Methylphenidate for Attention Problems After Pediatric TBI

Phase 4CompletedNCT01933217

Children's Hospital Medical Center, Cincinnati26 enrolled

Overview

Traumatic Brain Injury (TBI) - methylphenidate treatment

The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems \>6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Traumatic Brain Injury TBI ADHD

Interventions

MethylphenidateDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Between ages of 6-17 * Sustained Moderate to Severe TBI * TBI occurred at least 6 months prior to beginning the study * TBI occurred no earlier than 5 years of age * Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale Exclusion Criteria: * History of developmental disability or mental retardation * Current active participation in ADHD-related behavioral intervention * History of psychiatric condition requiring an inpatient admission in past 12 months * Actively taking medications with a contraindication to Concerta that cannot be discontinued * Current use of stimulant medication or ADHD specific medications that cannot be discontinued * Non-blunt head injury * Family history of arrhythmia * Pregnancy

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)

Changes in symptom ratings were assessed on the Vanderbilt ADHD parent rating scales (VADPRS). A measure of ADHD symptom severity (Total Symptom Score \[TSS\]) is computed by totaling the scores from items 1-18 (Inattentive +Hyperactive-impulse domains), with a rating of none=0, occasionally=1, often=2, very often=3, provided. Scores for inattentive and hyperactive-impulsive domains were generated by totaling the 9 symptoms in these domains, and a TSS was computed by totaling items across domains.

Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)

Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)

The Behavior Rating Inventory of Executive Functioning (BRIEF)-Parent was used to assess executive functioning behaviors. The global executive composite (GEC), behavior regulatory index (BRI), and metacognitive index (MI) T-scores were used, with higher scores reflecting poorer executive functioning. T-scores were normalized to 50 with a standard deviation of 10.

Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)

Secondary Outcomes

Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)

The Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) has been designed for children 6-16:11 years of age and provides a measure of processing speed. For this index scale, the average score is 100 with a standard deviation of 15. Higher scores reflect better processing speed. One participant was administered the Wechsler Adult Intelligence Scale 4th Edition Processing Speed Index (WAIS-IV-PSI). All scores were included in the combined WISC/WAIS processing speed variable since both measures yield highly correlated standard scores.

Time frame: Reported at End of Methylphenidate Arm (Week 4 or 8)

Teacher Outcome Measure

Used to assess child behavior.

Data from ClinicalTrials.gov

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