Improving New Learning and Memory in School Aged Children

NCT04741360 | Completed

• 1 other identifier: R-987-17
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The currently proposed study addresses a critical need in the clinical care of school-aged children with TBI through the modification of an existing, proven efficacious treatment protocol for learning and memory deficits in persons with moderate to severe TBI, the modified Story Memory Technique (mSMT), as well as the conduct of a pilot double blind, placebo-controlled, RCT of this new pediatric adaptation of the mSMT. Over a decade of research and development conducted at our center has demonstrated the mSMT to be effective for improving new learning and memory in adults with TBI, across three realms of functioning: objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in adults with TBI. Clinical applications around the world have equally attested to its utility in the clinical care of adults with TBI. This highlights the tremendous potential of the mSMT to vastly improve the everyday lives and educational successes of children and adoles-cents living with TBI and the resultant learning and memory deficits. The currently proposed pilot work will begin to document that efficacy. The results of this study therefore have the potential to change clinical practice, inform policy, and improve the lives of children and adolescents living with TBI.

Conditions

Traumatic Brain Injury

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

• CVLT-C Learning Slope

  Memory

  6 months

Study Arms (2)

Modified Story Memory Technique

EXPERIMENTAL

Other: Modified Story Memory Technique

Control

OTHER

Other: Modified Story Memory Technique

Interventions

Modified Story Memory Technique OTHER

10-session computerized program to improve new learning and memory

Control; Modified Story Memory Technique

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be between the ages of 9 and 17.
• Have sustained a TBI at least 1 year ago, that has affected his or her memory.
• Be able to speak and read English fluently.

You may not qualify if:

• Diagnosis of MS, or neurological injury or disease in the past (like brain tumor or epilepsy).
• History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
• Uncontrolled seizures or other unstable medical complications.

Sponsors & Collaborators

• Kessler Foundation: lead
• New Jersey Commission on Brain Injury Research: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Study Start: October 25, 2017
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)