<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03305458</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH110620</org_study_id>
    <nct_id>NCT03305458</nct_id>
  </id_info>
  <brief_title>Improving Quality of Care in Child Mental Health Service Settings</brief_title>
  <official_title>Improving Quality of Care in Child Mental Health Service Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators recently completed an NIMH R34 in which they piloted a patient- and&#xD;
      provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused&#xD;
      Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a&#xD;
      wide range of symptoms using techniques shared by other treatments for emotional and&#xD;
      behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos,&#xD;
      interactive games, drawing applications) that are designed to facilitate provider-patient&#xD;
      interactions in a way that enhances children's engagement and supports adherence to the&#xD;
      treatment model. The tablet-based toolkit was very well received by children, caregivers, and&#xD;
      providers in the pilot evaluation. Moreover, all benchmarks for feasibility were met or&#xD;
      exceeded. This study proposes to conduct a hybrid effectiveness-implementation trial to&#xD;
      examine the extent to which the tablet intervention may improve fidelity, engagement, and&#xD;
      children's mental health outcomes. The investigators will conduct a randomized controlled&#xD;
      trial with 120 mental health providers and 360 families in partnership with dozens of clinics&#xD;
      in the Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs.&#xD;
      standard TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be&#xD;
      recruited. Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted&#xD;
      by independent, blind evaluators. Sessions will be videorecorded for observational coding of&#xD;
      engagement and fidelity by independent raters blind to study hypotheses. The investigators&#xD;
      will also examine costs and conduct semi-structured interviews with families, providers,&#xD;
      supervisors, and agency leaders to inform future dissemination and implementation&#xD;
      initiatives. Technology-based resources that are scalable, easy to use, and designed for&#xD;
      efficient integration into everyday practice may have sustained national impact.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assuring children access to the highest quality mental health care is a top national&#xD;
      priority. Yet, quality of care continues to be highly variable in traditional service&#xD;
      settings. Novel, scalable solutions are needed to address modifiable quality-of-care&#xD;
      indicators in sustainable ways. To this end, provider fidelity and children's engagement are&#xD;
      key correlates of clinical outcome and practical targets for intervention. There is&#xD;
      tremendous opportunity to address both through technology. Studies in child education show&#xD;
      that interactive games, touch-screen learning, and demonstration videos enhance engagement,&#xD;
      knowledge, motivation, and learning. These benefits also may extend to the therapeutic&#xD;
      context, where strategic integration of technology-based activities may enhance children's&#xD;
      learning, strengthen the therapeutic alliance, and keep providers on protocol. The&#xD;
      investigators recently completed an NIMH R34 in which they piloted a patient- and&#xD;
      provider-informed tablet-based toolkit designed to facilitate delivery of Trauma-Focused&#xD;
      Cognitive Behavioral Therapy (TF-CBT) - a treatment that was selected because it addresses a&#xD;
      wide range of symptoms using techniques shared by other treatments for emotional and&#xD;
      behavioral disorders. The tablet-based toolkit consists of numerous components (e.g., videos,&#xD;
      interactive games, drawing applications) that are designed to facilitate provider-patient&#xD;
      interactions in a way that enhances children's engagement and supports adherence to the&#xD;
      treatment model. The tablet-based toolkit was very well received by children, caregivers, and&#xD;
      providers in the picot evaluation and all benchmarks for feasibility were met or exceeded.&#xD;
      The investigators propose to conduct a hybrid effectiveness-implementation trial to examine&#xD;
      the extent to which the tablet intervention may improve fidelity, engagement, and children's&#xD;
      mental health outcomes. The investigators will conduct a randomized controlled trial with 120&#xD;
      mental health providers and 360 families in partnership with dozens of clinics in the&#xD;
      Carolinas and Florida. Providers will be assigned randomly to tablet-facilitated vs. standard&#xD;
      TF-CBT. Youth aged 8-16 years with clinically elevated symptoms of PTSD will be recruited.&#xD;
      Baseline and 3-, 6-, 9-, and 12-month post-baseline assessments will be conducted by&#xD;
      independent, blind evaluators. Sessions will be videorecorded for observational coding of&#xD;
      engagement and fidelity by independent raters blind to study hypotheses. The investigators&#xD;
      will also examine costs and conduct semi-structured interviews with families, providers,&#xD;
      supervisors, and agency leaders to inform future dissemination and implementation&#xD;
      initiatives. Technology-based resources that are scalable, easy to use, and designed for&#xD;
      efficient integration into everyday practice may have sustained national impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child Involvement Ratings Scale</measure>
    <time_frame>will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)</time_frame>
