Text2Connect, Component 2 of iCHART (Integrated Care to Help At-Risk Teens)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Attendance to Treatment
研究概览
简要总结
This study proposes to develop and examine a personalized, text-based intervention designed to improve engagement with mental health (MH) treatment.
详细描述
Text2Connect (T2C) aims to increase perceived susceptibility/severity of depression/suicidality and decrease stigma in at-risk adolescents and their parents. The investigators hypothesize that modification of patient beliefs leads to change talk, thereby increasing the experience of discrepancy which affects motivation for change. These experiences in turn influence decisional balance away from ambivalence toward readiness for change.
Assignment of Interventions:
This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. As a result of the change, there are some TAU participants included in this study.
For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
This study will pilot Text2Connect in community pediatric and mental health practices using a stepped wedge design (n = 50 adolescents).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth aged 12-26 yo Own a cell phone with text message capability Biological or adoptive parent is willing to provide informed consent for teen to participate Youth speaks and understands English
- •Positive PHQ score or provider determines youth has depressive symptoms based on clinical interaction and refers youth to the study (in cases when PHQ is not available and study staff will complete the PHQ during the screening) OR Provider can refer if they are unclear if symptoms are depressive and PHQ scoring will be used to determine youth's eligibility. OR Screening Wizard screening questionnaire (which includes the PHQ and depressive symptom questions) indicates depression OR provider indicates there is a concern that youth has mood or behavioral problem.
- •Referred to mental health care OR screening wizard questionnaire (which indicates if provider makes referral to mental health care)
- •PHQ-9 scores:
- •Score of 8 or higher on PHQ-8 -or- Score of 1 or higher on #9 of PHQ-9 suicidality item
- •Parent inclusion criteria:
- •Age 18 or older Own a cell phone with text message capability Speaks and understands English Parent of a youth that scores positive on the PHQ-8 or #9 as described above Parent of a youth who has been referred to mental health treatment
排除标准
- •Non English speaking No parent willing to provide informed consent No cell phone with text messaging capability Is currently experiencing mania or psychosis Evidence of an intellectual or developmental disorder (IDD) Life threatening medical condition that requires immediate treatment Other cognitive or medical condition preventing youth from understanding study and/or participating.
- •Not referred to mental health care
- •Parent exclusion criteria:
- •No cell phone with text messaging capability Child meets exclusion criteria as described above Other cognitive or medical condition preventing parent from understanding study and/or participating.
研究组 & 干预措施
Text2Connect
Participants receiving Text2Connect (T2C) personalized messages aimed at increasing motivations in at-risk adolescents and their parents. The most salient of the following behavior change techniques will be selected and targeted messaging will be deployed on the participants' phone: psychoeducation, cued mood monitoring, adolescent-parent communication prompts, cognitive bias modification, and cues to action. Intervention material will be tailored to baseline characteristics and T2C will generate reports to providers.
干预措施: Text2Connect (Behavioral)
结局指标
主要结局
Attendance to Treatment
时间窗: Week 12 follow up after Baseline
Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)
Attendance to Treatment
时间窗: Week 4 follow up after Baseline
Attendance to the embedded mental health care appointments will be assessed via electronic health record (EHR), as the primary outcome of Text2Connect (T2C)
次要结局
- Usability & Satisfaction(At exit interview either following week 4 study visit or week 12 study visit (depending on when youth attend 1st mental health care appointment))
- Number of SMS Messages Answered by Participants(Week 12 follow up after Baseline)
- Service Utilization-Baseline(At Baseline phone visit)
- Service Utilization-Follow Up 4 Weeks(Week 4 follow up after Baseline)
- Service Utilization-Follow up 12 Weeks(Week 12 follow up after Baseline)
- Number of SMS Messages Answered by Participants(At Baseline phone visit)
- Number of SMS Messages Answered by Participants(Week 4 follow up after Baseline)
研究者
Tina R Goldstein
Associate Professor of Psychiatry and Psychology
University of Pittsburgh