Improving Quality of Care in Child Mental Health Service Settings

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.

Study Overview

• Status: Completed
• Conditions: Child Abuse; Post Traumatic Stress Disorder; Technology
• Intervention / Treatment: Behavioral: TFCBT; Behavioral: eTFCBT

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.

• Study Type: Interventional
• Enrollment (Actual): 713
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual; Trauma Focused Cognitive Behavioral Therapy	Behavioral: TFCBT; treatment as usual
Experimental: Tablet-Facilitated TF-CBT; Standard treatment with the addition of in-treatment/session iPad activities	Behavioral: eTFCBT; tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Involvement Ratings Scale (CIRS)	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.	3 Month Timeline
Provider Treatment Fidelity (TPOCS)	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.	3 Month Timeline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Each questions has a scaling score of 0-3. With 0 being the lowest value stating 'Not at all' and 3 being the highest value stating 'A lot'. Total score over 15 is indicative of significant levels of depressive symptoms, showing worse outcome.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Therapeutic Alliance Scale for Children (TASC)	The Therapeutic Alliance Score for Children is a 12-item measure of the child's alliance with the therapist using a 4-pt scale. It has good internal consistency and interrupter reliability. Measuring therapeutic alliance is one of the most reliable ways to determine the strength of this bond, and it allows the therapist to identify how comfortable their client might be in sharing their thoughts, experiences, struggles and goals with them throughout care. This scale completed by the adolescent participant aged 12-18, and there is a parallel version for the therapist to complete. Each item is rated on a 4 point scale ranging with 0 being the lowest value 'not at all' to 3 the highest value 'very much'. The lowest possible total score being 0 and the highest possible score (total score) would be 36. The higher the total score represents better outcome showing the strength of the child and therapist bond.	3 Month
Child/Adolescent Satisfaction Questionnaire (CASQ).	The Child/Adolescent Satisfaction Questionnaire is a 15-item instrument that assesses child satisfaction with mental health treatment. The last three questions are open ended questions that do not provide value (these will not be measured/scored). The first twelve questions have a scoring scale between 1-5, with 1 being the lowest value ('Very much False') and 5 being the highest value with ('Very much True'). The total minimum score is 12 and the maximum total score being 60. The higher the total score represents a better outcome. Screening was given to enrolled children.	3 Month
The Shame Measure	4-item instrument that assesses feelings of shame following abuse. With a score ranging 0-2, 0 being the lowest value 'Not true' and 2 being the highest value 'Very true'. The lowest possible total score is 0 and the highest possible total score is 8. The higher the score meant a worse outcome. Screening completed by enrolled children.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
The Child and Adolescent Trauma Screen (CATS) - Youth Version	35-item instrument that assesses exposure to traumatic events and all 20 Diagnostic and Statistical Manual of Mental Disorder- Fifth Edition, Symptoms of PTSD. 20 items are scored ranging total value of 0-60; the minimum total score being 0 and the maximum total score being 60. Values ranging between 0-3, with the lowest possible score of 0 being 'Not at All' and 3 being the highest with 'All the time.' The higher values represent a worst outcome. Screenings complete with enrolled children.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Caregiver Satisfaction Questionnaire (CSQ)	The Caregiver Satisfaction Questionnaire is a 15-item instrument that assesses caregiver satisfaction with mental health treatment. The last three questions are open ended questions that do not provide value (these will not be measured/scored). The first twelve questions have a scoring scale between 1-5, with 1 being the lowest value ('Very much False') and 5 being the highest value with ('Very much True').The minimum total score being 12 and the maximum total scores being 60. The higher the score represents a better outcome. Assessment given to only enrolled parent/caregivers and children. Screening was completed by enrolled caregivers/parents.	3 Month
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). Scoring ranging between 1-7, with 1 being the lowest ('Never') and 7 being the highest with ('Always'). Total scores ranging between 12-84. Screening was completed by enrolled caregivers/parents. Higher score indicate a better therapeutic alliance.	3 Month Timeline
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. The values range from 0-2 with 0 being the lowest value of 'Not True' and 2 being the highest value of 'Very True'. The lowest possible total score is 0 and the total highest possible score being 38. The higher the total score the worse outcome. Screening was completed with enrolled caregivers/parents.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Center for Epidemiologic Studies Depression Scale (CESD-R).	The Center for Epidemiologic Studies Depression Scale is a 20-item self-report scale of depression completed by the enrolled caregiver. It is widely used and demonstrates excellent psychometric properties. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. A score equal to or above 15 indicates a person at risk for clinical depression. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.	baseline, 3, 6, 9, 12 months Timeline
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version	35-item parent version of the CATS-Youth. CATS are given to enrolled Caregivers. A total symptom score is calculated by summing up the raw scores of items 1-20 (possible range = 0-60). The lowest value score of 0 being 'Never' and the highest value of 3 'Almost Always.' We recommend to use a cut-off ≥ 21 as indication of a clinically relevant level of symptoms. The higher the score means a worse outcome. Screening completed by enrolled caregiver/parents. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
The Alabama Parenting Questionnaire	42-item measure to assess parenting practices. 13 questions were pulled to be utilized in these assessments. Scoring ranges are from 1- 5: 1 being 'Never', 2 being 'Almost never', 3 being 'Sometimes, 4 being 'Often', and 5 being 'Always'. Total minimum score being 13 and the highest possible score being 65. The higher score means worse outcome. With Assessment was given to Enrolled Caregivers/parents. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
The Kessler 6	Widely used the Kessler 6 measure of general distress that is well-validated. Assessment was given to Enrolled Caregivers.There are 6 items that are asked and each value scores ranging 0-4, with 0 being 'none of the time' and 4 being 'All of the time". With minimum total score would be 0 and maximum score would be 24. According to the scoring criteria proposed by Kessler 6, persons with a score of 13 or greater are likely to be experiencing severe mental illness. The higher total score represented a worse outcome. Screening was completed by enrolled caregivers/parents. Enrolled caregivers had multiple children enrolled meaning that caregivers with multiple children were asked more than once for each time point.	Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Evidence-Based Practice Attitude Scale (EBPAS)	15 items, assessing providers' perceptions of appeal of Evidence-Based Therapy, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).Scoring ranges from 0-4, with 0 being the lowest value ('Not at all') and 4 being the highest value ('To a Very Great Extent'). With the minimum score being 0 and the maximum score being 60. The higher Evidence-Based Practice Attitude Scale total score indicating more global positive attitudes toward adoption of Evidence-Based Practice.The higher the value reprents a better outcome. This assessment was given to enrolled providers.	baseline, post baseline at 12 Months
Knowledge of Behavioral Principles as Applied to Children	Assess understanding of the application of behavioral principles to youth. With the minimum score of 0 and maximum score of 25. the higher values represent a better outcome. Internal consistency=.42-.84; sensitivity to change. Screening completed with Enrolled Providers.	Baseline, Post Baseline at 12 months
Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)	12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties. Scaling is ranged from 1 to 5, with 1 being the lowest value with ('Completely Disagree') and 5 being the highest value ('Completely Agree'). With the total possible score ranging 12-60. With the lowest possible total score being 12 and the highest possible score being 60. The higher the values represent a better outcome. The higher scores indicate greater acceptability, appropriateness, and feasibility. Screening completed with enrolled providers.	baseline, Post baseline at 12 months
Computer Assisted Therapy Attitudes Scale	8-item measure design to assess attitudes toward computer use in treatment. Scaling on each question ranges 1-5 with 1 being the lowest value ('Strongly Disagree') and 5 being the highest value ('Strongly Agree'). The minimum total score would be 8 and the maximum total score being 40. The higher the value represents a better outcome. Assessment given only to enrolled providers.	baseline, post baseline at 12 months
Organizational Readiness for Implementing Change	12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices. With values ranging between 1-5, 1 being the lowest of 'Disagree' and 5 being the highest with 'Agree'. The total minimum score being 12 and total maximum number being 60. The higher values represent a better outcome. Lower scores represent less organizational readiness for implementing change; Higher scores represent a more favorable organizational readiness for implementing change	baseline, post baseline at 12 months
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). With values ranging between 1-5. 1 being the lowest with ' Strongly Disagree' and 5 being the highest with 'strongly agree'. The total minimum scores being 19 and the total maximum total scores being 95. The higher values represent a better outcome. Screening given to enrolled providers.	baseline, post baseline at 12 month
Burnout Measure	screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do. Scorings will range from 4- 28. Scaling value between 1-7, with 1 being the lowest value of 'Never' and 7 with the highest value of 'everyday'. Higher scores will mean worse outcome. Screening complete by enrolled providers.	baseline

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: R01MH110620 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No