Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02475044
Enrollment
200
Registered
2015-06-18
Start date
2015-06-30
Completion date
2018-06-30
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Concussion Syndrome

Keywords

post-concussion, Cognitive-Behavioral Theray, parenting

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.

Interventions

BEHAVIORALCognitive-Behavioral Therapy

16 Sessions of CBT.

Sponsors

The Israeli insurance companies organization
CollaboratorUNKNOWN
Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* mental retardation. * drug abuse.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment CompletionApproximately 9 months since injury.The State-Trait Anxiety Inventory for Children, Spielberger et al.
Change from Baseline in the Childrens Depression Inventory at Treatment CompletionApproximately 9 months since injury.Childrens Depression Inventory, Kovacs, 1992
Change from Baseline in The Child PTSD Symptoms Scale at Treatment CompletionApproximately 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

Countries

Israel

Contacts

Primary ContactMaayan Shorer, PhD.
maayans@clalit.org.il+972523402547
Backup ContactIrit Aviv, M.A.
irita161@gmail.com+972546416316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026