Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
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|ClinicalTrials.gov Identifier: NCT02475044|
Recruitment Status : Recruiting
First Posted : June 18, 2015
Last Update Posted : October 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post-Concussion Syndrome||Behavioral: Cognitive-Behavioral Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
No Intervention: Treatment as usual (TAU)
Participants recive Psycho-education and neuro-psycological diagnosis.
Experimental: Cognitive-Behavioral Therapy (CBT)
Participants recive 16 sessions of CBT in addition to arm TAU treatment.
Behavioral: Cognitive-Behavioral Therapy
16 Sessions of CBT.
Other Name: CBT
- Change from baseline in the Post Concussion Symptoms Scale at treatment completion. [ Time Frame: Approximately 9 months since injury. ]PCI-I (Mittenberg, Miller & Luis, 1997)
- Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion [ Time Frame: Approximately 9 months since injury. ]The State-Trait Anxiety Inventory for Children, Spielberger et al.
- Change from Baseline in the Childrens Depression Inventory at Treatment Completion [ Time Frame: Approximately 9 months since injury. ]Childrens Depression Inventory, Kovacs, 1992
- Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion [ Time Frame: Approximately 9 months since injury. ]The Child PTSD Symptoms Scale (Foa et al., 2001)
- Change from Baseline in Neuropsychological Functioning at Treatment Subjects will take paper and pencil and computer tests to evaluate memory, learning, attention and concentration, vocabulary and naming. [ Time Frame: Approximately 9 months since injury. ]The neuropsychological testing battery includes: Raven's Progressive Matrices, BRIEF, WISC-III-Hebrew Version (Digit Span), CMS (Spatial Span), D-KEFS (Design Fluency, Sorting Test, Trails Making Test), CPT, Stroop,TOMM Effort validity test, The Connors Rating Scale- Revised Long version
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): NCT02475044
|Contact: Maayan Shorer, PhD.||+firstname.lastname@example.org|
|Contact: Irit Aviv, M.A.||+email@example.com|
|Schneider Childrens' Medical Center of Israel||Recruiting|
|Petach Tikva, Israel|
|Contact: Maayan Shorer, PhD +97239253864 firstname.lastname@example.org|
|Principal Investigator:||Orit Krispin, PhD||Schneider Childrens' Medical Center of Israel|