A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
23 de abril de 2016 actualizado por: Zahra Shahrivar, Tehran University of Medical Sciences
A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study
The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for children with anxiety disorders (AD) is undeniable.
However, most children with AD have limited access to CBT.
There is some controversial evidence on group CBT in AD involving families in treatment of their children and a published article on efficacy of a parent only group CBT for these children.
Considering these data, the investigators hypothesized that teaching anxiety-fighting skills to parents of children with AD would diminish anxiety symptoms of both parents and children and improve family relational functioning.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
All children and their parents were interviewed using K-SADS-PL-Persian Version, a semi-structured diagnostic interview to confirm the diagnoses and assess possible comorbidities.
All diagnostic assessments were conducted by a fellowship of child and adolescent psychiatry.
Following assessment, once the participants reached twenty members, they were invited to complete child and parent self-report measures.
The level of child functioning and family relationship functioning were also evaluated.
Then they were randomly allocated to either parent training (N=20) or a 6 week wait-list (N=22) groups.
During 2 weeks after treatment the assessments were repeated and satisfaction ratings were collected for the intervention group.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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
-
-
-
Tehran, Irán (República Islámica de, 13333
- Rouzbeh Hospital
-
-
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
6 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
- age 6 to 12 years,
- receiving one of selective serotonin reuptake inhibitor (SSRI) medicine at the stable dose for at least 8 weeks before baseline assessments and during the study,
- at least one parent willing to participate and give written consent.
Exclusion Criteria:
- diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
- there was a change in drug regime during the study period,
- if parents missed more than 2 of 6 sessions of treatment.
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 |
|---|---|
|
Comparador activo: A parent only group CBT
There was a Group cognitive behavioral intervention -based on parent training component of "FRIENDS" program- for parents of children with anxiety disorders who were allocated to intervention group.
|
A Group cognitive behavioral intervention _based on parent training component of FRIENDS program_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions.
Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.
|
|
Sin intervención: Waiting list group
Parents of children with anxiety disorders who met the inclusion criteria and gave written informed consent and were allocated to wait list group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Revised Children's Manifest Anxiety (RCMA)
Periodo de tiempo: up to 30 minutes
|
This self report questionnaire consists of 28 items assessing a child's chronic or trait anxiety and 9 items assessing social desirability or potential lying.
The RCMA has achieved a high internal consistency and moderate test-retest reliability.
|
up to 30 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Children's Depression Inventory (CDI)
Periodo de tiempo: 20 minutes
|
This self report inventory has 27 items related to the cognitive, affective and behavioral signs of depression.
The scale has high internal consistency and moderate test-retest reliability
|
20 minutes
|
|
Depression-Anxiety-Stress Scale (DASS)
Periodo de tiempo: 20 minutes
|
This is a 42 item self-report instrument designed to measure the negative emotional states of depression, anxiety and stress.
The DASS was shown to possess satisfactory psychometric properties.45-47
Parents completed this scale about their own negative emotional states
|
20 minutes
|
|
Children Global Assessment Scale (CGAS)
Periodo de tiempo: 15 minutes
|
This Scale was developed to be a more child-specific measure of functioning.
This measure is currently used in diagnosis, treatment, and evaluation of children's mental health problems to determine eligibility to receive mental health services and document treatment outcome status
|
15 minutes
|
|
Assessment of Consumer Satisfaction
Periodo de tiempo: 25 minutes
|
Post treatment, parents in the intervention group completed a satisfaction questionnaire to rate how useful the program was in controlling their own anxiety, in managing their child anxious behavior, in improving family relations, the likelihood they would attend the treatment program again if needed, and if they would recommend the program to others on a 1 (not recommend) to 7 (highly recommend) likert scale
|
25 minutes
|
|
Strengths and Difficulties Questionnaire (SDQ) Home Version
Periodo de tiempo: [Time Frame: 30 minutes]
|
This questionnaire is a parent report of psychopathology in children and adolescents.
The scale consists of 25 items which generates five subscale scores (Emotional Symptoms, Conduct Problems, Inattention/Hyperactivity, Peer Problems and Prosocial Behavior) and a Total Difficulties Score.
We used the SDQ Emotional Symptoms Scale (SDQ-Em) as a parent measure of child anxiety.
SDQ has adequate internal consistency (α=0.37) and good test-retest reliability (r=0.62).42-44
The validity and reliability of SDQ has been confirmed in community samples of Iranian children and adolescents
|
[Time Frame: 30 minutes]
|
|
Global Relational Assessment of Functioning (GRAF)
Periodo de tiempo: [Time Frame: 15 minutes]
|
It provides a measure of the quality of functioning based on a review of three major areas: problem-solving, organization, and the emotional atmosphere.
Available psychometric evidence suggests that clinician and even non clinician raters can achieve good to excellent reliability with only minimal training.
The validity of the GRAF is supported by expected correlations with other measures of family and couple distress and functioning
|
[Time Frame: 15 minutes]
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Zahra Shahrivar, MD, Tehran University of Medical Sciences
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 julio de 2008
Finalización primaria (Actual)
1 de mayo de 2009
Finalización del estudio (Actual)
1 de julio de 2009
Fechas de registro del estudio
Enviado por primera vez
16 de enero de 2012
Primero enviado que cumplió con los criterios de control de calidad
19 de enero de 2012
Publicado por primera vez (Estimar)
20 de enero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
23 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Parent CBT for Anxiety
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. .