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

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ClinicalTrials.gov Identifier: NCT02475044
Recruitment Status : Unknown
Verified October 2016 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : June 18, 2015
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
The Israeli insurance companies organization
Information provided by (Responsible Party):
Rabin Medical Center

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?

Condition or disease Intervention/treatment Phase
Post-Concussion Syndrome Behavioral: Cognitive-Behavioral Therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. Change from Baseline in the Childrens Depression Inventory at Treatment Completion [ Time Frame: Approximately 9 months since injury. ]
    Childrens Depression Inventory, Kovacs, 1992

  3. 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)

  4. 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



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • mental retardation.
  • drug abuse.

Information from the National Library of Medicine

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


Contacts
Contact: Maayan Shorer, PhD. +972523402547 maayans@clalit.org.il
Contact: Irit Aviv, M.A. +972546416316 irita161@gmail.com

Locations
Israel
Schneider Childrens' Medical Center of Israel Recruiting
Petach Tikva, Israel
Contact: Maayan Shorer, PhD    +97239253864    maayans@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
The Israeli insurance companies organization
Investigators
Principal Investigator: Orit Krispin, PhD Schneider Childrens' Medical Center of Israel

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02475044     History of Changes
Other Study ID Numbers: 0439-14
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rabin Medical Center:
post-concussion
Cognitive-Behavioral Theray
parenting

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Post-Concussion Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating