- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03012451
A Psychosocial Program Impact Evaluation in Jordan
13 de enero de 2021 actualizado por: Yale University
Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan.
The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will provide a robust evaluation of the Mercy Corps 'Advancing Adolescents, No Lost Generation' program that targets stress alleviation in refugee youth (12-18 years) with specific measures of psychosocial stress, biological stress, and cognitive function.
Tipo de estudio
Intervencionista
Inscripción (Actual)
817
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.
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 05611
- Yale University
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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
12 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Eligible and enrolled in Mercy Corps Advancing Adolescents program
- Syrian refugee and Jordanian host-community youth residing in 4 urban centers in northern Jordan
Exclusion Criteria:
- Not available for study recruitment (started sessions or deferred sessions before study start date).
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Advancing Adolescents
Received structured eight-week psychosocial sessions
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The "Advancing Adolescents" programme is a structured 8-week psychosocial intervention for adolescents in humanitarian crises, based on profound stress attunement processes.
It features three elements that are widely viewed as important to support youth adjustment in contexts of complex emergencies: (i) safety: establishment of a 'safe space' within the community as a base for activities and site of protection; (ii) support: facilitation of social support and self-expression; and (iii) structured activities: access to scheduled group activities.
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Sin intervención: Control
Controls wait-listed for the intervention, matched for age and urban residence
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Psychosocial Stress: Insecurity (Regional Measure)
Periodo de tiempo: 11 weeks
|
Insecurity was measured with The Human Insecurity (HI).
This tool was developed for use in the West Bank (Ziadni, Hammoudeh et al. 2011, Hamayel, Ghandour et al. 2014).
The 10-item scale is a 5-point Likert scale with scores expressed as percentages on a scale of 0-100.
The HI covers issues such as worries regarding inability to obtain daily life necessities, losing a source of income, fears about the future, and family safety.
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11 weeks
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Psychosocial stress: Distress (Regional Measure)
Periodo de tiempo: 11 weeks
|
Distress was measured with the Human Distress scale (Hamayel & Ghandour, 2014), developed for use with conflict-affected adolescents in the West Bank.
The 12-item scale is a 5-point Likert scale with scores expressed as percentages on a scale of 0-100.
Sample items include, "To what extent have you felt worried," "To what extent did you feel humiliated," and "To what extent did you feel angry."
Scores are presented as percentages (0-100%), with higher scores indicating greater distress.
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11 weeks
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Psychosocial Stress (International Measure)
Periodo de tiempo: 11 weeks
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Stress was measured using the Arabic version of the Perceived Stress Scale (Cohen, Karmarck, & Mermelstein, 1983), validated with a Jordanian sample (Almadi, Cathers, Hamdan Mansour, & Chow, 2012).
This 14-item, 5-point Likert scale measures perceived stress over the last month, with higher scores indicating greater stress.
Items include, "How often have you been upset because of something that happened unexpectedly?"
and "How often have you been able to control irritations in your life?" (reverse-scored) (1 = Never, 5 = Very often).
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11 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mental Health Difficulties: Regional Measure
Periodo de tiempo: 11 weeks
|
Mental health was assessed using the 21-item Arab Youth Mental Health questionnaire (Mahfoud et al., 2011; Mahkoul et al., 2011).
This measure includes questions such as, "During the last week I was upset", "During the last week I was bored and hated my life", and "During the last week, I was having a lot of headaches, stomach-aches, and nausea" (1 = Rarely, 3 = Always).
Higher scores indicate more symptoms of anxiety and depression.
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11 weeks
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Mental Health Difficulties: International Measure
Periodo de tiempo: 11 weeks
|
The Arabic version of the Strengths and Difficulties Questionnaire (SDQ), a brief screening tool for psychiatric difficulties (Alyahri & Goodman, 2006) was used.
The 20 items include emotional, conduct, and hyperactivity symptom scores (range 0-40).
We summed score of the Arabic version of the SDQ subscales relating to hyperactivity, emotional symptoms, conduct problems, and peer problems (Alyahri & Goodman, 2006).
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11 weeks
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Prosocial Behavior: International Measure
Periodo de tiempo: 11 weeks
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The Strengths and Difficulties Questionnaire (SDQ) Prosocial Score, which featured 5 items to assess prosociality was used.
Items include "I try to be nice to other people.
I care about their feelings" and "I am helpful if someone is hurt, upset, or feeling sick" (0 = Not true, 2 = Certainly true).
Higher scores indicate greater prosociality.
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11 weeks
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Resilience: Cross-cultural Measure
Periodo de tiempo: 11 weeks
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Resilience was measured using the CYRM-28 (Liebenberg et al., 2012; Ungar & Liebenberg, 2011), which had been translated and culturally grounded for use into Arabic.
Responses ranged from 1 ("Not at all") to 5 ("A lot"), with higher scores indicating greater resilience.
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11 weeks
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Biological Stress: Cortisol
Periodo de tiempo: 11 weeks
|
Cortisol was obtained from immunoassays of scalp hair cortisol that provide useful measures of the altered activity of the hypothalamic-pituitary-adrenal axis.
Scalp hair is collected non-invasively (~100 strands, 0.5 cm area).
This measure indicates chronic stress over the last month, and examined per individual for pre/post intervention levels.
These analyses are being undertaken by Professor van Uum at Western Ontario University.
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11 weeks
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Biological Stress: Cell-mediated Immune Function
Periodo de tiempo: 11 weeks
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Cell-mediated immune function was measured in field settings, using systemic suppression of immune function in response to chronic stress is measured via immunoassays for Epstein Barr Virus antibodies, in conjunction with C-Reactive Protein, from dried blood spots collected from pricking the finger with a sterile disposable lancet.
Three drops of blood on filter paper are dried at room temperature, then frozen until lab assay.
This measure reflects compromised immune response due to psychosocial stress over the past week, and examined per individual for pre/post intervention levels.
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11 weeks
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Cognitive function
Periodo de tiempo: 11 weeks
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Cognitive function was assessed using tablet-based cognitive skill tasks, testing hippocampal function (long term memory) and prefrontal executive function.
Children play short games (1-4 min each) during which they press the tablet in response to geometric shapes.
Responses during game play are recorded and used to measure cognitive function.
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11 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Posttraumatic stress symptoms
Periodo de tiempo: 11 weeks
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The Arabic version of the Child Revised Impact of Events Scale (CRIES-8, 4-point scale) was implemented to assess posttraumatic stress symptoms.
Analysis will be on dimensional scores, noting that CRIES >17 points is predictive of symptoms of posttraumatic stress disorder (http://www.childrenandwar.org).
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11 weeks
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Genetic markers of trauma and/or stress
Periodo de tiempo: 11 weeks
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Genetic and epigenetic analyses in DNA will be undertaken from cheek swab samples to investigate the biological signatures of altered expressions of trauma and/or psychosocial stress.
Whole-genome amplification of the extracted DNA will be used to generate maximum genetic data from the samples.
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11 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: catherine panter-brick, PhD, Yale University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de abril de 2015
Finalización primaria (Actual)
1 de septiembre de 2016
Finalización del estudio (Actual)
1 de abril de 2017
Fechas de registro del estudio
Enviado por primera vez
21 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
4 de enero de 2017
Publicado por primera vez (Estimar)
6 de enero de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
13 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1502015359
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
We are sharing the anonymized dataset with project collaborators, but only with other researchers upon explicit request.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .