- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02167347
Culturally Adapted Family Intervention For Psychosis
Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being & Support(CWS)
Descripción general del estudio
Descripción detallada
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
- To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
- To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
- To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress
the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sindh,
-
Karachi, Sindh,, Pakistán
- Dow University of Health Sciences
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
- Individuals aged between 18-65.
- Resident of Karachi.
- Participant is able to give informed written consent.
Exclusion Criteria:
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Family Intervention
Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis
|
This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
Otros nombres:
|
Sin intervención: Control
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Positive and Negative syndrome scale (PANSS)
Periodo de tiempo: six months
|
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
|
six months
|
Experience of Care-giving inventory(ECI)
Periodo de tiempo: six months
|
Commonly apply to persons who care for relative or friends With a serious mental illness
|
six months
|
Carer Wel-Being & Support(CWS)
Periodo de tiempo: six months
|
A questionnaire for carers of people with a mental Health problem
|
six months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Family Questionnaire(FQ)
Periodo de tiempo: six months
|
Find out the problem of caregiver for relative or friends With a serious mental illness.
|
six months
|
Insight rating scale
Periodo de tiempo: six months
|
Assesses Improvement in insight
|
six months
|
Calgary Depression Scale for Schizophrenia
Periodo de tiempo: six months
|
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
|
six months
|
Short Explanatory Model Interview
Periodo de tiempo: six months
|
used to elicit beliefs of mental illness
|
six months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Imran Chaudhry, MD, University of Manchester
- Investigador principal: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
- Investigador principal: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- Investigador principal: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
- Investigador principal: Raza Ur Rehman, FCPS, Dow University of Health Sciences
- Investigador principal: Ajmal kazm, Pakistan Institute of Living and Learning
Publicaciones y enlaces útiles
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
- FINT-PSY-02
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. .
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