Adults 7 to 18, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report)Primary· Baseline and month 3 (end of treatment)
The UCLA PTSD Reaction Index for DSM 5 is a 31 item self-report measure with child and caregiver versions. The total severity score ranging from 0-80 is obtained by summing the four symptom category sub-scales (criteria B, C, D, \& E). A higher score corresponds to greater PTSD severity. The items map onto the DSM 5 criteria for PTSD as well as assessing for dissociative subtype.
Group
Value
95% CI
Cue-Centered Treatment (CCT)
-13.3
± 12.1
Trauma-Focused CBT (TF-CBT)
-17.8
± 15.8
Treatment as Usual (TAU)
-9.8
± 10.2
Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report)Primary· Baseline and month 3 (end of treatment)
The UCLA PTSD Reaction Index for DSM 5 is a 31 item self-report measure with child and caregiver versions. Scores range from 0 to 80 (higher score indicates more sever PTSD symptoms). The items map onto the DSM-V criteria for PTSD as well as assessing for dissociative subtype.
Group
Value
95% CI
Cue-Centered Treatment (CCT)
-11.2
± 11.1
Trauma-Focused CBT (TF-CBT)
-17.4
± 16.1
Treatment as Usual (TAU)
-2.3
± 10.2
Change From Baseline in Children's Depression Inventory (CDI 2)Secondary· Baseline and month 3 (end of treatment)
The CDI 2 is a 28 item self-report measure that assesses depressive symptoms in the past two weeks. Each item is scored from 0-2 and all items are summed to obtain the total score (total score range: 0-54; a score of 19 or higher is suggestive of clinical depression). The survey contains questions related to negative mood, negative self-esteem, interpersonal problems, anhedonia, and ineffectiveness.
Group
Value
95% CI
Cue-Centered Treatment (CCT)
-3.6
± 7.3
Trauma-Focused CBT (TF-CBT)
-4.7
± 7.1
Treatment as Usual (TAU)
-6.0
± 9.6
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)Secondary· Baseline and month 3 (end of treatment)
The MASC 2 is a 50 item self-report measure assessing anxiety in the following sub-scales: separation anxiety/phobias, social anxiety, generalized anxiety, OCD, physical symptoms and harm avoidance. The total raw score is obtained by summing all the sub-scales. Total raw scores range from 0-150 with higher scores indicative of more severe anxiety. The raw score gets converted into a T-score interpreted as such: 45-55 average, 56-60 slightly above average, 61-65 above average, 66-70 much above average, and score of 70 or above is considered to be indicative of clinical anxiety.
Group
Value
95% CI
Cue-Centered Treatment (CCT)
-15.8
± 20.5
Trauma-Focused CBT (TF-CBT)
-12.8
± 11.2
Treatment as Usual (TAU)
-16.8
± 28.7
Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)Secondary· Baseline to month 3 (end of treatment)
The BRIEF is an 86 item measure that assesses impairment in executive function with symptoms rated on a likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). A Global Executive Composite score is obtained by summing all 8 clinical sub-scales. The Global Executive Composite ranges from 0-258 with higher scores indicating greater impairment in executive functions. The Global Executive Composite ge
Inhibit subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
2.22
± 1.72
Trauma-Focused CBT (TF-CBT)
0.44
± 4.25
Treatment as Usual (TAU)
-2.00
± 5.73
Shift subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
0.56
± 1.67
Trauma-Focused CBT (TF-CBT)
2.33
± 2.24
Treatment as Usual (TAU)
-0.83
± 4.36
Emotional Control subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
2.56
± 3.28
Trauma-Focused CBT (TF-CBT)
3.89
± 2.85
Treatment as Usual (TAU)
0.17
± 4.12
Initiate subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
1.11
± 3.14
Trauma-Focused CBT (TF-CBT)
1.11
± 2.71
Treatment as Usual (TAU)
1.17
± 2.64
Working memory subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
2.67
± 2.29
Trauma-Focused CBT (TF-CBT)
2.00
± 3.35
Treatment as Usual (TAU)
-0.33
± 4.23
Plan/Organize subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
1.78
± 3.03
Trauma-Focused CBT (TF-CBT)
2.22
± 5.45
Treatment as Usual (TAU)
-0.67
± 4.59
Organization of Materials subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
1.00
± 3.12
Trauma-Focused CBT (TF-CBT)
1.44
± 1.74
Treatment as Usual (TAU)
1.00
± 2.00
Monitor subscale
Group
Value
95% CI
Cue-Centered Therapy (CCT)
0.78
± 2.44
Trauma-Focused CBT (TF-CBT)
0.44
± 3.32
Treatment as Usual (TAU)
-2.17
± 5.46
Sponsor's own description
This study is designed to examine three treatment conditions for traumatized youth: Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and Treatment as Usual (TAU) to determine which treatment works most effectively for which youth. The investigators would like to determine feasibility of training on the treatment interventions. In addition, this study aims to inform development of systems of care for chronically traumatized youth.
The investigators hope to determine whether 1) TF-CBT and CCT will have better outcomes than TAU, 2) Child characteristics predict better outcome in either TF-CBT or CCT and to identify which phases of treatment are most effective, and 3) Imaging findings will be predictors of improved outcome. This research is important because while there are many existing trauma interventions for youth, little is known about what is most essential in those interventions. This study will shed light on what components of treatment are most effective. Furthermore, there are minimal guidelines on how to select the most appropriate intervention for a particular child. This study will contribute to that knowledge by informing which interventions are suited best for which youth.
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 Stanford University
Last refreshed: 8 April 2021
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/NCT02926677.