Exploratory RCT of Culturally Adapted Manual Assisted Problem Solving Training (C-MAP) for Self Harm in Females of South Asian Family Origin
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Suicidal Ideation (Beck scale for suicidal ideation)
Study Overview
Brief Summary
Aim of the study is to adapt and develop a culturally appropriate psychological intervention and to pilot test it's feasibility, and acceptability for the adult South Asian females presenting to general hospital emergency department following self-harm. Primary hypothesis for the study is to determine whether a brief psychological intervention compared with treatment as usual for self-harm results in decreased hopelessness and suicidal ideation. Further to this to collect necessary information on recruitment, the assessment instruments, effect size, the optimal delivery and acceptability of the intervention in preparation for a definitive RCT using repetition of self harm and cost effectiveness as the primary outcome measures.
Detailed Description
Secondary Hypothesis for the study is to compare the impact of the intervention and treatment as usual on patients' satisfaction with care, resolution of interpersonal and family problems and attributions to fully understand the mechanism of action of the intervention.
Background and Significance:
Most economically developed nations are multi-ethnic. If current demographic trends continue societies will become more ethnically diverse. UK censuses revealed that the proportion of the UK population belonging to a non-white minority ethnic group increased by 53% between 1991 and 2001, from 3 million to 4.6 million (or 7.9% of the UK population). Half of the total ethnic minority population is of south Asian family origin (UK census 2001).
Suicide, a self-directed violence, is a global public health problem. According to a recent report from the World Health Organization, world wide, suicide claimed the lives of an estimated 815,000 people in the year 2000, for an over all age-adjusted rate of 14.5 per 100,000 (WHO, 2002). In the United Kingdom, suicide is the second most common cause of death in people aged 15-24 (Hawton et al, 1998).
Prevention of suicide is now included in health policy initiatives in several countries and reduction in suicidal behavior, both fatal and non-fatal, is part of the Health for All targets of the World Health Organization (WHO, 1992). Prevention of suicide is also a priority for health services in England (Department of health, 1999a,b, 2002).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All females of self ascribe south Asian family origin presenting to an emergency department of the proposed study centers after an episode of self-harm.
- •By self harm we mean self inflicted injury, and/or ingestion of drugs in excess of the recommended therapeutic dose, with some intention of ending one's life (Vajda and Steinbeck 2000).
- •Age: 16 - 65 years
- •Resident in the trial site catchment area
Exclusion Criteria
- •Participants will not be excluded based on limited knowledge of English.
- •Temporary resident unlikely to be available for follow up.
- •ICD 10 diagnosis organic (F.0), of alcohol and drug dependence (F.1x.2) Schizophrenia (F.2) or Bipolar Affective Disorder (F.31) because these patients require a different treatment approach.
- •Psychiatric admission required after deliberate self-harm.
Outcomes
Primary Outcomes
Suicidal Ideation (Beck scale for suicidal ideation)
Time Frame: 6 months
Hopelessness (Beck hopelessness scale)
Time Frame: 6 months
Time to self-reported repetition of self harm (estimate for RCT)
Time Frame: 6 months
Secondary Outcomes
- Depressive symptoms assessed by Beck Depression Inventory(6 months)