Improving Quality of Care in Child Mental Health Service Settings

Post Traumatic Stress Disorder Clinical Trial

Official title:

Improving Quality of Care in Child Mental Health Service Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305458
• Other study ID #: R01MH110620
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 23, 2023

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: October 23, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Technology

Intervention

Behavioral:
• TFCBT
treatment as usual
• eTFCBT
tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Involvement Ratings Scale	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), a 6-item scale that measures child engagement for each session, will be used. Four "positive" involvement items and two "negative" involvement items are rated for each session on a 6-point scale ("not at all" to "a great deal" present). 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).	will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
Primary	Provider Treatment Fidelity	Fidelity to the TF-CBT protocol will be measured via coding of videotaped treatment sessions by independent, trained raters who are blind to study purpose and hypotheses. Ratings will be completed using the TF-CBT Version of the Therapy Process Observational Coding System for Child Psychotherapy (TF-CBT TPOCS-S), a behaviorally specific checklist of TF-CBT provider behavior that we have modified for the current study to ensure relevance to the eTF-CBT condition. This checklist will be used to calculate providers' fidelity to each TF-CBT component. Two independent raters will listen to video-recorded treatment session tapes and complete the TF-CBT TPOCS-S to code the presence/absence of specific treatment techniques depicted on the tapes.	will be assessed throughout the course of treatment; an expected duration of 12-20 weeks
Secondary	Center for Epidemiological Studies Depression Scale for Children (CES-DC)	assesses the severity of depressive symptomatology in children. It is a 20-item self-report measure with possible scores ranging from 0-60. Scores over 15 are indicative of significant levels of depressive symptoms.	baseline, 3, 6, 9, 12 months post baseline
Secondary	Therapeutic Alliance Scale for Children (TASC)	The TASC is an 8-item measure of the child's alliance with the therapist using a 4-pt scale. It has good internal consistency and interrater reliability.	baseline, 3, 6, 9, 12 months post baseline
Secondary	Child/Adolescent Satisfaction Questionnaire (CASQ).	The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.	baseline, 3, 6, 9, 12 months post baseline
Secondary	The Shame Measure	4-item instrument that assesses feelings of shame following abuse.	baseline, 3, 6, 9, 12 months post baseline
Secondary	The Child and Adolescent Trauma Screen (CATS) - Youth Version	35-item instrument that assesses exposure to traumatic events and all 20 DSM-V symptoms of PTSD.	baseline, 3, 6, 9, 12 months post baseline
Secondary	Caregiver Satisfaction Questionnaire (CSQ)	The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.	baseline, 3, 6, 9, 12 months post baseline
Secondary	Working Alliance Inventory (WAI-short form)	The WAI is a 12-item measure of the parent-therapist alliance using a 7-point scale (never to always).	baseline, 3, 6, 9, 12 months post baseline
Secondary	Brief Problems Monitor (BPM)	The BPM is a 19-item measure of emotional and behavioral functioning in children. The BPM is well-validated and comparable to the lengthier Child Behavior Checklist.	baseline, 3, 6, 9, 12 months post baseline
Secondary	Center for Epidemiologic Studies Depression Scale (CESD-R).	The CESD-R is a 20-item self-report scale of depression. It is widely used and demonstrates excellent psychometric properties.	baseline, 3, 6, 9, 12 months post baseline
Secondary	The Child and Adolescent Trauma Screen (CATS) - Caregiver Version	35-item parent version of the CATS-Youth.	baseline, 3, 6, 9, 12 months post baseline
Secondary	The Alabama Parenting Questionnaire	42-item measure to assess parenting practices.	baseline, 3, 6, 9, 12 months post baseline
Secondary	The Kessler 6	widely used 6-item measure of general distress that is well-validated.	baseline, 3, 6, 9, 12 months post baseline
Secondary	Evidence-Based Practice Attitude Scale (EBPAS)	15 items, assessing providers' perceptions of appeal of EBT, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).	baseline, post baseline
Secondary	Knowledge of Behavioral Principles as Applied to Children	assess understanding of the application of behavioral principles to youth. Internal consistency=.42-.84; sensitivity to change.	baseline, post baseline
Secondary	Acceptability, Appropriateness and Feasibility Measure (	12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties.	baseline, post baseline
Secondary	Computer Assisted Therapy Attitudes Scale	8-item measure design to assess attitudes toward computer use in treatment.	baseline, post baseline
Secondary	Organizational Readiness for Implementing Change	12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.	baseline, post baseline
Secondary	TF-CBT Organizational Support Measure	19-item instrument to assess a community mental health organization's activities related to the delivery of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT).	baseline, post baseline
Secondary	Burnout Measure	screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do.	baseline, post baseline