    <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 &quot;positive&quot; involvement items and two &quot;negative&quot; involvement items are rated for each session on a 6-point scale (&quot;not at all&quot; to &quot;a great deal&quot; 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Treatment Fidelity</measure>
    <time_frame>will be assessed throughout the course of treatment; an expected duration of 12-20 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale for Children (CES-DC)</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic Alliance Scale for Children (TASC)</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child/Adolescent Satisfaction Questionnaire (CASQ).</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Shame Measure</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>4-item instrument that assesses feelings of shame following abuse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Child and Adolescent Trauma Screen (CATS) - Youth Version</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>35-item instrument that assesses exposure to traumatic events and all 20 DSM-V symptoms of PTSD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Satisfaction Questionnaire (CSQ)</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory (WAI-short form)</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>The WAI is a 12-item measure of the parent-therapist alliance using a 7-point scale (never to always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Problems Monitor (BPM)</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CESD-R).</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>The CESD-R is a 20-item self-report scale of depression. It is widely used and demonstrates excellent psychometric properties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Child and Adolescent Trauma Screen (CATS) - Caregiver Version</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>35-item parent version of the CATS-Youth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Alabama Parenting Questionnaire</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>42-item measure to assess parenting practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Kessler 6</measure>
    <time_frame>baseline, 3, 6, 9, 12 months post baseline</time_frame>
    <description>widely used 6-item measure of general distress that is well-validated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence-Based Practice Attitude Scale (EBPAS)</measure>
    <time_frame>baseline, post baseline</time_frame>
    <description>15 items, assessing providers' perceptions of appeal of EBT, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of Behavioral Principles as Applied to Children</measure>
    <time_frame>baseline, post baseline</time_frame>
    <description>assess understanding of the application of behavioral principles to youth. Internal consistency=.42-.84; sensitivity to change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability, Appropriateness and Feasibility Measure (</measure>
    <time_frame>baseline, post baseline</time_frame>
    <description>12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computer Assisted Therapy Attitudes Scale</measure>
    <time_frame>baseline, post baseline</time_frame>
    <description>8-item measure design to assess attitudes toward computer use in treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organizational Readiness for Implementing Change</measure>
    <time_frame>baseline, post baseline</time_frame>
    <description>12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TF-CBT Organizational Support Measure</measure>
    <time_frame>baseline, post baseline</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burnout Measure</measure>
    <time_frame>baseline, post baseline</time_frame>
    <description>screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">259</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Technology</condition>
  <condition>Child Abuse</condition>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trauma Focused Cognitive Behavioral Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet-Facilitated TF-CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard treatment with the addition of in-treatment/session iPad activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TFCBT</intervention_name>
    <description>treatment as usual</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eTFCBT</intervention_name>
    <description>tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)</description>
    <arm_group_label>Tablet-Facilitated TF-CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  victim of at least one potentially traumatic event (e.g. sexual/physical assault,&#xD;
             witnessed violence, disaster, serious accident)&#xD;
&#xD;
          -  have at least one symptom on each PTSD symptom cluster (re-experiencing, avoidance,&#xD;
             hyperarousal)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  exhibits psychotic symptoms (active hallucinations, delusions, impaired thought&#xD;
             processes) by caregiver or child&#xD;
&#xD;
          -  significant cognitive disabilities, developmental delays, or pervasive developmental&#xD;
             disorder&#xD;
&#xD;
          -  active suicidal or homicidal ideations&#xD;
&#xD;
          -  no consistent caregiver available to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03305458
org study id: R01MH110620
nct id: NCT03305458
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Child Involvement Ratings Scale
time frame: will be assessed throughout the course of treatment (expected to be 12-20 weeks in duration for each participant)
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).
measure: Provider Treatment Fidelity
time frame: will be assessed throughout the course of treatment; an expected duration of 12-20 weeks
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.
