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

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?

Study Overview

• Status: Unknown
• Conditions: Post-Concussion Syndrome
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy

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
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maayan Shorer, PhD.; Phone Number: +972523402547; Email: maayans@clalit.org.il
• Study Contact Backup: Name: Irit Aviv, M.A.; Phone Number: +972546416316; Email: irita161@gmail.com

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Schneider Childrens' Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• mental retardation.
• drug abuse.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: CBT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Change from Baseline in the Childrens Depression Inventory at Treatment Completion	Childrens Depression Inventory, Kovacs, 1992	Approximately 9 months since injury.
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.
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.

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: The Israeli insurance companies organization
• Investigators: Principal Investigator: Orit Krispin, PhD, Schneider Childrens' Medical Center of Israel

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (ESTIMATE): June 18, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 9, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: parenting; post-concussion; Cognitive-Behavioral Theray
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 0439-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO