Clinical trial NCT02475044: Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
Official title: Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Concussion Syndrome
Keywords: post-concussion
Cognitive-Behavioral Theray
parenting
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: The Israeli insurance companies organization
First posted: 2015-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Head trauma.
* Post-concussive symptoms diagnosis according to DSMIV.

Exclusion Criteria:

* mental retardation.
* drug abuse.

Primary outcomes:
measure: Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
timeFrame: Approximately 9 months since injury.
Secondary outcomes:
measure: Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
timeFrame: Approximately 9 months since injury.
measure: Change from Baseline in the Childrens Depression Inventory at Treatment Completion
timeFrame: Approximately 9 months since injury.
measure: Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
timeFrame: Approximately 9 months since injury.
measure: 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.
timeFrame: Approximately 9 months since injury.
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Childrens' Medical Center of Israel
Study officials:
affiliation: Schneider Childrens' Medical Center of Israel
name: Orit Krispin, PhD
role: PRINCIPAL_INVESTIGATOR
References: