Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

Alabama Parenting Questionnaire (APQ)

measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 ("never") to 5 ("always"). Items summed into composite scales. Within subject comparison of no medication baseline vs. optimal dose medication.

Time frame: baseline and week 4

Disruptive Behavior Disorders Rating Scale (DBD)

Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.

Time frame: baseline and week 4

Impairment Rating Scale (IRS)

Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by "no problems / no need for treatment" and at the high end by "extreme problem / definitely needs treatment." Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication.

Time frame: baseline and week 4

Sheehan Disability Scale (SDS)

The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.

Time frame: baseline and week 4

Dyadic Parent-Child Interaction Coding System (DPICS)

Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.

Time frame: weeks 4 and weeks 5 (period I within subjects trial)

Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages

Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.

Time frame: weeks 4 and weeks 5 (period I within subjects trial)

Pittsburgh Side Effect Rating Scale

rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.

Time frame: baseline and end of dose optimization phase/week 4

Adult ADHD Rating Scale (ADHD RS)

measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Parenting Stress Index (PSI)--Total Stress

measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Parenting Locus of Control (PLC)

self completed parenting measure of the degree to which parents feel they can influence their child's behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 ("strongly disagree") to 5 ("strongly agree"). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Brown Attention Deficit Scale (BAADS)

Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 ("never") to 3 ("almost daily"). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Social Skills Rating System (SSRS)

Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 ("never") to 2 ("often").At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior).

Time frame: study endpoint- end of period II (between subjects trial)

Disruptive Behavior Disorder Rating Scale (DBD)

measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).

Time frame: study endpoint- end of period II (between subjects trial)

Impairment Rating Scale (IRS)

measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Sheehan Disability Scale (SDS)

The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

ADHD Severity Clinical Global Impressions Severity Subscale

clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Barkley Home Situations Questionnaire (HSQ)

Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).

Time frame: study endpoint- end of period II (between subjects trial)

Pittsburgh Side Effect Rating Scale Mean Severity Rating.

rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Resting Blood Pressure

Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).

Time frame: study endpoint- end of period II (between subjects trial)

Alabama Parenting Questionnaire (APQ)

measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 ("never") to 5 ("always"). Items summed into composite scales. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

Time frame: study endpoint- end of period II (between subjects trial)

Impairment Rating Scale (IRS)

self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.

Time frame: study endpoint- end of period II (between subjects trial)

Weight

Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).

Time frame: study endpoint- end of period II (between subjects trial)

Resting Pulse

measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).

Time frame: study endpoint- end of period II (between subjects trial)

Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More

Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).

Time frame: end of medication optimization phase/week 4

Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase

Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.

Time frame: baseline and end of med optimization phase/week 4