Improving Quality of Care in Child Mental Health Service Settings
Primary Purpose
Post Traumatic Stress Disorder, Technology, Child Abuse
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TFCBT
eTFCBT
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Treatment as usual
Tablet-Facilitated TF-CBT
Arm Description
Trauma Focused Cognitive Behavioral Therapy
Standard treatment with the addition of in-treatment/session iPad activities
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
Child/Adolescent Satisfaction Questionnaire (CASQ).
The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.
The Shame Measure
4-item instrument that assesses feelings of shame following abuse.
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.
Caregiver Satisfaction Questionnaire (CSQ)
The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.
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).
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.
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.
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
35-item parent version of the CATS-Youth.
The Alabama Parenting Questionnaire
42-item measure to assess parenting practices.
The Kessler 6
widely used 6-item measure of general distress that is well-validated.
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).
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.
Acceptability, Appropriateness and Feasibility Measure (
12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties.
Computer Assisted Therapy Attitudes Scale
8-item measure design to assess attitudes toward computer use in treatment.
Organizational Readiness for Implementing Change
12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.
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).
Burnout Measure
screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do.
Full Information
NCT ID
NCT03305458
First Posted
October 4, 2017
Last Updated
April 4, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03305458
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Technology, Child Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Trauma Focused Cognitive Behavioral Therapy
Arm Title
Tablet-Facilitated TF-CBT
Arm Type
Experimental
Arm Description
Standard treatment with the addition of in-treatment/session iPad activities
Intervention Type
Behavioral
Intervention Name(s)
TFCBT
Intervention Description
treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
eTFCBT
Intervention Description
tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
Primary Outcome Measure Information:
Title
Child Involvement Ratings Scale
Description
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).
Time Frame
will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
Title
Provider Treatment Fidelity
Description
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.
Time Frame
will be assessed throughout the course of treatment; an expected duration of 12-20 weeks
Secondary Outcome Measure Information:
Title
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Description
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.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Therapeutic Alliance Scale for Children (TASC)
Description
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.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Child/Adolescent Satisfaction Questionnaire (CASQ).
Description
The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
The Shame Measure
Description
4-item instrument that assesses feelings of shame following abuse.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
The Child and Adolescent Trauma Screen (CATS) - Youth Version
Description
35-item instrument that assesses exposure to traumatic events and all 20 DSM-V symptoms of PTSD.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Caregiver Satisfaction Questionnaire (CSQ)
Description
The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Working Alliance Inventory (WAI-short form)
Description
The WAI is a 12-item measure of the parent-therapist alliance using a 7-point scale (never to always).
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Brief Problems Monitor (BPM)
Description
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.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Center for Epidemiologic Studies Depression Scale (CESD-R).
Description
The CESD-R is a 20-item self-report scale of depression. It is widely used and demonstrates excellent psychometric properties.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
Description
35-item parent version of the CATS-Youth.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
The Alabama Parenting Questionnaire
Description
42-item measure to assess parenting practices.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
The Kessler 6
Description
widely used 6-item measure of general distress that is well-validated.
Time Frame
baseline, 3, 6, 9, 12 months post baseline
Title
Evidence-Based Practice Attitude Scale (EBPAS)
Description
15 items, assessing providers' perceptions of appeal of EBT, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).
Time Frame
baseline, post baseline
Title
Knowledge of Behavioral Principles as Applied to Children
Description
assess understanding of the application of behavioral principles to youth. Internal consistency=.42-.84; sensitivity to change.
Time Frame
baseline, post baseline
Title
Acceptability, Appropriateness and Feasibility Measure (
Description
12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties.
Time Frame
baseline, post baseline
Title
Computer Assisted Therapy Attitudes Scale
Description
8-item measure design to assess attitudes toward computer use in treatment.
Time Frame
baseline, post baseline
Title
Organizational Readiness for Implementing Change
Description
12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.
Time Frame
baseline, post baseline
Title
TF-CBT Organizational Support Measure
Description
19-item instrument to assess a community mental health organization's activities related to the delivery of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT).
Time Frame
baseline, post baseline
Title
Burnout Measure
Description
screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do.
Time Frame
baseline, post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Quality of Care in Child Mental Health Service Settings
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