Design and Methodology

The testing is based on a double blind single subject design. Within this construct, the subject serves as their own control. Hence, performance is measured based on a pre/post testing model. Simply put, performance is measured based on how one performs on and off medication.

Variables (what is measured)

Testing is based on verbal, visual, paper-pencil and computer testing. The tests have been developed based on various mainstream tests (e.g., psychological tests). The following variables will be measured during Phase I:

1. Short Term Memory (e.g., Digit Span)
2. Long Term Memory (e.g., Digit Span)
3. Kinesthetic Memory (e.g., SIPT)
4. Memory Consolidation (e.g., Kinesthetic memory, Reaction Time, Picture Memory)
5. Reaction Time (TOVA)
6. Distractibility (TOVA)
7. Attention (TOVA)
8. Executive Concentration (e.g., Digit Span, STROOP)
9. ADHD behaviors (online questionnaire and Conner's Rating Scale)
10. EEG and Autonomic Responses (Phase II)
11. Fidgetiness (Phase II)

Please contact us for a detailed description of tests used.

 

Protocol

 

Who qualifies

The following conditions must be met before participating in the ADHD assessment:

1. Intelligence within normal range
2. Ability to comprehend and express self
3. Consent/supervision from treating physician
4. Diagnosis of ADHD and current prescription for ADHD medication
5. Supervision by physician (for medication)
6. Ability to follow 1-2 step directions

The following conditions will exclude the child from testing:

1. History of Tic Disorder
2. Does not meet the above criteria

1. Familiarization package (Practice Effect)

Before commencing the study, you will receive a "familiarization package" that includes a DVD and sample materials. The aim of this package is to familiarize the subject with the test materials and to reduce the practice effect.

2. Testing

(Double Blind)

The term Double Blind means that neither the subject, nor the tester know when medication or Placebo (sugar pill) is be administered; this information is obtained at the end of the study. This ensures that the subject or the tester put forth their best effort without being affected by how they think they should act on and off the medication.

In addition, testing is conducted in the same order on both days, at the same time. This is done to control for factors such as time of day effect and to keep consistency in as many variables as possible.

(Placebo vs. Medication)

Once the physician prescribes the medication, our Pharmacist will provide the subject with 14 envelopes (6 envelopes marked A1, A2....A6 for home), (2 envelopes marked B and C for testing at the clinic) and (6 envelopes marked D1, D2...D7). If envelopes A contain the Placebo, then envelopes D will contain the medication. The other possibility is that envelopes D contain the Placebo, and envelopes A contain the medication. Envelope E will contain the description of which set of pills was the medication and which was the Placebo. This information will not be discovered until the final day of testing (day 14).

Please note that testing will begin approximately one hour after the pill (medication or Placebo) is ingested to allow for the medication to reach it's full effect.

In total, there are 4 variations of when the subject receives the medications and Placebo (see table 1). A detailed description of Variation 1 can be seen in table 2.

Variation 1				Variation 2
Week 1	Drug	No Drug		Week 1	Drug	No Drug
Home	X			Home		X
Clinic	X			Clinic		X
Week 2				Week 2
Home		X		Home	X
Clinic		X		Clinic	X
Variation 3				Variation 4
Week 1	Drug	No Drug		Week 1	Drug	No Drug
Home	X			Home		X
Clinic		X		Clinic	X
Week 2				Week 2
Home		X		Home	X
Clinic	X			Clinic		X

table 1

(Detailed Protocol)

In variation 1 the subject receives the familiarization package before commencing taking the enclosed medication/placebo pills. Once familiarized with the testing, the subject begins to take pills A (in this case Placebo) for 6 days. At the end of each day, the parents or subject (if adult) fill out a confidential on-line questionnaire (subjective observations of behaviors and side-effects). On day 6, in addition to filling out an online questionnaire, parents or the subject (if adult) fill out a Conner's Questionnaire regarding the past 6 days of behavior.

Day 7 the subject is assessed at the clinic (in this case, receiving the Placebo). That evening the on-line questionnaire is filled out. Day 8 the subject again visits the clinic and repeats the testing conducted on day 7. On day 8, the subject receives the medication; begins to take pills B.

Once pre and post (in clinic) testing has been complete, the subject will continue to take take pills B (in this case medication) and complete the online questionnaire. On day 14, in addition to taking pills B and filling out an on-line questionnaire, parents or the subject (if adult) will complete a post trial Conner's questionnaire.

Variation 1 Day Drug Placebo Familiarization package     1 Home   X 2 Home   X 3 Home   X 4 Home   X 5 Home   X 6 Home & Conner's Q   X 7 Assessment   X 8 Assessment X   9 Home X   10 Home X   11 Home X   12 Home X   13 Home X   14 Home & Conner's Q X   15 Feedback

table 2

(Statistics)

Collected data will contain

• Subjective data: self report and behavior ratings.
• Objective data: standard scores (comparing the subject's performance to their peers), computer tests, paper pencil tests.
• Physiological (blood pressure, heart rate, EEG, EMG, EDR, respiration)
• Phase II may include Z-scores to compare different subtests on a consistent range of scores.