Trial Outcomes & Findings for Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: CCT, TF-CBT, TAU (NCT NCT02926677)
NCT ID: NCT02926677
Last Updated: 2021-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Baseline and month 3 (end of treatment)
Results posted on
2021-04-08
Participant Flow
Participant milestones
| Measure |
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
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)
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.
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.
|
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
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|---|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
26
|
|
Overall Study
COMPLETED
|
8
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: CCT, TF-CBT, TAU
Baseline characteristics by cohort
| Measure |
Cue-Centered Treatment (CCT)
n=25 Participants
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
Trauma-Focused CBT (TF-CBT)
n=22 Participants
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)
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.
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.
|
Treatment as Usual (TAU)
n=26 Participants
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.52 years
STANDARD_DEVIATION 3.00 • n=99 Participants
|
13.41 years
STANDARD_DEVIATION 3.29 • n=107 Participants
|
13.04 years
STANDARD_DEVIATION 3.05 • n=206 Participants
|
12.97 years
STANDARD_DEVIATION 3.09 • n=157 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
46 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
27 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
41 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
22 participants
n=107 Participants
|
26 participants
n=206 Participants
|
73 participants
n=157 Participants
|
|
UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (child self-report)
|
35.28 units on a scale
STANDARD_DEVIATION 15.66 • n=99 Participants
|
37.10 units on a scale
STANDARD_DEVIATION 15.53 • n=107 Participants
|
38.08 units on a scale
STANDARD_DEVIATION 14.04 • n=206 Participants
|
36.80 units on a scale
STANDARD_DEVIATION 14.90 • n=157 Participants
|
|
UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (parent report)
|
31.13 units on a scale
STANDARD_DEVIATION 16.01 • n=99 Participants
|
32.55 units on a scale
STANDARD_DEVIATION 13.73 • n=107 Participants
|
33.92 units on a scale
STANDARD_DEVIATION 15.61 • n=206 Participants
|
32.55 units on a scale
STANDARD_DEVIATION 15.02 • n=157 Participants
|
|
Multidimensional Anxiety Scale for Children (MASC 2)
|
63.76 units on a scale
STANDARD_DEVIATION 21.32 • n=99 Participants
|
58.70 units on a scale
STANDARD_DEVIATION 24.25 • n=107 Participants
|
59.56 units on a scale
STANDARD_DEVIATION 23.57 • n=206 Participants
|
60.64 units on a scale
STANDARD_DEVIATION 22.84 • n=157 Participants
|
|
Children's Depression Inventory (CDI 2)
|
17.38 units on a scale
STANDARD_DEVIATION 10.02 • n=99 Participants
|
18.29 units on a scale
STANDARD_DEVIATION 9.93 • n=107 Participants
|
17.42 units on a scale
STANDARD_DEVIATION 8.85 • n=206 Participants
|
17.68 units on a scale
STANDARD_DEVIATION 9.42 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Inhibit subscale
|
18.35 units on a scale
STANDARD_DEVIATION 5.71 • n=99 Participants
|
18.27 units on a scale
STANDARD_DEVIATION 5.95 • n=107 Participants
|
17.75 units on a scale
STANDARD_DEVIATION 4.99 • n=206 Participants
|
18.12 units on a scale
STANDARD_DEVIATION 5.47 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Shift subscale
|
15.87 units on a scale
STANDARD_DEVIATION 3.89 • n=99 Participants
|
15.64 units on a scale
STANDARD_DEVIATION 3.33 • n=107 Participants
|
15.87 units on a scale
STANDARD_DEVIATION 3.14 • n=206 Participants
|
15.80 units on a scale
STANDARD_DEVIATION 3.42 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Emotional Control subscale
|
21.26 units on a scale
STANDARD_DEVIATION 4.18 • n=99 Participants
|
21.45 units on a scale
STANDARD_DEVIATION 5.41 • n=107 Participants
|
20.50 units on a scale
STANDARD_DEVIATION 4.87 • n=206 Participants
|
21.06 units on a scale
STANDARD_DEVIATION 4.78 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Initiate subscale
|
15.65 units on a scale
STANDARD_DEVIATION 4.40 • n=99 Participants
|
16.77 units on a scale
STANDARD_DEVIATION 2.65 • n=107 Participants
|
16.79 units on a scale
STANDARD_DEVIATION 3.97 • n=206 Participants
|
16.41 units on a scale
STANDARD_DEVIATION 3.75 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Working Memory subscale
|
20.39 units on a scale
STANDARD_DEVIATION 5.32 • n=99 Participants
|
20.59 units on a scale
STANDARD_DEVIATION 5.00 • n=107 Participants
|
20.79 units on a scale
STANDARD_DEVIATION 4.95 • n=206 Participants
|
20.59 units on a scale
STANDARD_DEVIATION 5.02 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Plan/Organize subscale
|
22.65 units on a scale
STANDARD_DEVIATION 5.97 • n=99 Participants
|
25.23 units on a scale
STANDARD_DEVIATION 5.41 • n=107 Participants
|
23.96 units on a scale
STANDARD_DEVIATION 6.64 • n=206 Participants
|
23.93 units on a scale
STANDARD_DEVIATION 6.05 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Organization of Materials subscale
|
12.83 units on a scale
STANDARD_DEVIATION 3.77 • n=99 Participants
|
14.73 units on a scale
STANDARD_DEVIATION 2.75 • n=107 Participants
|
13.42 units on a scale
STANDARD_DEVIATION 3.65 • n=206 Participants
|
13.64 units on a scale
STANDARD_DEVIATION 3.47 • n=157 Participants
|
|
Behavior Rating Inventory of Executive Function (parent report) (BRIEF)
Monitor subscale
|
15.61 units on a scale
STANDARD_DEVIATION 3.96 • n=99 Participants
|
16.32 units on a scale
STANDARD_DEVIATION 4.22 • n=107 Participants
|
16.08 units on a scale
STANDARD_DEVIATION 3.69 • n=206 Participants
|
16.00 units on a scale
STANDARD_DEVIATION 3.91 • n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline and month 3 (end of treatment)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.
Outcome measures
| Measure |
Cue-Centered Treatment (CCT)
n=8 Participants
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
Trauma-Focused CBT (TF-CBT)
n=8 Participants
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)
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.
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.
|
Treatment as Usual (TAU)
n=6 Participants
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
|
|---|---|---|---|
|
Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report)
|
-13.3 score on a scale
Standard Deviation 12.1
|
-17.8 score on a scale
Standard Deviation 15.8
|
-9.8 score on a scale
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: Baseline and month 3 (end of treatment)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.
Outcome measures
| Measure |
Cue-Centered Treatment (CCT)
n=8 Participants
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
Trauma-Focused CBT (TF-CBT)
n=8 Participants
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)
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.
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.
|
Treatment as Usual (TAU)
n=6 Participants
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
|
|---|---|---|---|
|
Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report)
|
-11.2 score on a scale
Standard Deviation 11.1
|
-17.4 score on a scale
Standard Deviation 16.1
|
-2.3 score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline and month 3 (end of treatment)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.
Outcome measures
| Measure |
Cue-Centered Treatment (CCT)
n=8 Participants
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
Trauma-Focused CBT (TF-CBT)
n=8 Participants
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)
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.
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.
|
Treatment as Usual (TAU)
n=6 Participants
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
|
|---|---|---|---|
|
Change From Baseline in Children's Depression Inventory (CDI 2)
|
-3.6 score on a scale
Standard Deviation 7.3
|
-4.7 score on a scale
Standard Deviation 7.1
|
-6.0 score on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline and month 3 (end of treatment)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.
Outcome measures
| Measure |
Cue-Centered Treatment (CCT)
n=8 Participants
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
Trauma-Focused CBT (TF-CBT)
n=8 Participants
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)
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.
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.
|
Treatment as Usual (TAU)
n=6 Participants
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
|
|---|---|---|---|
|
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)
|
-15.8 score on a scale
Standard Deviation 20.5
|
-12.8 score on a scale
Standard Deviation 11.2
|
-16.8 score on a scale
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: Baseline to month 3 (end of treatment)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.
Outcome measures
| Measure |
Cue-Centered Treatment (CCT)
n=8 Participants
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)
Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
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.
|
Trauma-Focused CBT (TF-CBT)
n=8 Participants
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)
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.
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.
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Treatment as Usual (TAU)
n=6 Participants
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)
Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions
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.
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Inhibit subscale
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2.22 score on a scale
Standard Deviation 1.72
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0.44 score on a scale
Standard Deviation 4.25
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-2.00 score on a scale
Standard Deviation 5.73
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Shift subscale
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0.56 score on a scale
Standard Deviation 1.67
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2.33 score on a scale
Standard Deviation 2.24
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-0.83 score on a scale
Standard Deviation 4.36
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Emotional Control subscale
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2.56 score on a scale
Standard Deviation 3.28
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3.89 score on a scale
Standard Deviation 2.85
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0.17 score on a scale
Standard Deviation 4.12
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Initiate subscale
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1.11 score on a scale
Standard Deviation 3.14
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1.11 score on a scale
Standard Deviation 2.71
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1.17 score on a scale
Standard Deviation 2.64
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Working memory subscale
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2.67 score on a scale
Standard Deviation 2.29
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2.00 score on a scale
Standard Deviation 3.35
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-0.33 score on a scale
Standard Deviation 4.23
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Plan/Organize subscale
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1.78 score on a scale
Standard Deviation 3.03
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2.22 score on a scale
Standard Deviation 5.45
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-0.67 score on a scale
Standard Deviation 4.59
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Organization of Materials subscale
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1.00 score on a scale
Standard Deviation 3.12
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1.44 score on a scale
Standard Deviation 1.74
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1.00 score on a scale
Standard Deviation 2.00
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Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Monitor subscale
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0.78 score on a scale
Standard Deviation 2.44
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0.44 score on a scale
Standard Deviation 3.32
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-2.17 score on a scale
Standard Deviation 5.46
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Adverse Events
Cue-Centered Treatment (CCT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trauma-Focused CBT (TF-CBT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place