Post Traumatic Stress DisorderNCT03305458
Improving Quality of Care in Child Mental Health Service Settings
A study testing TFCBT and eTFCBT in people with Post Traumatic Stress Disorder and Technology, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Technology, Child Abuse
- What is being tested?
- TFCBT and eTFCBT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 713 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Technology, Child Abuse
- Being tested
- TFCBT, eTFCBT
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFCBTBehavioural
treatment as usual
eTFCBTBehavioural
tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Trauma Focused Cognitive Behavioral Therapy Receives: Behavioral: TFCBT |
| Tablet-Facilitated TF-CBT | Experimental | Standard treatment with the addition of in-treatment/session iPad activities Receives: Behavioral: eTFCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 Month Timeline
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 Oct 2018
- Primary completion27 Feb 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305458
- Sponsor's protocol ID
- R01MH110620
- Status last verified
- May 2025
- First submitted
- 4 Oct 2017
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care in Child Mental Health Service Settings
- ClinicalTrials.gov ID
- NCT03305458
- Acronym / sponsor ID
- R01MH110620
- Conditions
- Post Traumatic Stress Disorder, Technology, Child Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: TFCBTTrauma Focused Cognitive Behavioral Therapy |
| Tablet-Facilitated TF-CBT | Experimental | Behavioral: eTFCBTStandard treatment with the addition of in-treatment/session iPad activities |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFCBTtreatment as usual | Behavioural | Treatment as usual |
| eTFCBTtablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT) | Behavioural | Tablet-Facilitated TF-CBT |
Primary outcome
Child Involvement Ratings Scale (CIRS)
Time frame: 3 Month Timeline
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.
Provider Treatment Fidelity (TPOCS)
Time frame: 3 Month Timeline
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.
19 secondary outcomes
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Therapeutic Alliance Scale for Children (TASC)
Time frame: 3 Month
Child/Adolescent Satisfaction Questionnaire (CASQ).
Time frame: 3 Month
The Shame Measure
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
The Child and Adolescent Trauma Screen (CATS) - Youth Version
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Caregiver Satisfaction Questionnaire (CSQ)
Time frame: 3 Month
Working Alliance Inventory (WAI-short Form)
Time frame: 3 Month Timeline
Brief Problems Monitor (BPM)
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Center for Epidemiologic Studies Depression Scale (CESD-R).
Time frame: baseline, 3, 6, 9, 12 months Timeline
The Child and Adolescent Trauma Screen (CATS) - Caregiver Version
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
The Alabama Parenting Questionnaire
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
The Kessler 6
Time frame: Baseline, 3 Month, 6 Month, 9 Month, 12 Month
Evidence-Based Practice Attitude Scale (EBPAS)
Time frame: baseline, post baseline at 12 Months
Knowledge of Behavioral Principles as Applied to Children
Time frame: Baseline, Post Baseline at 12 months
Acceptability, Appropriateness and Feasibility Measure (AIMIAMFIM)
Time frame: baseline, Post baseline at 12 months
Computer Assisted Therapy Attitudes Scale
Time frame: baseline, post baseline at 12 months
Organizational Readiness for Implementing Change
Time frame: baseline, post baseline at 12 months
TF-CBT Organizational Support Measure
Time frame: baseline, post baseline at 12 month
Burnout Measure
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFCBT and eTFCBT in people with Post Traumatic Stress Disorder and Technology, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Involvement Ratings Scale (CIRS) (time frame: 3 Month Timeline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.