Traumatic Brain Injury (TBI)AIMNCT01779427
Attention Intervention Management
A study testing AIM in people with Traumatic Brain Injury (TBI) and Attention Deficit Hyperactivity Disorder (ADHD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This is a research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Traumatic Brain Injury (TBI), Attention Deficit Hyperactivity Disorder (ADHD), Head Injury
- What is being tested?
- AIM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ages 10-18
- significant evidence of attentional impairments
- moderate to severe TBI
- time since injury at least 6 months
- completion of inpatient rehabilitation (if needed
- English as the primary spoken language in the home.
Who cannot join
- Child does not live with parents or guardian
- Child or parent has history of hospitalization for psychiatric problem
- TBI is a result of child abuse
- Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
- Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management
This is a research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury.
Read the detailed description
Impairments in attention are among the symptoms most frequently reported by parents and teachers following pediatric traumatic brain injury (TBI_. These cognitive disabilities are responsible for a wide range of academic and adjustment issues. Broadly defined, attention encompasses all of the mental processes, operations, and systems requisite for acquiring and applying information. It interacts with other cognitive functions including perception, memory/learning, organization, and reasoning; attention is core to the integration of those systems. A number of different attentional subcomponents with interconnected neural systems have been identified and shown to be differentially disrupted following trauma and other brain disorders, including maintenance or sustained attention, attentional selectivity, attentional capacity, and ability to effectively shift attention. Given the prevalence of attention difficulties and secondary attention deficit hyperactivity disorder (ADHD) following TBI, it is imperative to identify treatments to effectively address attention impairments.
The study will develop and pilot the Attention Intervention and Management program (AIM). AIM focuses on direct attention training in conjunction with metacognitive strategy training. Strategies are designed to improve focus and self regulation, reduce distractions, and enhance problem solving in academic settings. Integration of attention training and metacognitive strategies will help to ensure that the student can apply the skills across settings and situations.
The Randomized Controlled Trial (RCT) in Phase 2 of this project will address two interrelated hypotheses:
Hypothesis 1: Children receiving the Attention Intervention and Management (AIM) program will evidence better performance on standardized tests of attention and executive functions (EF) than those in the wait list control (WLC) group.
Hypothesis 2: Children receiving AIM will have fewer attention and EF problems than those in the WLC on parent and teacher rating scales of attention and EF.
Participants will include children ages 10-18 with significant evidence of attentional impairments.
- Conditions
- Traumatic Brain Injury (TBI), Attention Deficit Hyperactivity Disorder (ADHD), Head Injury, Brain Concussion, Head Injuries, Closed
- Being tested
- AIM
- Keywords
- traumatic brain injury (TBI), intracranial edema, brain edema, craniocerebral trauma, head injury, brain hemorrhage, traumatic, subdural hematoma, brain concussion, head injuries, closed, epidural hematoma, extra-axial hemorrhage, cortical contusion, wounds and injuries, disorders of environmental origin, trauma, nervous system, brain injuries, attention deficit hyperactivity disorder (ADHD), attention
- Medical subject headings
- Brain Injuries, Traumatic, Attention Deficit Disorder with Hyperactivity, Craniocerebral Trauma, Brain Concussion, Head Injuries, Closed, Brain Edema, Brain Hemorrhage, Traumatic, Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIMBehavioural
An online, 12 week research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury.
| Study group | Role | What they receive |
|---|---|---|
| AIM Intervention | Experimental | Not described Receives: Behavioral: AIM |
| Wait List Control | Experimental | Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention Receives: Behavioral: AIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Report Measures
Measured: 3 years
Secondary outcomes (1)
Teacher Report Measures
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Based on data from pilot study, the PI and program officer have determined that this study was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education, University of Oregon
- Responsible party
- Sponsor
- Investigators
- Shari L Wade, PhD, Principal investigator, Cincinnati Children's Hosiptal Medical CenterMcKay M Sohlberg, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779427
- Sponsor's protocol ID
- H133B090010--03
- Acronym
- AIM
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Attention Intervention Management
- ClinicalTrials.gov ID
- NCT01779427
- Acronym / sponsor ID
- AIM / H133B090010--03
- Conditions
- Traumatic Brain Injury (TBI), Attention Deficit Hyperactivity Disorder (ADHD), Head Injury, Brain Concussion, Head Injuries, Closed
- Keywords
- traumatic brain injury (TBI), intracranial edema, brain edema, craniocerebral trauma, head injury, brain hemorrhage, traumatic, subdural hematoma, brain concussion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Based on data from pilot study, the PI and program officer have determined that this study was not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- U.S. Department of Education, University of Oregon
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Jan 2013 (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.
This is a research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury.
Detailed description
Impairments in attention are among the symptoms most frequently reported by parents and teachers following pediatric traumatic brain injury (TBI_. These cognitive disabilities are responsible for a wide range of academic and adjustment issues. Broadly defined, attention encompasses all of the mental processes, operations, and systems requisite for acquiring and applying information. It interacts with other cognitive functions including perception, memory/learning, organization, and reasoning; attention is core to the integration of those systems. A number of different attentional subcomponents with interconnected neural systems have been identified and shown to be differentially disrupted following trauma and other brain disorders, including maintenance or sustained attention, attentional selectivity, attentional capacity, and ability to effectively shift attention. Given the prevalence of attention difficulties and secondary attention deficit hyperactivity disorder (ADHD) following TBI, it is imperative to identify treatments to effectively address attention impairments.
The study will develop and pilot the Attention Intervention and Management program (AIM). AIM focuses on direct attention training in conjunction with metacognitive strategy training. Strategies are designed to improve focus and self regulation, reduce distractions, and enhance problem solving in academic settings. Integration of attention training and metacognitive strategies will help to ensure that the student can apply the skills across settings and situations.
The Randomized Controlled Trial (RCT) in Phase 2 of this project will address two interrelated hypotheses:
Hypothesis 1: Children receiving the Attention Intervention and Management (AIM) program will evidence better performance on standardized tests of attention and executive functions (EF) than those in the wait list control (WLC) group.
Hypothesis 2: Children receiving AIM will have fewer attention and EF problems than those in the WLC on parent and teacher rating scales of attention and EF.
Participants will include children ages 10-18 with significant evidence of attentional impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIM Intervention | Experimental | Behavioral: AIM |
| Wait List Control | Experimental | Behavioral: AIMParticipants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- ages 10-18
- significant evidence of attentional impairments
- moderate to severe TBI
- time since injury at least 6 months
- completion of inpatient rehabilitation (if needed
Key exclusion criteria (5 listed)
- Child does not live with parents or guardian
- Child or parent has history of hospitalization for psychiatric problem
- TBI is a result of child abuse
- Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)
- Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability
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 |
|---|---|---|
| AIMAn online, 12 week research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury. | Behavioural | AIM Intervention, Wait List Control |
Primary outcome
Parent Report Measures
Time frame: 3 years
1 secondary outcome
Teacher Report Measures
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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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.
Shari L Wade, PhD principal investigator
Cincinnati Children's Hosiptal Medical Center
McKay M Sohlberg, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIM in people with Traumatic Brain Injury (TBI) and Attention Deficit Hyperactivity Disorder (ADHD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Mar 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Report Measures (time frame: 3 years). 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 8 Mar 2016.