Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
1 other identifier
interventional
200
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 11, 2016
October 1, 2016
3 years
June 8, 2015
October 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
PCI-I (Mittenberg, Miller \& Luis, 1997)
Approximately 9 months since injury.
Secondary Outcomes (4)
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
Approximately 9 months since injury.
Change from Baseline in the Childrens Depression Inventory at Treatment Completion
Approximately 9 months since injury.
Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
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.
Approximately 9 months since injury.
Study Arms (2)
Treatment as usual (TAU)
NO INTERVENTIONParticipants recive Psycho-education and neuro-psycological diagnosis.
Cognitive-Behavioral Therapy (CBT)
EXPERIMENTALParticipants recive 16 sessions of CBT in addition to arm TAU treatment.
Interventions
16 Sessions of CBT.
Eligibility Criteria
You may qualify if:
- Head trauma.
- Post-concussive symptoms diagnosis according to DSMIV.
You may not qualify if:
- mental retardation.
- drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- The Israeli insurance companies organizationcollaborator
Study Sites (1)
Schneider Childrens' Medical Center of Israel
Petah Tikva, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Orit Krispin, PhD
Schneider Childrens' Medical Center of Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 18, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
October 11, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share