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)
Studieoversikt
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Sindh,
-
Karachi, Sindh,, Pakistan
- Dow University of Health Sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
|
|
Ingen inngripen: Control
Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Positive and Negative syndrome scale (PANSS)
Tidsramme: 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)
Tidsramme: six months
|
Commonly apply to persons who care for relative or friends With a serious mental illness
|
six months
|
|
Carer Wel-Being & Support(CWS)
Tidsramme: six months
|
A questionnaire for carers of people with a mental Health problem
|
six months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Family Questionnaire(FQ)
Tidsramme: six months
|
Find out the problem of caregiver for relative or friends With a serious mental illness.
|
six months
|
|
Insight rating scale
Tidsramme: six months
|
Assesses Improvement in insight
|
six months
|
|
Calgary Depression Scale for Schizophrenia
Tidsramme: six months
|
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
|
six months
|
|
Short Explanatory Model Interview
Tidsramme: six months
|
used to elicit beliefs of mental illness
|
six months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Imran Chaudhry, MD, University of Manchester
- Hovedetterforsker: Nusrat Husain, MD, Pakistan Institute of Learning and Living, University of Manchester
- Hovedetterforsker: Farooq Naeem, MRCPsych, Pakistan Institute of Learning and Living, University of Southampton
- Hovedetterforsker: Munir Hamirani, FCPS, Abbasi Shaheed Hospital
- Hovedetterforsker: Raza Ur Rehman, FCPS, Dow University of Health Sciences
- Hovedetterforsker: Ajmal kazm, Pakistan Institute of Living and Learning
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FINT-PSY-02
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