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

Post-Concussion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02475044
• Other study ID #: 0439-14
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2015
• Last updated: October 9, 2016
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: October 2016
• Source: Rabin Medical Center
• Contact: Maayan Shorer, PhD.
• Phone: +972523402547
• Email: maayans[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Head trauma.

• Post-concussive symptoms diagnosis according to DSMIV.

Exclusion Criteria:

• mental retardation.

• drug abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Post-Concussion Syndrome

Intervention

Behavioral:
• Cognitive-Behavioral Therapy
16 Sessions of CBT.

Locations

Country	Name	City	State
Israel	Schneider Childrens' Medical Center of Israel	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	The Israeli insurance companies organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Post Concussion Symptoms Scale at treatment completion.	PCI-I (Mittenberg, Miller & Luis, 1997)	Approximately 9 months since injury.	No
Secondary	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.	No
Secondary	Change from Baseline in the Childrens Depression Inventory at Treatment Completion	Childrens Depression Inventory, Kovacs, 1992	Approximately 9 months since injury.	No
Secondary	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.	No
Secondary	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.	No