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N/A N=73 Randomized Double-blind Treatment

Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: CCT, TF-CBT, TAU

Stress Disorders, Post-Traumatic

Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report) — -13.3; -17.8; -9.8 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cue-Centered Treatment (CCT) (Behavioral); Trauma-Focused CBT (TF-CBT) (Behavioral); Treatment as Usual (Behavioral); NIRScout (Device)
Age
Pediatric, Adult · 7+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Apr 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report)
-13.3; -17.8; -9.8
PRIMARY
Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report)
-11.2; -17.4; -2.3
SECONDARY
Change From Baseline in Children's Depression Inventory (CDI 2)
-3.6; -4.7; -6.0
SECONDARY
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)
-15.8; -12.8; -16.8
SECONDARY
Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
2.22; 0.44; -2.00; 0.56; 2.33; -0.83

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Exposure to at least one traumatic event and endorsement of any trauma symptoms on the UCLA PTSD Reaction Index for DSM-V
  • Ages 7-18
  • Willingness to participate in therapy and fNIRs imaging
  • Caregiver willing to participate in the study
  • Perpetrator of the traumatic event is not living in the home with the child

Exclusion Criteria

  • Low cognitive functioning (IQ less than 70)
  • Substance dependence as defined by DSM criteria
  • Autism/Schizophrenia
  • Clinically significant medical illness
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02926677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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