- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00073619
Preventing Anxiety Disorders in Urban Youth
Community Violence and Youth: Preventing Anxiety Disorders
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Community violence is a major public health problem in low-income, urban communities. The mental health impact of living in a violent community is significant, particularly for children. Community violence exposure is associated with various symptoms of anxiety. Unfortunately, little research on the prevention of community-related anxiety in youth has been conducted. This study involves a school-based prevention and cognitive behavioral therapy program that will involve predominantly African American children who live in urban areas and are at risk for developing anxiety disorders.
Children in this study will be randomly assigned to either an anxiety prevention and early intervention group or a nonintervention group for approximately 3 months. Child, parent, and teacher assessments of anxiety symptoms will be made at the end of the study and at a 6-month follow-up visit.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins Bloomberg School of Public Health
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Mild exposure to community violence
- Mild to moderate anxiety symptoms or disorders
- Attending public elementary school in an urban area
- In 3rd to 5th grades
Exclusion Criteria:
- Diagnostic and Statistical Manual-IV disruptive behavior disorder
- Too many or too few anxiety symptoms
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cognitive-behavioral group therapy
School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence.
Participants received the weekly intervention and rewards for participating in the assessments.
|
School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence.
Participants received the weekly intervention and rewards for participating in the assessments.
|
|
Sin intervención: Non-intervention Comparison
Provide no active intervention to the comparison group, although assess the children at the same assessment points as the experimental group.
Participants in the control arm were told they were FRIENDS Program participants.They received rewards for participating in the assessments.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Revised Children's Manifest Anxiety Scale
Periodo de tiempo: Past month
|
Revised Children's Manifest Anxiety Scale (RCMAS; Reynolds & Richmond, 1997), a self-report measure of the level and nature of anxiety in children and adolescents.
It is a 37-item questionnaire in which students agree or disagree to statements pertaining to how some people think or feel about themselves, assessing different ways anxiety is manifested.
A higher score indicates more anxiety and distress.
The RCMAS has good internal consistency (alpha = 0.83) and test-retest reliability (r = 0.68).
In the FRIENDS study, Total RCMAS reliability was alpha = 0.83 at baseline and alpha = 0.84 at post-assessment.
|
Past month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Wechsler Individual Achievement Test-Screener
Periodo de tiempo: Past year
|
Academic achievement was assessed using the Wechsler Individual Achievement Test-Screener (WIAT-Screener; Psychological Corporation, 1992), which consists of three subtests of the comprehensive WIAT battery (i.e., Basic Reading, Mathematics Reasoning, Spelling).
It assesses basic academic skills; permits the calculation of age- and grade-based standard scores; was standardized using a large representative sample; is widely used; and has demonstrated reliability and validity with little evidence of practice effects (Psychological Corporation, 1992).
|
Past year
|
|
Multicultural Events Schedule for Adolescents
Periodo de tiempo: Past year
|
Adverse life events were assessed using the Multicultural Events Schedule for Adolescents (MESA; Gonzales, Gunnoe, Samaniego, & Jackson, 1995), developed to assess major and minor life events specific to an urban multiethnic population (Gonzales et al., 1995).
It was normed on African American, European American, and English- and Spanish-speaking Mexican Americans.
The MESA includes 84 items in which a student responds yes or no to each life events over the past year.
A Total life events score is based on the number of events endorsed, with a higher score indicating more adverse life events and hassles.
The MESA has adequate concurrent validity and test-retest reliability (Gonzales et al., 1995).
In the FRIENDS project, the MESA Total score alpha = .89
at baseline, and alpha = .95
at the post-assessment.
|
Past year
|
|
Children's Report of Exposure to Violence
Periodo de tiempo: Past year and Lifetime
|
Children's Report of Exposure to Violence (CREV; Cooley, Turner, & Beidel, 1995).
The CREV is a widely used self-report questionnaire developed to assess children's lifetime exposure to community violence.
It has good two-week test-retest reliability (r = 0.75), internal consistency (overall alpha = .78),
and construct validity (Cooley et al., 1995).
Twenty-nine scored CREV items are rated on a 5-point Likert scale, ranging from 0-''no, never'' to 4-''everyday,'' to indicate the frequency of exposure to community violence via four modes (i.e., media, hearsay, witness, victimization).
Types of violent situations include being chased or threatened, beaten up, robbed or mugged, shot, stabbed, or killed.
Higher scores indicate more perceived exposure.
A past-year version of the CREV was developed and administered at the post-assessment evaluation.
Cronbach's alpha for the lifetime CREV Total score was .88 at baseline and .90 for the past-year version.
|
Past year and Lifetime
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michele R Cooley, Ph.D., Johns Hopkins Bloomberg School of Public Health
Publicaciones y enlaces útiles
Publicaciones Generales
- Lambert SF, Cooley MR, Campbell KD, Benoit MZ, Stansbury R. Assessing anxiety sensitivity in inner-city African American children: psychometric properties of the childhood anxiety sensitivity index. J Clin Child Adolesc Psychol. 2004 Jun;33(2):248-59. doi: 10.1207/s15374424jccp3302_5.
- Cooley MR, Boyce CA. An introduction to assessing anxiety in child and adolescent multiethnic populations: challenges and opportunities for enhancing knowledge and practice. J Clin Child Adolesc Psychol. 2004 Jun;33(2):210-5. doi: 10.1207/s15374424jccp3302_1.
- Cooley, M., Boyd, R.C., & Grados, J.J. (2004). Feasibility of an anxiety preventive intervention for community violence exposed children. The Journal of Primary Prevention, 25(1), 105-123.
- Cooley-Strickland MR, Griffin RS, Darney D, Otte K, Ko J. Urban African American youth exposed to community violence: a school-based anxiety preventive intervention efficacy study. J Prev Interv Community. 2011;39(2):149-66. doi: 10.1080/10852352.2011.556573.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R21MH063143 (Subvención/contrato del NIH de EE. UU.)
- DSIR CT-P (Otro identificador: NIMH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. .