Clinical trial NCT04338464: The Roshni Project - Developing a Psychosocial Intervention
Official title: The Roshni Project Phase 3: Developing a Culturally Driven Approach to Enhancing the Mental Well-being of Young South Asian Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood Disorders
Keywords: Cultural Relevance
Cultural Adaptation
South Asian
Gender
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The mental health sector is being called upon to develop and implement interventions for youth that attend to gender, age and cultural diversity (Mental Health Commission of Canada, 2016). The proposed project outlines the development and feasibility testing of a culturally driven transdiagnostic psychosocial intervention for South Asian women aged 16-24 years. We will recruit 30 participants to complete the 12 week psychosocial intervention. Pre, midpoint and post evaluations will be completed to asses change in mental health, self esteem and values, and also qualitative feedback on participant experiences of the intervention.


Eligibility criteria: Inclusion criteria:

* aged 16-24 years
* identify as a woman
* ancestry connected to India, Pakistan, Bangladesh and Sri Lanka
* formal diagnosis of mood or anxiety disorder
* completed high-school in Canada
* reside in the Greater Toronto Area
* speak conversational English

Exclusion criteria:

• individuals with developmental disabilities and serious mental illness e.g. schizophrenia spectrum, bipolar and personality disorders.

Primary outcomes:
measure: Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995)
timeFrame: Change from baseline depression, anxiety and stress at 12 weeks
Secondary outcomes:
measure: Emotion Regulation Questionnaire (Gross & John, 2003)
timeFrame: Change from baseline emotion regulation at 12 weeks
Other outcomes:
measure: Rosenberg Self Esteem Scale (Rosenberg, 1965)
timeFrame: Change from baseline self esteem at 12 weeks
measure: Connor-Davidson Resilience Scale (Campbell Sills & Stein, 2007)
timeFrame: Change from baseline resilience at 12 weeks
measure: Culture and Identity Schedule (Bhugra et al., 1999)
timeFrame: Change from baseline cultural identity at 12 weeks
measure: Cultural Values Conflict Scale for South Asian women (Inman et al., 2001)
timeFrame: Change from baseline cultural values conflict at 12 weeks
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF) (Skevington, Lofty, O'Connell, 2004)
timeFrame: Change from baseline quality of life at 12 weeks
measure: Working Alliance Inventory (Horvath & Greenberg, 1989)
timeFrame: 12 weeks
measure: Demographics
timeFrame: Baseline
measure: Service Use & Access
timeFrame: Baseline
measure: Service Use & Access
timeFrame: 6 weeks
measure: Service Use & Access
timeFrame: 12 weeks
measure: Qualitative Interviews
timeFrame: 6 weeks
measure: Qualitative Interviews
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Gursharan Virdee, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: