Community-based Implementation of an Emotion Regulation Intervention for Individuals With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Provider Self-Efficacy Scale Score
研究概览
简要总结
This is a hybrid type III implementation-effectiveness trial; this study design blends elements of implementation and clinical effectiveness research, with the primary aim of determining the utility of an implementation strategy and a secondary aim of assessing clinical outcomes associated with the implementation trial. Consistent with best practices for this type of design, the study team will conduct a randomized test of the effect of implementation strategy on effective delivery of the Online EmReg intervention in clinical practice. Specifically, the study team will compare Standard Training (a 3-hour on-demand training workshop) to Extended Training, (a 3-hour on-demand training workshop with 3 months of bi-weekly consultation). The research team's primary aim is to determine the optimal strategy to train clinicians in effectively delivering Online EmReg, and secondary aim is to assess patient improvement per clinician-administered DERS. Outcome measures will be assessed via self-report surveys, performance evaluations (via role-plays), and tracked clinician participation and fidelity. Study participation is expected to last up to 18 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed psychologist, social worker, or mental health counselor.
- •Training and experience in CBT, the framework for EmReg.
- •Experience working with people with TBI.
- •Experience providing group treatment.
- •A computer and internet to conduct group treatment via telehealth.
- •Actively treating ≥3 patients with TBI who are appropriate for EmReg (have emotion regulation difficulties based on clinician assessment).
- •Amenable to study tasks (e.g., completion of training, consultation, performance based role-play, data collection).
- •Not previously trained in EmReg.
- •Proficient in English.
排除标准
- •Not willing to conduct group treatment via telehealth.
- •Non-English speaking.
研究组 & 干预措施
Standard Training
Participants assigned to this arm will complete a 3-hour training workshop on the intervention. After completing the training, participants will be asked to implement the intervention into their routine clinical practice.
干预措施: Online EmReg (Behavioral)
Extended Training
Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training.
干预措施: Online EmReg (Behavioral)
Extended Training
Participants assigned to this arm will complete the same 3-hour training workshop on the intervention as Arm #1. After completing the training, participants will also be asked to implement the intervention into their routine clinical practice. However, participants in this group will be asked to attend bi-weekly consultation sessions with members of the study team for 3 months following training.
干预措施: Consultation Sessions (Behavioral)
结局指标
主要结局
Provider Self-Efficacy Scale Score
时间窗: Up to 18 months
A 7-item Likert Scale (not at all confident (1) to fully confident (7)) adapted for use with EmReg to assess provider confidence in delivering core components of the Online EmReg intervention. Total scores range from 26 to 182. Higher values indicate a higher level of self-efficacy. Used in the literature to reliably predict implementation of evidence-based interventions.
Performance Evaluation (via Role Plays)
时间窗: Post-3 hour EmReg training workshop
Assessed using a structured role play of EmReg groups in a simulated clinical setting. These role plays will be recorded and rated by a blinded evaluator. The evaluator will indicate the degrees to which the session goals were accomplished using a 15-item checklist. Each item will be rated a 0 (not introduced or covered), 1 (attempted/partially achieved), 2 (fully covered/achieved), or N/A (not applicable/relevant to session #). Participants can receive a total score of 0 to 30 on their performance-based role play. Higher values indicate higher achievement.
次要结局
- Training Satisfaction Rating Scale(Up to 18 months)
- Acceptability of Intervention Measure (AIM)(Up to 18 months)
- Feasibility of Intervention Measure (FIM) Scale(Up to 18 months)
- Intervention Appropriateness Measure (IAM) Scale(Up to 18 months)
- Number of EmReg groups scheduled and completed(Up to 18 months)
- Time between initial uptake and completion(Up to 18 months)
- Skills Acquisition Quiz for Providers (SAQ-P)(Up to 18 months)
- Number of participants who receive treatment(Up to 18 months)
- Difficulties in Emotion Regulation Scale (DERS)(Up to 18 months)
研究者
Maria Kajankova
Assistant Professor
Icahn School of Medicine at Mount Sinai