Clinical trial NCT03305458: Improving Quality of Care in Child Mental Health Service Settings
Official title: Improving Quality of Care in Child Mental Health Service Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Technology
Child Abuse
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 713
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Child Involvement Ratings Scale (CIRS)
timeFrame: 3 Month Timeline
measure: Provider Treatment Fidelity (TPOCS)
timeFrame: 3 Month Timeline
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: Therapeutic Alliance Scale for Children (TASC)
timeFrame: 3 Month
measure: Child/Adolescent Satisfaction Questionnaire (CASQ).
timeFrame: 3 Month
measure: The Shame Measure
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: The Child and Adolescent Trauma Screen (CATS) - Youth Version
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: Caregiver Satisfaction Questionnaire (CSQ)
timeFrame: 3 Month
measure: Working Alliance Inventory (WAI-short Form)
timeFrame: 3 Month Timeline
measure: Brief Problems Monitor (BPM)
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: Center for Epidemiologic Studies Depression Scale (CESD-R).
timeFrame: baseline, 3, 6, 9, 12 months Timeline
measure: The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: The Alabama Parenting Questionnaire
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: The Kessler 6
timeFrame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
measure: Evidence-Based Practice Attitude Scale (EBPAS)
timeFrame: baseline, post baseline at 12 Months
measure: Knowledge of Behavioral Principles as Applied to Children
timeFrame: Baseline, Post Baseline at 12 months
measure: Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)
timeFrame: baseline, Post baseline at 12 months
measure: Computer Assisted Therapy Attitudes Scale
timeFrame: baseline, post baseline at 12 months
measure: Organizational Readiness for Implementing Change
timeFrame: baseline, post baseline at 12 months
measure: TF-CBT Organizational Support Measure
timeFrame: baseline, post baseline at 12 month
measure: Burnout Measure
timeFrame: baseline
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: