We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Prospective Memory in Children With Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00061399
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : October 29, 2014
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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).

Condition or disease
Traumatic Brain Injury

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
Estimated Enrollment : 178 participants
Time Perspective: Prospective
Official Title: Prospective Memory in Normal and Head-Injured Children
Study Start Date : July 2002
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061399

Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Stephen R. McCauley, Ph.D. Baylor College of Medicine

ClinicalTrials.gov Identifier: NCT00061399     History of Changes
Other Study ID Numbers: K23HD040896 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2003    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: April 2007

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Prospective memory

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries