Clinical trial NCT02926677: Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: CCT, TF-CBT, TAU
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
Child Trauma
Cue-Centered Treatment
Trauma-Focused Cognitive-Behavioral Therapy
fNIRs
CCT
TF-CBT
Posttraumatic stress
NIRX
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Stanford Youth Solutions
name: Drexel University
name: Iowa State University
name: University of California, San Francisco
First posted: 2016-10-06
Enrollment: 73
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report)
timeFrame: Baseline and month 3 (end of treatment)
measure: Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report)
timeFrame: Baseline and month 3 (end of treatment)
Secondary outcomes:
measure: Change From Baseline in Children's Depression Inventory (CDI 2)
timeFrame: Baseline and month 3 (end of treatment)
measure: Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)
timeFrame: Baseline and month 3 (end of treatment)
measure: Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
timeFrame: Baseline to month 3 (end of treatment)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Stanford Youth Solutions
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Stanford University
name: Victor G Carrion, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Hilit Kletter, PhD
role: STUDY_DIRECTOR
affiliation: Stanford Univeristy
name: Flint Espil, PhD
role: STUDY_DIRECTOR
References: