Attention Intervention Management (AIM)

March 7, 2016 updated by: Children's Hospital Medical Center, Cincinnati

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AIM Intervention
Behavioral: AIM
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.
Experimental: Wait List Control
Participants are in the Wait List Control group for 10 weeks and then they will participate in the AIM Intervention
Behavioral: AIM
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parent Report Measures
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Teacher Report Measures
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

University of Oregon
U.S. Department of Education

Investigators

  • Principal Investigator: Shari L Wade, PhD, Cincinnati Children's Hosiptal Medical Center
  • Principal Investigator: McKay M Sohlberg, PhD, University of Oregon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H133B090010--03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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