Prospective Memory in Children With Traumatic Brain Injury

October 28, 2014 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Prospective Memory in Normal and Head-Injured Children

Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note to someone when you next see them, pick up milk on the way home, or remembering to keep an appointment. This study will evaluate PM in children with traumatic brain injury (TBI).

Study Overview

Status

Completed

Conditions

Detailed Description

While much has been learned about how children with TBIs learn and recall stories, word lists, and pictures, little is known about how they perform PM tasks. Impairment in PM could have serious implications for academic and vocational pursuits. This study will investigate PM in children with mild or severe TBI. The study will focus on three major themes: 1) strategies that may help children with TBI overcome or minimize their PM deficits; 2) how specific areas of cognition can be impaired following TBI and in turn impair PM; and 3) the impact of PM deficits on a child's daily functioning, both at school and at home. The study will also evaluate children without TBI (control group).

Each child will participate in one study evaluation. The evaluation will last approximately 4 hours, with a lunch break and other rest breaks as necessary. Assessments will include neuropsychological tests of attention, memory, and general intellectual functioning. Experimental tasks will include measures of metacognition for prospective memory, elucidation of strategic versus automatic processes involved in PM, and the effect of motivation manipulations in overcoming PM deficits with varying working memory loads. The child's parent or guardian will also be asked to complete some tests to measure the impact of PM deficits on the child's daily home life.

Study Type

Observational

Enrollment

178

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

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • English speaker
  • Minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation

Additional Inclusion Criteria for Children with Traumatic Brain Injury

  • Head injury resulting in a post-resuscitation Glasgow Coma Scale score of either 13 to 15 or 3 to 8
  • No evidence of hypoxic injury

Exclusion Criteria

  • History of epilepsy, mental retardation, or documented evidence of developmental dysfunction
  • Previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms
  • History of autism, major psychiatric disorder, or pervasive developmental delay
  • History of meningitis or encephalitis
  • History of child abuse
  • History of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.)
  • Note: siblings of participants with TBI or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups

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

Collaborators and Investigators

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

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Stephen R. McCauley, Ph.D., Baylor College of Medicine

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

July 1, 2002

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 27, 2003

First Submitted That Met QC Criteria

May 27, 2003

First Posted (Estimate)

May 28, 2003

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23HD040896 (U.S. NIH Grant/Contract)

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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