A Multi-centric Trial to Evaluate the Efficacy of Electronic-Based Psychosocial Interventions on Future Suicide Risk Among Adolescent Suicide Attempters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Persistent Suicide Ideation
研究概览
简要总结
Our study is designed to study the efficacy of an Electronic based psycho-social intervention targeting healthy coping and problem solving skills to mitigate suicidal behaviour. This would integrate existing systems and bridge the gap in accessibility to care for suicidal behaviour.
详细描述
The investigators shall be performing the following Research Activities:
- Screening to establish eligibility for the study
- Obtaining Consent
- Baseline Assessment
- Randomisation
- Intervention
- Follow up and Assessments
Detailed description of each activity:
- Screening to establish eligibility for the study
- All adolescents with an episode of Deliberate Self Harm within the last one month: who present to the hospital in the Emergency / Casualty; Pediatric Out patient (OPD) / Pediatric in Patient (IPD), Medicine Out patient (OPD) / Medicine in Patient (IPD), Psychiatric in-patient/ Psychiatric Out-Patient units; shall be screened for the eligibility into the study.
- The adolescents who screen positive for Psychosis (as per the criteria for any psychotic disorder under ICD-10- F20 to F29) shall be excluded.
- The adolescents who screen positive for substance dependence (as per the M.I.N.I. KID 6.0) for any substance except nicotine shall be excluded from the study.
- Obtaining Consent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The rater will be blind to the group status of the participant.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adolescents who have attempted suicide within the last thirty days and presented to the study site
- •Between ages of 12-18 years
- •Participants of all gender will be included
- •Medically stable patients who have stable blood pressure, breathing rates without fever, and intact orientation to time, place, and person
排除标准
- •A current or a lifetime diagnosis of psychosis. We will confirm the same using a detailed clinical interview according to ICD-10 diagnostic guidelines.
- •A history of mental retardation and any neurological condition causing cognitive impairment.
- •A diagnosis of substance dependence as confirmed by M.I.N.I. KID 6.0 over the last six months. We will include those with tobacco dependence.
- •A diagnosis of serious medical illness like end-stage cancer, AIDS, less than a month following acute cardiovascular and cerebrovascular events.
研究组 & 干预措施
Electronic Based Psychosocial Intervention (EBPSI)
Electronic Based Psychosocial Intervention (EBPSI) described as video based telepsychiatry sessions targeted on brief intervention and coping skills; with a total of 5 sessions on days 10, 30, 45, 60 and 90 after baseline intervention.
干预措施: Electronic Based Psychosocial Intervention (EBPSI) (Behavioral)
Treatment as Usual
The Treatment as Usual (TAU) arm shall be a telephonic regular contact: with a total of 5 reminder calls on days 10, 30, 45, 60 and 90 after baseline intervention. The session shall include a reminder for the next planned follow up session and a general query for overall wellbeing.
干预措施: Electronic Based Psychosocial Intervention (EBPSI) (Behavioral)
结局指标
主要结局
Persistent Suicide Ideation
时间窗: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Change in intervention arm as compared to TAU on persistent suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS). the ideation ranges from 0-5 on this scale.
Suicide attempts
时间窗: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Change in intervention arm as compared to TAU on number of suicide attempts. Minimum attempts can be 0 and maximum can be infinity.
次要结局
- Acceptability of Intervention Measure (AIM)(At baseline and 1,3, 6 and 12 months after the baseline intervention.)
- Feasibility of Intervention Measure (FIM)(At baseline and 1,3, 6 and 12 months after the baseline intervention.)
- Coping Mechanism(At baseline and 1,3, 6 and 12 months after the baseline intervention.)
- Depression(At baseline and 1,3, 6 and 12 months after the baseline intervention.)
- Attribution Style(At baseline and 1,3, 6 and 12 months after the baseline intervention.)
研究者
Vishwajit Nimgaonkar, MD PhD
Professor
University of Pittsburgh