Lab School Day Study for CONCERTA of Older Children With ADHD

PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)

Time frame: Hour 4 of the of the Lab School Day during Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point. Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/CONCERTA (lab day 1/lab day 2) plus the 35 children randomized to CONCERTA/Placebo

PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.

Time frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

This task, presented once during a laboratory school day, was designed to index attention to detail by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.

Time frame: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.

Time frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.

Time frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher's directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.

Time frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (\<= -1.80) are considered not within normal limits scores above -1.80 (\> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.

Time frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.

Time frame: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.

Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).

Time frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period

Population: Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.