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
time frame: baseline, 3, 6, 9, 12 months post baseline
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.
measure: Therapeutic Alliance Scale for Children (TASC)
time frame: baseline, 3, 6, 9, 12 months post baseline
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.
measure: Child/Adolescent Satisfaction Questionnaire (CASQ).
time frame: baseline, 3, 6, 9, 12 months post baseline
description: The CASQ is a 15-item instrument that assesses child satisfaction with mental health treatment.
measure: The Shame Measure
time frame: baseline, 3, 6, 9, 12 months post baseline
description: 4-item instrument that assesses feelings of shame following abuse.
measure: The Child and Adolescent Trauma Screen (CATS) - Youth Version
time frame: baseline, 3, 6, 9, 12 months post baseline
description: 35-item instrument that assesses exposure to traumatic events and all 20 DSM-V symptoms of PTSD.
measure: Caregiver Satisfaction Questionnaire (CSQ)
time frame: baseline, 3, 6, 9, 12 months post baseline
description: The CSQ is a 15-item instrument that assesses caregiver satisfaction with mental health treatment.
measure: Working Alliance Inventory (WAI-short form)
time frame: baseline, 3, 6, 9, 12 months post baseline
description: The WAI is a 12-item measure of the parent-therapist alliance using a 7-point scale (never to always).
measure: Brief Problems Monitor (BPM)
time frame: baseline, 3, 6, 9, 12 months post baseline
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.
measure: Center for Epidemiologic Studies Depression Scale (CESD-R).
time frame: baseline, 3, 6, 9, 12 months post baseline
description: The CESD-R is a 20-item self-report scale of depression. It is widely used and demonstrates excellent psychometric properties.
measure: The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
time frame: baseline, 3, 6, 9, 12 months post baseline
description: 35-item parent version of the CATS-Youth.
measure: The Alabama Parenting Questionnaire
time frame: baseline, 3, 6, 9, 12 months post baseline
description: 42-item measure to assess parenting practices.
measure: The Kessler 6
time frame: baseline, 3, 6, 9, 12 months post baseline
description: widely used 6-item measure of general distress that is well-validated.
measure: Evidence-Based Practice Attitude Scale (EBPAS)
time frame: baseline, post baseline
description: 15 items, assessing providers' perceptions of appeal of EBT, openness to innovation, perceived divergence with usual care (alphas .59-.90; M=.77).
measure: Knowledge of Behavioral Principles as Applied to Children
time frame: baseline, post baseline
description: assess understanding of the application of behavioral principles to youth. Internal consistency=.42-.84; sensitivity to change.
measure: Acceptability, Appropriateness and Feasibility Measure (
time frame: baseline, post baseline
description: 12-item measure to monitor and evaluate implementation efforts. This measure has been shown to have solid psychometric properties.
measure: Computer Assisted Therapy Attitudes Scale
time frame: baseline, post baseline
description: 8-item measure design to assess attitudes toward computer use in treatment.
measure: Organizational Readiness for Implementing Change
time frame: baseline, post baseline
description: 12-item measure designed to assess an organization's readiness to implement new policies, programs, and practices.
measure: TF-CBT Organizational Support Measure
time frame: baseline, post baseline
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).
measure: Burnout Measure
time frame: baseline, post baseline
description: screener that assesses providers' feelings about their work, and their perceptions of how their co-workers feel about the work they do.
arm group label: Treatment as usual
arm group type: Active Comparator
description: Trauma Focused Cognitive Behavioral Therapy
arm group label: Tablet-Facilitated TF-CBT
arm group type: Experimental
description: Standard treatment with the addition of in-treatment/session iPad activities
intervention type: Behavioral
intervention name: TFCBT
description: treatment as usual
arm group label: Treatment as usual
intervention type: Behavioral
intervention name: eTFCBT
description: tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
arm group label: Tablet-Facilitated TF-CBT
criteria: 
gender: All
minimum age: 8 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic