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)
Panoramica dello studio
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Sindh,
-
Karachi, Sindh,, Pakistan
- Dow University of Health Sciences
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
|
|
Nessun intervento: Control
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Positive and Negative syndrome scale (PANSS)
Lasso di tempo: 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)
Lasso di tempo: six months
|
Commonly apply to persons who care for relative or friends With a serious mental illness
|
six months
|
|
Carer Wel-Being & Support(CWS)
Lasso di tempo: six months
|
A questionnaire for carers of people with a mental Health problem
|
six months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Family Questionnaire(FQ)
Lasso di tempo: six months
|
Find out the problem of caregiver for relative or friends With a serious mental illness.
|
six months
|
|
Insight rating scale
Lasso di tempo: six months
|
Assesses Improvement in insight
|
six months
|
|
Calgary Depression Scale for Schizophrenia
Lasso di tempo: six months
|
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
|
six months
|
|
Short Explanatory Model Interview
Lasso di tempo: six months
|
used to elicit beliefs of mental illness
|
six months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Imran Chaudhry, MD, University of Manchester
- Investigatore principale: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
- Investigatore principale: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- Investigatore principale: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
- Investigatore principale: Raza Ur Rehman, FCPS, Dow University of Health Sciences
- Investigatore principale: Ajmal kazm, Pakistan Institute of Living and Learning
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FINT-PSY-02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Family intervention
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletatoDisturbo Oppositivo Provocatorio | Disturbo del comportamentoCanada
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... e altri collaboratoriCompletato
-
University of Alabama, TuscaloosaNational Institute of Nursing Research (NINR)CompletatoDolore | Cure palliative | Disturbi della ritenzione, cognitivi | Altre malattie cronicheStati Uniti
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletatoDisturbo d'ansiaCanada
-
University of ZurichETH Zurich (Switzerland)Reclutamento
-
Oregon Health and Science UniversityNational Institute of Mental Health (NIMH); University of Connecticut; University... e altri collaboratoriNon ancora reclutamento
-
China National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai HospitalReclutamentoIpertensione | Diabete mellito | Iperlipidemia | Dopo l'innesto di bypass coronarico | Post-PCICina
-
Federal University of Rio Grande do SulHospital Moinhos de VentoCompletatoIpertensioneBrasile
-
Superior UniversityAttivo, non reclutanteArtrosi al ginocchioPakistan
-
Michigan State UniversityCompletatoFatica | Obesità pediatrica | Dieta sana | Relazioni intergenerazionaliStati Uniti