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 un
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
Group
Value
95% CI
Treatment as Usual
.50
± .21
Tablet-Facilitated TF-CBT
.43
± .24
Center for Epidemiological Studies Depression Scale for Children (CES-DC)Secondary· Baseline, 3 Month, 6 Month, 9 Month, 12 Month
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 Timeline
Group
Value
95% CI
Treatment as Usual
25.21
± 12.32
Tablet-Facilitated TF-CBT
23.61
± 11.86
3 Month Timeline
Group
Value
95% CI
Treatment as Usual
20.88
± 11.44
Tablet-Facilitated TF-CBT
20.66
± 11.92
6 Month Timeline
Group
Value
95% CI
Treatment as Usual
19.22
± 9.88
Tablet-Facilitated TF-CBT
18.91
± 10.21
9 Month Timeline
Group
Value
95% CI
Treatment as Usual
18.35
± 9.35
Tablet-Facilitated TF-CBT
19.33
± 10.73
12 Month Timeline
Group
Value
95% CI
Treatment as Usual
16
± 10.02
Tablet-Facilitated TF-CBT
18.76
± 11.152
Therapeutic Alliance Scale for Children (TASC)Secondary· 3 Month
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 ra
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.
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 Timeline
Group
Value
95% CI
Treatment as Usual
2.40
± 2.23
Tablet-Facilitated TF-CBT
2.08
± 2.23
3 Month Timeline
Group
Value
95% CI
Treatment as Usual
1.58
± 1.77
Tablet-Facilitated TF-CBT
1.54
± 2.01
6 Month Timeline
Group
Value
95% CI
Treatment as Usual
1.34
± 1.77
Tablet-Facilitated TF-CBT
1.34
± 1.94
9 Month Timeline
Group
Value
95% CI
Treatment as Usual
1.21
± 1.60
Tablet-Facilitated TF-CBT
1.07
± 1.71
12 Month Timeline
Group
Value
95% CI
Treatment as Usual
1.02
± 1.81
Tablet-Facilitated TF-CBT
1.14
± 1.78
The Child and Adolescent Trauma Screen (CATS) - Youth VersionSecondary· Baseline, 3 Month, 6 Month, 9 Month, 12 Month
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.
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. Sc
Group
Value
95% CI
Treatment as Usual
52.46
± 7.64
Tablet-Facilitated TF-CBT
52.79
± 8.67
Working Alliance Inventory (WAI-short Form)Secondary· 3 Month Timeline
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.
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 Timeline
Group
Value
95% CI
Treatment as Usual
14.5
± 7.78
Tablet-Facilitated TF-CBT
14.9
± 7.62
3 Month Timeline
Group
Value
95% CI
Treatment as Usual
12.1
± 8.07
Tablet-Facilitated TF-CBT
13.3
± 8.48
6 Month Timeline
Group
Value
95% CI
Treatment as Usual
10.6
± 8.94
Tablet-Facilitated TF-CBT
12.7
± 8.74
9 Month Timeline
Group
Value
95% CI
Treatment as Usual
11.0
± 8.99
Tablet-Facilitated TF-CBT
12.1
± 9.00
12 Month Timeline
Group
Value
95% CI
Treatment as Usual
9.8
± 8.99
Tablet-Facilitated TF-CBT
11.9
± 7.97
Center for Epidemiologic Studies Depression Scale (CESD-R).Secondary· baseline, 3, 6, 9, 12 months Timeline
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 enr
Baseline
Group
Value
95% CI
Treatment as Usual
17.94
± 14.59
Tablet-Facilitated TF-CBT
18.28
± 13.25
3 Month Timeline
Group
Value
95% CI
Treatment as Usual
14.77
± 13.71
Tablet-Facilitated TF-CBT
16.23
± 12.61
6 Month Timeline
Group
Value
95% CI
Treatment as Usual
12.94
± 12.99
Tablet-Facilitated TF-CBT
23.88
± 86.44
9 Month Timeline
Group
Value
95% CI
Treatment as Usual
14.6
± 12.80
Tablet-Facilitated TF-CBT
15.62
± 13.87
12 Month Timeline
Group
Value
95% CI
Treatment as Usual
12.66
± 12.90
Tablet-Facilitated TF-CBT
14.91
± 13.49
The Child and Adolescent Trauma Screen (CATS) - Caregiver VersionSecondary· Baseline, 3 Month, 6 Month, 9 Month, 12 Month
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 poi
Baseline
Group
Value
95% CI
Treatment as Usual
21.16
± 12.64
Tablet-Facilitated TF-CBT
20.27
± 12.65
3 Month
Group
Value
95% CI
Treatment as Usual
13.80
± 11.43
Tablet-Facilitated TF-CBT
16.70
± 12.26
6 Month
Group
Value
95% CI
Treatment as Usual
13.95
± 12.57
Tablet-Facilitated TF-CBT
13.85
± 12.09
9 Month
Group
Value
95% CI
Treatment as Usual
13.62
± 13.92
Tablet-Facilitated TF-CBT
13.80
± 12.23
12 Month
Group
Value
95% CI
Treatment as Usual
10.22
± 12.37
Tablet-Facilitated TF-CBT
12.92
± 12.06
Adverse events — posted to ClinicalTrials.gov
Time frame: 52 weeks, 1 year.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03305458.