FASE-family and social engagement model for prevention and management of self harm behavior-a study protocol for cluster randomized control trial in India

BACKGROUND: Suicide is a substantial public health concern for countries worldwide. Effective preventive and curative interventions for self-harm behavior (SHB) are imperative for nations with an alarmingly high rate of suicide and self-harm behaviors. The intervention protocol named FASE (Family and Social Engagement) consists of comprehensive assessment, Attachment-Based Family Therapy (ABFT), and community linkages for people presenting with suicide or self-harm in emergency departments of tertiary hospitals. METHODS: This article reports the design and protocol for a cluster randomized control trial for suicide prevention and management. After the developed intervention is pilot tested in a tertiary hospital in Kerala, the intervention will be scaled up to be implemented in various tertiary hospitals in Kerala. Each hospital emergency department will be considered a cluster, and these clusters will be randomized to the intervention group and control group in a 1:1 ratio. The eligible people from the intervention clusters will undergo a baseline assessment, a structured moderate intense intervention with twelve sessions spread across 6 months by the trained social workers supervised by the Mental health team, and a follow-up assessment at the end. Participants will be recruited after obtaining consent and explaining the study. The primary outcome includes suicidality measured by the Depressive Symptom Inventory-Suicidality Subscale (DSI-SS), Depression, Anxiety and Stress Scale (DASS), MOS Social Support Survey, and Brief resilience scale (BRS). DISCUSSION: Knowledge generated from this trial can significantly affect new programmatic policy and clinical guidelines that will improve the reduction of suicide rates in the country. TRIAL REGISTRATION: Prospectively registered in Clinical Trial Registry India (ICMR-NIMS) on 18/10/2021 (ref number- REF/2021/10/048264).