Post-Concussion SyndromeNCT02475044
Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
A study testing Cognitive-Behavioral Therapy in people with Post-Concussion Syndrome, run by Rabin Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Head trauma.
- Post-concussive symptoms diagnosis according to DSMIV.
Who cannot join
- mental retardation.
- drug abuse.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Childrens' Medical Center of Israel
Petah Tikva
Maayan Shorer, PhD, +97239253864, maayans@clalit.org.il
About this study
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?
Read the 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.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Cognitive-Behavioral Therapy
- Keywords
- post-concussion, Cognitive-Behavioral Theray, parenting
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
Also called CBT
16 Sessions of CBT.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | Participants recive Psycho-education and neuro-psycological diagnosis. |
| Cognitive-Behavioral Therapy (CBT) | Experimental | Participants recive 16 sessions of CBT in addition to arm TAU treatment. Receives: Behavioral: Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
PCI-I (Mittenberg, Miller \& Luis, 1997)
Measured: Approximately 9 months since injury.
Secondary outcomes (4)
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
The State-Trait Anxiety Inventory for Children, Spielberger et al.
Measured: Approximately 9 months since injury.
Change from Baseline in the Childrens Depression Inventory at Treatment Completion
Childrens Depression Inventory, Kovacs, 1992
Measured: 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)
Measured: 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
Measured: Approximately 9 months since injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Israeli insurance companies organization
- Responsible party
- Sponsor
- Investigators
- Orit Krispin, PhD, Principal investigator, Schneider Childrens' Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475044
- Sponsor's protocol ID
- 0439-14
- Status last verified
- Oct 2016
- First submitted
- 8 Jun 2015
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits
- ClinicalTrials.gov ID
- NCT02475044
- Acronym / sponsor ID
- 0439-14
- Conditions
- Post-Concussion Syndrome
- Keywords
- post-concussion, Cognitive-Behavioral Theray, parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- The Israeli insurance companies organization
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | –Participants recive Psycho-education and neuro-psycological diagnosis. |
| Cognitive-Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive-Behavioral TherapyParticipants recive 16 sessions of CBT in addition to arm TAU treatment. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Head trauma.
- Post-concussive symptoms diagnosis according to DSMIV.
Key exclusion criteria (2 listed)
- mental retardation.
- drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral TherapyAlso: CBT16 Sessions of CBT. | Behavioural | Cognitive-Behavioral Therapy (CBT) |
Primary outcome
Change from baseline in the Post Concussion Symptoms Scale at treatment completion.
Time frame: Approximately 9 months since injury.
PCI-I (Mittenberg, Miller \& Luis, 1997)
4 secondary outcomes
Change from Baseline in The State-Trait Anxiety Inventory for Children at Treatment Completion
Time frame: Approximately 9 months since injury.
Change from Baseline in the Childrens Depression Inventory at Treatment Completion
Time frame: Approximately 9 months since injury.
Change from Baseline in The Child PTSD Symptoms Scale at Treatment Completion
Time frame: 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.
Time frame: Approximately 9 months since injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orit Krispin, PhD principal investigator
Schneider Childrens' Medical Center of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy in people with Post-Concussion Syndrome, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maayan Shorer, PhD. (+972523402547, maayans@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Post Concussion Symptoms Scale at treatment completion. (time frame: Approximately 9 months since injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.