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

NCT02926677 | Completed Results

• 1 other identifier: 36092
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Child Trauma; Cue-Centered Treatment; Trauma-Focused Cognitive-Behavioral Therapy; fNIRs; CCT; TF-CBT; Posttraumatic stress; NIRX

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report)

  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.

  Baseline and month 3 (end of treatment)

• Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report)

  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.

  Baseline and month 3 (end of treatment)

Secondary Outcomes (3)

• Change From Baseline in Children's Depression Inventory (CDI 2)

  Baseline and month 3 (end of treatment)

• Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)

  Baseline and month 3 (end of treatment)

• Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)

  Baseline to month 3 (end of treatment)

Study Arms (3)

Cue-Centered Therapy (CCT)

EXPERIMENTAL

Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)

Behavioral: Cue-Centered Treatment (CCT); Device: NIRScout

Trauma-Focused CBT (TF-CBT)

EXPERIMENTAL

Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)

Behavioral: Trauma-Focused CBT (TF-CBT); Device: NIRScout

Treatment as Usual (TAU)

EXPERIMENTAL

TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)

Behavioral: Treatment as Usual; Device: NIRScout

Interventions

Cue-Centered Treatment (CCT) BEHAVIORAL

Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.

Cue-Centered Therapy (CCT)

Trauma-Focused CBT (TF-CBT) BEHAVIORAL

Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.

Trauma-Focused CBT (TF-CBT)

Treatment as Usual BEHAVIORAL

The control group. The standard treatment utilized at Stanford Youth Solutions

Treatment as Usual (TAU)

NIRScout DEVICE

The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.

Cue-Centered Therapy (CCT); Trauma-Focused CBT (TF-CBT); Treatment as Usual (TAU)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Low cognitive functioning (IQ less than 70)
• Substance dependence as defined by DSM criteria
• Autism/Schizophrenia
• Clinically significant medical illness

Sponsors & Collaborators

• Stanford University: lead
• Stanford Youth Solutions: collaborator
• Drexel University: collaborator
• Iowa State University: collaborator
• University of California, San Francisco: collaborator

Study Sites (2)

Stanford Youth Solutions

Sacramento, California, 95826, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

The study was underpowered because the number of participants with analyzable data did not meet the threshold for the planned analysis.

Results Point of Contact

• Title: Hilit Kletter
• Organization: Stanford University

hkletter@stanford.edu

650-723-5511

Study Officials

• Victor G Carrion, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

• Hilit Kletter, PhD

  Stanford University

  STUDY DIRECTOR

• Flint Espil, PhD

  Stanford Univeristy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Med CTR LIne

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: January 1, 2017
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)