NCT01779427

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

December 10, 2012

Last Update Submit

March 7, 2016

Conditions

Keywords

traumatic brain injury (TBI)intracranial edemabrain edemacraniocerebral traumahead injurybrain hemorrhage, traumaticsubdural hematomabrain concussionhead injuries, closedepidural hematomaextra-axial hemorrhagecortical contusionwounds and injuriesdisorders of environmental origintrauma, nervous systembrain injuriesattention deficit hyperactivity disorder (ADHD)attention

Outcome Measures

Primary Outcomes (1)

  • Parent Report Measures

    3 years

Secondary Outcomes (1)

  • Teacher Report Measures

    3 years

Study Arms (2)

AIM Intervention

EXPERIMENTAL
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

Behavioral: AIM

Interventions

AIMBEHAVIORAL

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.

AIM InterventionWait List Control

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticAttention Deficit Disorder with HyperactivityCraniocerebral TraumaBrain ConcussionHead Injuries, ClosedBrain EdemaBrain Hemorrhage, TraumaticHematoma, SubduralHematoma, Epidural, SpinalBrain ContusionWounds and InjuriesDisorders of Environmental OriginTrauma, Nervous SystemBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersWounds, NonpenetratingIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsContusions

Study Officials

  • Shari L Wade, PhD

    Cincinnati Children's Hosiptal Medical Center

    PRINCIPAL INVESTIGATOR
  • McKay M Sohlberg, PhD

    University of Oregon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

January 30, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations