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

Stress Disorders, Post-Traumatic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926677
• Other study ID #: 36092
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: April 24, 2020

Study information

• Verified date: March 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Cue-Centered Treatment (CCT)
Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Stanford Youth Solutions	Sacramento	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Drexel University, Iowa State University, Stanford Youth Solutions, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change From Baseline in Children's Depression Inventory (CDI 2)	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.	Baseline and month 3 (end of treatment)
Secondary	Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)	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.	Baseline and month 3 (end of treatment)
Secondary	Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)	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 gets converted to a T-score with T-scores of 65 or above considered in the clinical range.	Baseline to month 3 (end of treatment)