 8 weeks
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The quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Conflict subscale.
The 8-item subscale yields a sum score of 8 to 40, with higher scores indicating greater conflict.
Lower conflict scores reflect better relationship between the child and the parent.
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8 weeks
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Parent's Stress Symptoms
Periodo de tiempo: 8 weeks
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Presence and severity of post-traumatic stress symptoms will be assessed (self-reported) using the PCL-5 scale.
The 20-item scale yields a sum score ranging from 0 to 80, with higher scores indicating more severe post-traumatic stress symptoms.
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8 weeks
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Parent's Sleep Quality
Periodo de tiempo: 8 weeks
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The parent's sleep quality will be assessed (self-reported) using the Sleep Disturbance PROMIS SF 8b.
The 8-item scale yields a sum score ranging from 8 to 40, with higher scores indicating more severe sleep problems.
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8 weeks
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Parental Self-Efficacy
Periodo de tiempo: 8 weeks
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The parent's self-confidence in their ability to handle their child's behavior problems will be assessed (self-reported) by the Brief Parental Self-Efficacy Scale.
The 5-item scale yields a sum score ranging from 5 to 20, with higher scores indicating greater self-confidence.
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8 weeks
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Child's Pain Severity
Periodo de tiempo: 8 weeks
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If the child experiences pain, pain severity will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI).
Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.
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8 weeks
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Child's Pain Interference
Periodo de tiempo: 8 weeks
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If the child experiences pain, pain interference with routine activities will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI).
The level of how much the pain interferes with routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.
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8 weeks
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Parent's Pain Severity
Periodo de tiempo: 8 weeks
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If the parent experiences pain, pain severity will be assessed (self-reported) using one item from the Brief Pain Inventory (BPI).
Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.
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8 weeks
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Parent's Pain Interference
Periodo de tiempo: 8 weeks
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If the parent experiences pain, pain interference will be assessed (self-reported) using two items from the Brief Pain Inventory (BPI).
The level of how much the pain interferes with (a) enjoyment in life and with (b) routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.
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8 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility: Recruitment
Periodo de tiempo: Recruitment period, from initiation until the start day of the intervention
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Recruitment will be calculated as the proportion of enrolled participants to interested individuals during the recruitment period.
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Recruitment period, from initiation until the start day of the intervention
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Feasibility: Intervention Retention
Periodo de tiempo: 8 weeks
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Retention will be calculated as the proportion of participants who completed the intervention to participants who gave their consent to participate.
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8 weeks
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Feasibility: Intervention Adherence
Periodo de tiempo: 8 weeks
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Percentage of participants completing at least 75% of the group sessions AND at least 4 at-home practices per week.
Group session attendance will be monitored by the research team.
At-home practice will be self-reported via a daily practice log.
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8 weeks
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Acceptability: Liking
Periodo de tiempo: 8 weeks
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Parents will be asked if they liked the intervention on a scale of 0 to 10, with higher ratings indicating greater liking and better acceptability of the intervention among parents.
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8 weeks
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Acceptability: Recommending
Periodo de tiempo: 8 weeks
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Parents will be asked about the likelihood that they would recommend the program to others, rated from 0 to 100%, with higher ratings indicating a greater likelihood of recommending the intervention and better acceptability of the intervention among parents.
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8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shahar Almog, PhD, Florida Atlantic University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de octubre de 2026
Finalización primaria (Estimado)
10 de febrero de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB2602072
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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