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

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ClinicalTrials.gov Identifier: NCT02926677
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : September 23, 2019
Sponsor:
Collaborators:
Stanford Youth Solutions
Drexel University
Iowa State University
University of California, San Francisco
Information provided by (Responsible Party):
Victor G. Carrion, Stanford University

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.


Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Cue-Centered Treatment (CCT) Behavioral: Trauma-Focused CBT (TF-CBT) Behavioral: Treatment as Usual Device: NIRScout Not Applicable

Detailed Description:

The children will be referred from Stanford Youth Solutions and University of California, San Francisco. Caregivers will undergo a telephone screening according to the inclusion and exclusion criteria. Written consent for participation will be obtained from participants, parents and/or legal guardians. Participants will be randomly assigned to one of three treatment conditions: TF-CBT, CCT, or TAU. Assessments will be administered at 4 time points: 1) pre-treatment, 2) mid-therapy, 3) post-treatment, and 4) three month follow-up. A medical/developmental history form will be completed only pre-treatment. The UCLA PTSD Reaction Index (PTSD-RI) parent and child versions will be used to assess exposure to traumatic events and post-traumatic stress symptoms. Given that trauma has high comorbidity with depression and anxiety disorders these symptoms will be assessed using the Multidimensional Anxiety Scale for Children (MASC) and Children's Depression Inventory (CDI). Executive functioning will be assessed by both child and parent report using the Behavioral Rating Inventory of Executive Function (BRIEF).

In addition, functional near-infrared spectroscopy (fNIRs) will be conducted at each of these time points to assess tasks of working memory, response inhibition, and facial recognition. The investigators will be using the NIRScout which is a portable NIRS recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp, to enable the noninvasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: A Randomized Controlled Trial of Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and Treatment as Usual (TAU)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cue-Centered Treatment (CCT)
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)
Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.

Device: NIRScout
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.

Experimental: Trauma-Focused CBT (TF-CBT)
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)
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.

Device: NIRScout
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.

Experimental: Treatment as Usual (TAU)
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
The control group. The standard treatment utilized at Stanford Youth Solutions

Device: NIRScout
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.




Primary Outcome Measures :
  1. Change from Baseline in UCLA PTSD Reaction Index for DSM-V (self-report and caregiver report) [ Time Frame: Change from Baseline at session 7 (=mid-treatment), session 15 (=end treatment), and 3 months post-treatment ]
    The UCLA PTSD Reaction Index for DSM-V is a 31 item self-report measure with child and caregiver versions. It screens for exposure to traumatic events and assesses the frequency of occurrence of PTSD symptoms in the past month on a scale of 0-4 (caregivers also have the option of responding "I don't know to frequency of occurrence). The items map onto the DSM-V criteria for PTSD as well as assessing for dissociative subtype.


Secondary Outcome Measures :
  1. Change from Baseline in Children's Depression Inventory (CDI 2) [ Time Frame: Change from Baseline at session 7 (=mid-treatment), session 15 (=end treatment), and 3 months post-treatment ]
    The CDI 2 is a 28 item self-report measure that assesses depressive symptoms in the past two weeks. A total score is obtained as well as scores for subscales of negative mood, negative self-esteem, interpersonal problems, anhedonia, and ineffectiveness.T-scores of 65 and above are considered within clinical range.

  2. Change from Baseline in Multidimensional Anxiety Scale for Children (MASC 2) [ Time Frame: Change from Baseline at session 7 (=mid-treatment), session 15 (=end treatment), and 3 months post-treatment ]
    The MASC 2 is a 50 item self-report measure assessing anxiety on a scale of 0-3. It obtains a total score and anxiety probability score as well as scales for separation anxiety/phobias, social anxiety, generalized anxiety index, OCD, physical symptoms and harm avoidance. There is also a measure for inconsistency in responses. T-scores of 65 and above are considered in the clinical range.

  3. Change from Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (self-report and caregiver report) [ Time Frame: Change from Baseline at session 7 (=mid-treatment), session 15 (=end treatment), and 3 months post-treatment ]
    The BRIEF is an 80 item measure (86 for caregivers) that assesses impairment in executive function with symptoms rated as occurring "Never," "Sometimes," or "Often." There are 8 clinical scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). The clinical scales form two broader Indexes (Behavioral Regulation and Metacognition) and an overall score, the Global Executive Composite. T-scores of 65 and above are considered in the clinical range.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Low cognitive functioning (IQ less than 70)
  2. Substance dependence as defined by DSM criteria
  3. Autism/Schizophrenia
  4. Clinically significant medical illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926677


Contacts
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Contact: Cynthia Marquez Miranda, MA 916-344-0199 cmarquezmiranda@stanford.edu

Locations
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United States, California
Stanford Youth Solutions Recruiting
Sacramento, California, United States, 95826
Contact: Cynthia Miranda    916-344-0199 ext 213    cmarquezmiranda@stanford.edu   
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94110
Contact: William Martinez, PhD    415-206-4444    william.martinez@ucsf.edu   
Sponsors and Collaborators
Stanford University
Stanford Youth Solutions
Drexel University
Iowa State University
University of California, San Francisco
Investigators
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Principal Investigator: Victor G Carrion, M.D. Stanford University
Study Director: Hilit Kletter, PhD Stanford University
Study Director: Flint Espil, PhD Stanford Univeristy

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Responsible Party: Victor G. Carrion, Professor-Med CTR LIne, Stanford University
ClinicalTrials.gov Identifier: NCT02926677     History of Changes
Other Study ID Numbers: 36092
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Victor G. Carrion, Stanford University:
PTSD
Child Trauma
Cue-Centered Treatment
Trauma-Focused Cognitive-Behavioral Therapy
fNIRs
CCT
TF-CBT
Posttraumatic stress
NIRX
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders