Improving Quality of Care in Child Mental Health Service Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 713
- 试验地点
- 2
- 主要终点
- Child Involvement Ratings Scale (CIRS)
研究概览
简要总结
The investigators recently completed an NIMH R34 in which they piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in the pilot evaluation. Moreover, all benchmarks for feasibility were met or exceeded. This study proposes to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes. The investigators will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. The investigators will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact.
详细描述
Assuring children access to the highest quality mental health care is a top national priority. Yet, quality of care continues to be highly variable in traditional service settings. Novel, scalable solutions are needed to address modifiable quality-of-care indicators in sustainable ways. To this end, provider fidelity and children's engagement are key correlates of clinical outcome and practical targets for intervention. There is tremendous opportunity to address both through technology. Studies in child education show that interactive games, touch-screen learning, and demonstration videos enhance engagement, knowledge, motivation, and learning. These benefits also may extend to the therapeutic context, where strategic integration of technology-based activities may enhance children's learning, strengthen the therapeutic alliance, and keep providers on protocol. The investigators recently completed an NIMH R34 in which they piloted a patient- and provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a wide range of symptoms using techniques shared by other treatments for emotional and behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos, interactive games, drawing applications) that are designed to facilitate provider-patient interactions in a way that enhances children's engagement and supports adherence to the treatment model. The tablet-based toolkit was very well received by children, caregivers, and providers in the picot evaluation and all benchmarks for feasibility were met or exceeded. The investigators propose to conduct a hybrid effectiveness-implementation trial to examine the extent to which the tablet intervention may improve fidelity, engagement, and children's mental health outcomes. The investigators will conduct a randomized controlled trial with 120 mental health providers and 360 families in partnership with dozens of clinics in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by independent, blind evaluators. Sessions will be videorecorded for observational coding of engagement and fidelity by independent raters blind to study hypotheses. The investigators will also examine costs and conduct semi-structured interviews with families, providers, supervisors, and agency leaders to inform future dissemination and implementation initiatives. Technology-based resources that are scalable, easy to use, and designed for efficient integration into everyday practice may have sustained national impact.
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)
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •victim of at least one potentially traumatic event (e.g. sexual/physical assault, witnessed violence, disaster, serious accident)
- •have at least one symptom on each PTSD symptom cluster (re-experiencing, avoidance, hyperarousal)
排除标准
- •exhibits psychotic symptoms (active hallucinations, delusions, impaired thought processes) by caregiver or child
- •significant cognitive disabilities, developmental delays, or pervasive developmental disorder
- •active suicidal or homicidal ideations
- •no consistent caregiver available to participate
结局指标
主要结局
Child Involvement Ratings Scale (CIRS)
时间窗: 3 Month Timeline
Child engagement will be measured via coding of audiotaped sessions by independent, trained raters who are blind to study purpose and hypotheses. The Child Involvement Ratings Scale (CIRS) will be used to code child engagement. Ten "child involvement" items-6 positive, 4 negative- are rated for each session on a 6-point scale. The minimum total score will be 0 and the maximum score is 50. For the outcome, a single average value will be presented. The positive-involvement items emphasize the extent to which children initiate discussions, demonstrate enthusiasm, self-disclose, and demonstrate understanding. Negative-involvement items address withdrawal or avoidance in treatment. Coders provide ratings based on two 10-min segments of session audiotapes (beginning at min 10 and min 40). Screening was conducted on enrolled participants.
Provider Treatment Fidelity (TPOCS)
时间窗: 3 Month Timeline
Fidelity to the TF-CBT protocol will be measured by independent, trained raters who are blind to the study purpose and hypotheses, coding audiotaped treatment sessions. The TF-CBT Version of the Therapy Process Observational Coding System for Child Psychotherapy (TF-CBT TPOCS-S), modified for the eTF-CBT condition, will be used to assess provider fidelity to each TF-CBT component. Two raters will review video-recorded treatment sessions, assessing the presence or absence of specific techniques and rating their extensiveness on a 6-point scale. The total score will range from a minimum of 0 to the maximum 78. The outcome will be presented as a single average value.
次要结局
- Working Alliance Inventory (WAI-short Form)(3 Month Timeline)
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- Therapeutic Alliance Scale for Children (TASC)(3 Month)
- Child/Adolescent Satisfaction Questionnaire (CASQ).(3 Month)
- The Shame Measure(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- The Child and Adolescent Trauma Screen (CATS) - Youth Version(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- Caregiver Satisfaction Questionnaire (CSQ)(3 Month)
- Brief Problems Monitor (BPM)(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- Center for Epidemiologic Studies Depression Scale (CESD-R).(baseline, 3, 6, 9, 12 months Timeline)
- The Child and Adolescent Trauma Screen (CATS) - Caregiver Version(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- The Kessler 6(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- Evidence-Based Practice Attitude Scale (EBPAS)(baseline, post baseline at 12 Months)
- The Alabama Parenting Questionnaire(Baseline, 3 Month, 6 Month, 9 Month, 12 Month)
- Knowledge of Behavioral Principles as Applied to Children(Baseline, Post Baseline at 12 months)
- Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)(baseline, Post baseline at 12 months)
- Computer Assisted Therapy Attitudes Scale(baseline, post baseline at 12 months)
- Organizational Readiness for Implementing Change(baseline, post baseline at 12 months)
- TF-CBT Organizational Support Measure(baseline, post baseline at 12 month)
- Burnout Measure(baseline)