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

Not Applicable

• Conditions: Post-Concussion Syndrome
• Interventions: Behavioral: Cognitive-Behavioral Therapy

• Registration Number: NCT02475044
• Lead Sponsor: 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?

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-18
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-09
• Last Update Posted: 2016-10-11
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• mental retardation.
• drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy (CBT)	Cognitive-Behavioral Therapy	Participants recive 16 sessions of CBT in addition to arm TAU treatment.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Post Concussion Symptoms Scale at treatment completion.	Approximately 9 months since injury.	PCI-I (Mittenberg, Miller \& Luis, 1997)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion	Approximately 9 months since injury.	The State-Trait Anxiety Inventory for Children, Spielberger et al.
Change from Baseline in the Childrens Depression Inventory at Treatment Completion	Approximately 9 months since injury.	Childrens Depression Inventory, Kovacs, 1992
Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion	Approximately 9 months since injury.	The Child PTSD Symptoms Scale (Foa et al., 2001)
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.	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

Trial Locations

Locations (1)

Schneider Childrens' Medical Center of Israel; 🇮🇱 Petach Tikva, Israel