ETUDES Center- Text2Connect - Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Engagement With Intervention: Drop Out Rate
研究概览
简要总结
Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.
详细描述
To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
Assignment of Interventions:
The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.
Hypothesis:
Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant engaged in treatment at CC Waterdam, STAR or CABS clinic
- •Participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report
- •At least 18 years of age
- •Recently graduated high school
- •Planning to attend college or higher education program within 6 weeks
- •Own a text-capable phone
- •Be willing and able to provide informed consent
排除标准
- •Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect
- •Under the age of 18yo
- •Non-English speakers
结局指标
主要结局
Engagement With Intervention: Drop Out Rate
时间窗: Over 3 months after baseline
Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as \>70% response rate. Participants are considered "dropped out" if they requested to be removed from the T2C intervention and all texts to be stopped.
Usability & Satisfaction-CSQ
时间窗: 3 month follow up timepoint
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Client Satisfaction Questionnaire (CSQ8). 8 items are scored on a likert scale of 1 to 4. Item 1 (reverse scored): scale 1(excellent)-4 (poor); Item 2: 1(definitely not)-4(definitely); item 3(reverse scored): 1(none of needs met)-4(all needs met); item 4: 1(definitely not)-4(definitely); item 5: 1(quite dissatisfied)-4(very satisfied); item 6(reverse scored): 1(made things worse)-4(helped a great deal); item 7 (reverse scored): 1(quite dissatisfied)-4(very satisfied); item 8: 1(definitely not)-4(definitely). Higher scores=higher satisfaction (score sum range is 8-32).
General Self-Efficacy
时间窗: 3 month Timepoint
Mental health self-efficacy will be assessed via the General Self-Efficacy Scale (GSE), as the primary outcome of Text2Connect Phase 2. The GSE contains 10 items scored on a 4-point Likert Scale, with scores ranging from 10-40. Higher scores indicate greater self-efficacy.
Engagement With Intervention: Web-based Check Ins
时间窗: Over 3 months after baseline
Participant's engagement with the T2C intervention will be assessed via their response rate to prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as \>70% response rate. Participants received 1 text "How would you rate our emotional health this last week" on a likert scale of: 1 (excellent), 2 Very good, 3 good 4 fair 5 poor. If respondents answered "fair" or "Poor" they were routed to a website with psychoeducational videos and additional questions called a "web-based check in." The questions inquired what type of stressors the participant experienced contributing to the "Fair" or "Poor" ratings, what types of symptoms the participants noticed as a result of the indicated stressor and if participants felt they could manage their stress.
Mental Health Self-Efficacy
时间窗: 2 month timepoint
Mental health self-efficacy will be assessed via the Mental Health Self-Efficacy Scale (MHSES), as the primary outcome of Text2Connect Phase 2. The MHSES contains 6 items that are scored on a 10-point Likert Scale. Scores range from 6-60 with higher scores indicating greater confidence in participant's mental health self-efficacy.
Engagement With Intervention: Text Message Check-ins
时间窗: Over 3 months after baseline
Participant's engagement with the T2C intervention will be assessed via their response rate to SMS prompts, as the primary outcome of Text2Connect Phase 2. "High" engagement with T2C will be rated as \>70% response rate. All Intervention participants (n=34) received text-message check-ins with question: "How would you rate your emotional health this past week?" on a likert scale of: 1=excellent; 2=very good; 3=good;4=fair; 5=poor. Participants who did not respond to this message initially were sent a reminder with the same content each week of the intervention.
Usability & Satisfaction-PSSUQ
时间窗: 3 month follow up timepoint
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ), as the primary outcome of Text2Connect Phase 2. The PSSUQ utilize 16 items w/ response options ranging from 1-7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Scores are added and range from 16-112, with higher score indicating less satisfaction. Questions 1 to 16 result in the Overall score; Questions 1 to 6 result in System Usefulness score; Questions 7 to 12 result in Information Quality score; Questions 13 to 16 result in Interface Quality.
次要结局
- Mental Health Service Follow-through(3 month timepoint)
- Symptom Severity(3 month timepoint)
- Psychosocial Functioning(3 month timepoint)
研究者
Tina R Goldstein
Associate Professor of Psychiatry and Psychology
University of Pittsburgh