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

NCT ID: NCT02926677

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-04-24

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cue-Centered Therapy (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)

Group Type: EXPERIMENTAL

Cue-Centered Treatment (CCT)

Intervention Type: BEHAVIORAL

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

NIRScout

Intervention Type: 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.

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)

Group Type: EXPERIMENTAL

Trauma-Focused CBT (TF-CBT)

Intervention Type: 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.

NIRScout

Intervention Type: 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.

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)

Group Type: EXPERIMENTAL

Treatment as Usual

Intervention Type: BEHAVIORAL

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

NIRScout

Intervention Type: 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.

Interventions

Cue-Centered Treatment (CCT)

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Treatment as Usual

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford Youth Solutions

OTHER

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: collaborator

Iowa State University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Victor G. Carrion

Professor-Med CTR LIne

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor G Carrion, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Hilit Kletter, PhD

Role: STUDY_DIRECTOR

Stanford University

Flint Espil, PhD

Role: STUDY_DIRECTOR

Stanford Univeristy

Locations

Stanford Youth Solutions

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

36092

Identifier Type: -

Identifier Source: org_study_id