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| Name | Class |
|---|---|
| The Israeli insurance companies organization | UNKNOWN |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual (TAU) | No Intervention | Participants recive Psycho-education and neuro-psycological diagnosis. | |
| Cognitive-Behavioral Therapy (CBT) | Experimental | Participants recive 16 sessions of CBT in addition to arm TAU treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy | Behavioral | 16 Sessions of CBT. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maayan Shorer, PhD. | Contact | +972523402547 | maayans@clalit.org.il | |
| Irit Aviv, M.A. | Contact | +972546416316 | irita161@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Orit Krispin, PhD | Schneider Childrens' Medical Center of Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Childrens' Medical Center of Israel | Recruiting | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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. |
| D009422 |
| Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |