Teen Recovery Through Inspiration, Support, and Empowerment (RISE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Suicidal Ideation as measured by C-SSRS at 2 weeks from baseline
研究概览
简要总结
The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.
The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS).
Participants will be assigned to either Cohort A or B for 8 weeks.
Cohort A will be the intervention group with online access to an RES, TP, and PSS.
- Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4.
- Week 5 and 7: one-one meetings with PSS and TP for education and support.
- Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8.
Cohort B will be the SOC group with no PSS, TP, or RES.
- Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4.
- Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8.
Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
详细描述
Purpose:
- This is a pilot study to test the effectiveness of a novel intervention aimed at reducing the incidences of suicidality, depression, anxiety, re-hospitalization rates, and improving mental health recovery by utilizing outpatient services, and medication adherence for high school teenagers ages 15-18, with mental health conditions verses the standard of care (SOC) at discharge which only provides a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.
- The intervention will use trained peers (TP), peer support specialists (PSS), and an online recovery education and support (RES) platform aimed at improving knowledge, awareness, and utilization of recovery and wellness programs for those patients recently discharged from an acute psychiatric treatment facility.
Objectives:
- Implement a program of mental health recovery education and support through virtual one-on-one and small group meetings with a TP and PSS for individuals recently discharged from an acute care psychiatric facility to determine the effectiveness of: Reduction of suicidality, depression, anxiety, re-hospitalization rate AND Improvement in mental health recovery by participating in outpatient services, and medication adherence.
- Determine if peer-led interventions improve knowledge, awareness, and utilization of recovery and wellness programs and support.
Endpoints:
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
- None
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
- •recently discharged from inpatient care or from emergency department
- •men and women ages 15-18 years old
排除标准
- •- primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)
研究组 & 干预措施
Cohort A: Intervention Group with PSS, TP, and RES
Virtual one on one meetings peer support specialist (PSS), trained peer (TP) using recovery education and support program (RES). Group meetings with PSS, TP, and other participants. Qualitative and quantitative assessments.
干预措施: Peer Support Services Recovery (Behavioral)
Cohort B: Standard of Care
Scheduled telephone call visit with a member of the research team. Qualitative and quantitative assessments.
结局指标
主要结局
Change in Suicidal Ideation as measured by C-SSRS at 2 weeks from baseline
时间窗: Baseline, 2 weeks
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 2 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Change in Suicidal Ideation as measured by C-SSRS at 4 weeks from baseline
时间窗: Baseline, 4 weeks
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 4 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Change in Suicidal Ideation as measured by C-SSRS at 6 weeks from baseline
时间窗: Baseline, 6 weeks
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 6 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
Change in Suicidal Ideation as measured by C-SSRS at 8 weeks from baseline
时间窗: Baseline, 8 weeks
Change in suicidal ideation is measured by Columbia Suicide Severity Rating Scale (C-SSRS) at 8 weeks from baseline using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal behavior from a minimum of 0 (corresponding to no suicidal behavior) to a maximum of 5 (representing active suicidal behavior).
次要结局
- Changes in symptoms associated with depression as measured by PHQ-9 at 2 weeks(Baseline, 2 weeks)
- Changes in symptoms associated with anxiety as measured by GAD 7 at 2 weeks(Baseline, 2 weeks)
- Changes in symptoms associated with anxiety as measured by GAD 7 at 4 weeks(Baseline, 4 weeks)
- Changes in symptoms associated with anxiety as measured by GAD 7 at 6 weeks(Baseline, 6 weeks)
- Changes in symptoms associated with anxiety as measured by GAD 7 at 8 weeks(Baseline, 8 weeks)
- Changes in symptoms associated with depression as measured by PHQ-9 at 4 weeks(Baseline, 4 weeks)
- Changes in symptoms associated with depression as measured by PHQ-9 at 6 weeks(Baseline, 6 weeks)
- Changes in symptoms associated with depression as measured by PHQ-9 at 8 weeks(Baseline, 8 weeks)
研究者
Joseph Guillory
Principal Investigator
University of Texas Southwestern Medical Center