Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits

Study Overview
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Brief Summary
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The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral symptoms?

Detailed Description
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200 children and adolescents with post concussion will be followed for 9 months, since the time of the head injury. Post concussive symptoms, along emotional distress and neurocognitive deficits will be examined at 2 weeks, 4 months and 9 months since the injury, using self report questionnaires, psychological evaluation and neuropsychological tests. Participants who demonstrates PPCS 4 months after the injury will be assigned either to the Cognitive Behavioral Treatmet group (CBT) or to the Treatment as Ususal group(TAU). The change in symptoms severity (PCS, emotional distress and neurocognitive deficits) will be compared between the two study groups in order to assess treatment efficacy.

Official Title
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Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits

Conditions
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Post-Concussion Syndrome

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head trauma. Post-concussive symptoms diagnosis according to DSMIV. Exclusion Criteria: mental retardation. drug abuse.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual (TAU)<br>Participants recive Psycho-education and neuro-psycological diagnosis. | |
| Experimental: Cognitive-Behavioral Therapy (CBT)<br>Participants recive 16 sessions of CBT in addition to arm TAU treatment. | Behavioral: Cognitive-Behavioral Therapy<br>* 16 Sessions of CBT.<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Post Concussion Symptoms Scale at treatment completion. | PCI-I (Mittenberg, Miller & Luis, 1997) | Approximately 9 months since injury. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion | The State-Trait Anxiety Inventory for Children, Spielberger et al. | Approximately 9 months since injury. | 
| Change from Baseline in the Childrens Depression Inventory at Treatment Completion | Childrens Depression Inventory, Kovacs, 1992 | Approximately 9 months since injury. | 
| Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion | The Child PTSD Symptoms Scale (Foa et al., 2001) | Approximately 9 months since injury. | 
| 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. | 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 | Approximately 9 months since injury. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-concussion, Cognitive-Behavioral Theray, parenting