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

NCT ID: NCT02475044

Last Updated: 2016-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Post-Concussion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Treatment as usual (TAU)

Participants recive Psycho-education and neuro-psycological diagnosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Cognitive-Behavioral Therapy (CBT)

Participants recive 16 sessions of CBT in addition to arm TAU treatment.

Group Type EXPERIMENTAL

Cognitive-Behavioral Therapy

Intervention Type BEHAVIORAL

16 Sessions of CBT.

Interventions

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Cognitive-Behavioral Therapy

16 Sessions of CBT.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* mental retardation.
* drug abuse.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Israeli insurance companies organization

UNKNOWN

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orit Krispin, PhD

Role: PRINCIPAL_INVESTIGATOR

Schneider Childrens' Medical Center of Israel

Locations

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Schneider Childrens' Medical Center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Maayan Shorer, PhD.

Role: CONTACT

+972523402547

Irit Aviv, M.A.

Role: CONTACT

+972546416316

Facility Contacts

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Maayan Shorer, PhD

Role: primary

+97239253864

Other Identifiers

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0439-14

Identifier Type: -

Identifier Source: org_study_id

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