Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
Study Details
Study Description
Brief Summary
It is now well recognized that Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder of childhood that extends into adulthood for many individuals. A number of impairments in daily life functioning have been identified in adults with ADHD, including marital distress, risky driving, and using less effective parenting practices (e.g., Barkley, 2006).
Specifically, some parents with ADHD have been found to use inconsistent discipline, less parental involvement, and less positive reinforcement with their children compared to parents without ADHD (e.g., Chen & Johnston, 2007; Chronis-Tuscano, Clarke, Rooney, Diaz, & Pian, 2008). While there is some evidence that stimulant medication improves parental functioning for adults with ADHD, only one study has specifically explored the use of stimulant medication and parenting(Chronis-Tuscano, Seymour, Stine, Jones, Jiles, Rooney, et al., 2008).
The purpose of this study is to explore whether or not the stimulant medication, lisdexamfetamine, improves parent functioning. Measures of parenting behavior, parental psychosocial functioning, and child psychosocial functioning will be collected. It is hypothesized that lisdexamfetamine will be associated with some improvement in these assessments.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
Seventy families with at least one parent (either mother or father who will serve as the identified subject) and a school-aged child (ages 5-16) with ADHD will be recruited to participate in a randomized, placebo-controlled trial of lisdexamfetamine to assess the acute and prolonged effects of medication usage on parent-child interactions. The protocol will employ traditional self-report measures of parental competency and functioning used in other studies, but will supplement them with one of the most widely used observational laboratory tasks.
Families will be recruited on a rolling basis and the length of the study will be approximately 8 weeks. In the first three weeks of the study, parents will complete the dose optimization phase to find the optimal dose of lisdexamfetamine. Lisdexamfetamine will be initiated at a dose of 30mg and increased to 50mg for week 2 and 70mg for week 3. During week 4, measures of the acute effects of lisdexamfetamine will be collected, and parents will complete the observational laboratory parent child interaction tasks two times (i.e., on lisdexamfetamine and on placebo- phase I). In the remaining four weeks of the study (phase 2) a between subjects comparison will be conducted. Half of the parents will be randomized to receive lisdexamfetamine and half will receive a placebo. Measures of parent functioning will once again be collected at the end of phase 2 and parents will complete the observational laboratory task, which will allow for exploration of prolonged lisdexamfetamine treatment on parent-child interactions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: stimulant medication blinded lisdexamfetamine at the optimal dose for the individual participant as previously determined during the med optimization portion of the study |
Drug: lisdexamfetamine
3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg
Other Names:
|
| Placebo Comparator: placebo pill placebo medication identical in appearance to active med |
Drug: lisdexamfetamine
3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts [study endpoint- end of period II (between subjects trial)]
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. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).
- Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages [study endpoint- end of period II (between subjects trial)]
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. 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.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).
Secondary Outcome Measures
- Alabama Parenting Questionnaire (APQ) [baseline and week 4]
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.
- Disruptive Behavior Disorders Rating Scale (DBD) [baseline and week 4]
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.
- Impairment Rating Scale (IRS) [baseline and week 4]
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.
- Sheehan Disability Scale (SDS) [baseline and week 4]
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.
- Dyadic Parent-Child Interaction Coding System (DPICS) [weeks 4 and weeks 5 (period I within subjects trial)]
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.
- Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages [weeks 4 and weeks 5 (period I within subjects trial)]
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.
- Pittsburgh Side Effect Rating Scale [baseline and end of dose optimization phase/week 4]
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.
- Adult ADHD Rating Scale (ADHD RS) [study endpoint- end of period II (between subjects trial)]
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).
- Parenting Stress Index (PSI)--Total Stress [study endpoint- end of period II (between subjects trial)]
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).
- Parenting Locus of Control (PLC) [study endpoint- end of period II (between subjects trial)]
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).
- Brown Attention Deficit Scale (BAADS) [study endpoint- end of period II (between subjects trial)]
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).
- Social Skills Rating System (SSRS) [study endpoint- end of period II (between subjects trial)]
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).
- Disruptive Behavior Disorder Rating Scale (DBD) [study endpoint- end of period II (between subjects trial)]
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).
- Impairment Rating Scale (IRS) [study endpoint- end of period II (between subjects trial)]
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).
- Sheehan Disability Scale (SDS) [study endpoint- end of period II (between subjects trial)]
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).
- ADHD Severity Clinical Global Impressions Severity Subscale [study endpoint- end of period II (between subjects trial)]
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).
- Barkley Home Situations Questionnaire (HSQ) [study endpoint- end of period II (between subjects trial)]
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).
- Pittsburgh Side Effect Rating Scale Mean Severity Rating. [study endpoint- end of period II (between subjects trial)]
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).
- Resting Blood Pressure [study endpoint- end of period II (between subjects trial)]
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).
- Alabama Parenting Questionnaire (APQ) [study endpoint- end of period II (between subjects trial)]
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).
- Impairment Rating Scale (IRS) [study endpoint- end of period II (between subjects trial)]
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.
- Weight [study endpoint- end of period II (between subjects trial)]
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).
- Resting Pulse [study endpoint- end of period II (between subjects trial)]
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).
- Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More [end of medication optimization phase/week 4]
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).
- Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase [baseline and end of med optimization phase/week 4]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Parents with a diagnosis of ADHD, who also have a child with an ADHD between the ages of 5-16
Exclusion Criteria:
-
Parents with any of the following: any identified structural heart abnormality or other health condition that significantly affects heart performance (e.g., hypertension), a resting systolic blood pressure ≥140 and diastolic blood pressure ≥90, pregnant or breast feeding, significant psychiatric problems other than ADHD that currently require medication or any emergent psychiatric treatment, medical/psychiatric illness that could be worsened by stimulants (such as a seizure disorder, Tourette's Disorder or hyperthyroidism), or alcohol or substance abuse problems in the past 6 months.
-
Children with any of the following: any psychiatric problem other than ADHD, Oppositional Defiant Disorder (ODD), or Conduct Disorder (CD) that requires medication or any emergent psychiatric treatment, either parent or child has participated in the same parent-child interaction task used in this study in the last 6 months, either as part of a study or a clinical treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida International University | Miami | Florida | United States | 33199 |
Sponsors and Collaborators
- Florida International University
Investigators
- Principal Investigator: James G Waxmonsky, M.D., Florida International University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IITWW#2
Study Results
Participant Flow
| Recruitment Details | Participants were recruited by direct advertisement as well as from referrals from mental health and medical providers. |
|---|---|
| Pre-assignment Detail | Participants first stabilized on LDX in 3 week open label trial starting at 30mg + increasing by 20mg/week until optimal dose was found. Those unable to tolerate LDX or not responsive to it were discontinued. 38 enrolled; 8 dropped out due to adverse events + 3 were lost to follow up in med phase, leaving 27. |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II. | All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II. |
| Period Title: Phase I (Within Subjects) | ||
| STARTED | 14 | 13 |
| COMPLETED | 14 | 13 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Phase I (Within Subjects) | ||
| STARTED | 14 | 13 |
| COMPLETED | 13 | 11 |
| NOT COMPLETED | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Placebo Arm | Treatment Arm | Total |
|---|---|---|---|
| Arm/Group Description | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial. | Total of all reporting groups |
| Overall Participants | 14 | 13 | 27 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
14
100%
|
13
100%
|
27
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
41.38
(4.41)
|
40.69
(6.06)
|
41.04
(5.20)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
11
78.6%
|
9
69.2%
|
20
74.1%
|
| Male |
3
21.4%
|
4
30.8%
|
7
25.9%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
14
100%
|
13
100%
|
27
100%
|
Outcome Measures
| Title | Alabama Parenting Questionnaire (APQ) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Used a within-subjects evaluation; the same 24 participants evaluated in both arms. |
| Arm/Group Title | Unmedicated | Optimal Dose of Medication |
|---|---|---|
| Arm/Group Description | Data collected at intake, when participants were not on medication | Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg) |
| Measure Participants | 24 | 24 |
| Parent Involvement |
37.83
(5.64)
|
38.82
(5.30)
|
| Positive parenting |
25.42
(3.60)
|
25.58
(2.86)
|
| Poor monitoring and poor supervision |
14.25
(3.84)
|
13.58
(3.20)
|
| Inconsistent discipline |
15.79
(3.51)
|
14.62
(3.87)
|
| Corporal punishment |
4.79
(2.04)
|
4.42
(1.72)
|
| Title | Disruptive Behavior Disorders Rating Scale (DBD) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Used a within-subjects design; the same 24 participants measured in both arms. |
| Arm/Group Title | Unmedicated | Optimal Dose of Medication |
|---|---|---|
| Arm/Group Description | Data collected at intake, when participants were not on medication | Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg) |
| Measure Participants | 24 | 24 |
| ADHD-hyperactive/impulsive symptom score |
1.55
(0.76)
|
1.34
(0.61)
|
| ADHD-inattentive symptom score |
2.11
(0.59)
|
1.85
(0.74)
|
| ODD symptom score |
1.17
(0.69)
|
1.12
(0.69)
|
| CD symptom score |
0.16
(0.14)
|
0.18
(0.24)
|
| Title | Impairment Rating Scale (IRS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Uses a within-subjects evaluation; the same 25 participants are in both arms. |
| Arm/Group Title | Unmedicated | Optimal Dose of Medication |
|---|---|---|
| Arm/Group Description | Data collected at intake, when participants were not on medication | Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg) |
| Measure Participants | 24 | 24 |
| Child's peer relationship impairment |
2.75
(2.15)
|
2.21
(1.69)
|
| Child's sibling relationship impairment |
2.82
(2.34)
|
2.68
(1.99)
|
| Child's parent relationship impairment |
3.67
(1.88)
|
3.79
(1.56)
|
| Child's academic impairment |
3.75
(2.13)
|
3.29
(2.03)
|
| Child's self-esteem impairment |
3.92
(1.95)
|
3.54
(1.72)
|
| Child's family impairment |
4.00
(1.83)
|
3.87
(1.49)
|
| Child's overall impairment |
3.63
(1.86)
|
3.42
(1.59)
|
| Title | Sheehan Disability Scale (SDS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Uses a within-subjects design; the same 25 participants are in both arms. |
| Arm/Group Title | Unmedicated | Optimal Dose of Medication |
|---|---|---|
| Arm/Group Description | Data collected at intake, when participants were not on medication | Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg) |
| Measure Participants | 25 | 25 |
| Mean (Standard Deviation) [units on a 0 to 10 scale] |
6.26
(2.11)
|
3.17
(2.65)
|
| Title | Dyadic Parent-Child Interaction Coding System (DPICS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Used a within-subjects design for this phase; the same 26 participants completed all four arms. |
| Arm/Group Title | Placebo - Homework Task | Placebo - Non-academic Task | Medication - Homework Task | Medication Non-academic Task |
|---|---|---|---|---|
| Arm/Group Description | Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) |
| Measure Participants | 26 | 26 | 26 | 26 |
| Verbalizations |
61.7
(30.9)
|
58.2
(31.1)
|
45.2
(21.1)
|
48.6
(26.5)
|
| Commands |
15.4
(11.5)
|
14.8
(10.3)
|
8.7
(5.2)
|
8.3
(4.1)
|
| inappropriate child behavior |
6.1
(10.0)
|
3.3
(4.9)
|
2.5
(2.1)
|
3.8
(5.4)
|
| Title | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Used a within-subjects design; the same 26 participants completed all arms. |
| Arm/Group Title | Placebo - Homework Task | Placebo - Non-academic Task | Medication - Homework Task | Medication Non-academic Task |
|---|---|---|---|---|
| Arm/Group Description | Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) |
| Measure Participants | 26 | 26 | 26 | 26 |
| Parent praise |
2.6
(3.7)
|
3.0
(4.5)
|
3.6
(5.8)
|
2.2
(2.5)
|
| Parent negative talk |
4.7
(5.7)
|
4.0
(3.6)
|
14.4
(11.7)
|
9.1
(8.7)
|
| Parent demandingness |
24.1
(10.7)
|
25.7
(11.3)
|
19.3
(6.4)
|
19.2
(10.5)
|
| Parent impatient |
39.2
(12.8)
|
42.5
(18.7)
|
31.2
(15.7)
|
32.6
(10.4)
|
| Parent responsive |
83.2
(25.9)
|
74.8
(30.4)
|
75.9
(15.3)
|
79.8
(12.8)
|
| Title | Pittsburgh Side Effect Rating Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms. |
| Arm/Group Title | Unmedicated | Optimal Dose of Medication |
|---|---|---|
| Arm/Group Description | baseline; participants not on medication | Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial. |
| Measure Participants | 26 | 26 |
| Mean (Standard Deviation) [units on a scale] |
0.04
(0.12)
|
0.26
(0.21)
|
| Title | Adult ADHD Rating Scale (ADHD RS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 11 |
| Inattention |
17.85
(8.21)
|
8.82
(6.54)
|
| Hyperactive/Impulsive |
14.77
(8.23)
|
5.64
(5.07)
|
| Total Score |
32.62
(15.61)
|
14.46
(10.91)
|
| Title | Parenting Stress Index (PSI)--Total Stress |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 9 |
| Mean (Standard Deviation) [units on a scale] |
241.54
(47.33)
|
262.67
(38.84)
|
| Title | Parenting Locus of Control (PLC) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 9 |
| Mean (Standard Deviation) [units on a scale] |
79.00
(4.22)
|
80.00
(5.57)
|
| Title | Brown Attention Deficit Scale (BAADS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial. |
| Measure Participants | 13 | 10 |
| Activation Scale t-score |
73.38
(11.52)
|
66.4
(13.5)
|
| Attention Scale t-score |
75.54
(11.90)
|
65.10
(11.19)
|
| Effort scale t-score |
72.46
(15.56)
|
61.20
(10.98)
|
| Affect scale t-score |
63.46
(15.37)
|
53.20
(5.57)
|
| Memory scale t-score |
74.38
(63.90)
|
13.79
(13.58)
|
| Total scale t-score |
76.08
(14.79)
|
63.30
(70.52)
|
| Title | Social Skills Rating System (SSRS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial. |
| Measure Participants | 11 | 10 |
| Social Skills Total Standard Score |
86.64
(17.72)
|
89.90
(13.68)
|
| Problem Behavior Total Standard Score |
113.81
(12.54)
|
111.80
(16.55)
|
| Title | Disruptive Behavior Disorder Rating Scale (DBD) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 12 | 10 |
| Inattention |
1.64
(0.76)
|
1.60
(0.39)
|
| Hyperactive/Impulsive |
1.25
(0.66)
|
1.09
(0.62)
|
| Oppositional-defiant |
1.04
(0.56)
|
0.76
(0.54)
|
| Conduct disorder |
0.17
(0.23)
|
0.15
(0.16)
|
| Title | Impairment Rating Scale (IRS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 10 |
| Impairment with peers |
2.62
(2.02)
|
2.20
(2.04)
|
| Impairment with siblings |
2.17
(2.21)
|
2.30
(1.89)
|
| Impairment interferes with parents' relationship |
3.15
(1.57)
|
3.10
(1.85)
|
| Academic impairment |
3.15
(2.23)
|
2.60
(2.07)
|
| Self-esteem impairment |
3.00
(2.04)
|
3.40
(1.96)
|
| General family impairment |
3.08
(1.85)
|
2.90
(1.85)
|
| Overall severity |
2.62
(1.66)
|
2.70
(1.64)
|
| Title | Sheehan Disability Scale (SDS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 9 |
| Mean (Standard Deviation) [units on a scale] |
4.36
(2.60)
|
2.26
(1.90)
|
| Title | ADHD Severity Clinical Global Impressions Severity Subscale |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 11 |
| Mean (Standard Deviation) [units on a scale] |
3.78
(1.24)
|
2.36
(0.81)
|
| Title | Barkley Home Situations Questionnaire (HSQ) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial | Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial. |
| Measure Participants | 10 | 9 |
| Mean (Standard Deviation) [number of child problems endorsed] |
9.30
(4.67)
|
8.67
(5.22)
|
| Title | Pittsburgh Side Effect Rating Scale Mean Severity Rating. |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 10 |
| Mean (Standard Deviation) [units on a scale] |
0.28
(0.10)
|
0.26
(0.12)
|
| Title | Resting Blood Pressure |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 10 | 9 |
| systolic BP |
123.40
(8.90)
|
122.33
(11.45)
|
| diastolic BP |
76.10
(8.74)
|
75.11
(7.98)
|
| Title | Alabama Parenting Questionnaire (APQ) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 9 |
| Positive parenting |
24.85
(3.46)
|
24.33
(3.77)
|
| Parental involvement |
39.38
(5.38)
|
37.78
(4.55)
|
| Poor monitoring/supervision |
12.23
(3.14)
|
12.33
(2.40)
|
| Inconsistent discipline |
12.46
(3.84)
|
14.22
(2.86)
|
| Corporal punishment use |
4.69
(1.80)
|
3.89
(1.17)
|
| Title | Impairment Rating Scale (IRS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 13 | 11 |
| Impairment with peers |
2.38
(1.50)
|
1.91
(1.70)
|
| Impairment with parents |
2.46
(2.03)
|
1.30
(1.64)
|
| General family impairment |
2.77
(1.88)
|
2.27
(1.79)
|
| Academic impairment |
3.60
(2.88)
|
1.83
(2.04)
|
| Self-esteem impairment |
2.77
(2.09)
|
2.00
(1.84)
|
| Overall impairment |
3.00
(1.73)
|
2.55
(1.75)
|
| Title | Weight |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 11 | 9 |
| Mean (Standard Deviation) [kg] |
76.0
(24.78)
|
69.62
(17.71)
|
| Title | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts |
|---|---|
| Description | 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. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects. |
| Arm/Group Title | Placebo - Homework Task | Placebo - Non-academic Task | Medication - Homework Task | Medication Non-academic Task |
|---|---|---|---|---|
| Arm/Group Description | Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) |
| Measure Participants | 13 | 13 | 10 | 10 |
| Verbalizations |
67.2
(35.4)
|
42.1
(16.2)
|
53.8
(31.6)
|
40.1
(24.0)
|
| Commands |
14.5
(8.8)
|
9.0
(4.2)
|
11.0
(6.6)
|
4.9
(3.3)
|
| inappropriate child behavior |
6.8
(6.2)
|
1.4
(2.5)
|
3.8
(4.7)
|
1.5
(1.9)
|
| Title | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages |
|---|---|
| Description | 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. 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.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects. |
| Arm/Group Title | Placebo - Homework Task | Placebo - Non-academic Task | Medication - Homework Task | Medication Non-academic Task |
|---|---|---|---|---|
| Arm/Group Description | Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) | Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo) |
| Measure Participants | 13 | 13 | 10 | 10 |
| Parent praise |
1.2
(2.2)
|
6.0
(6.0)
|
2.8
(2.5)
|
5.7
(6.2)
|
| Parent negative talk |
5.3
(4.3)
|
5.9
(8.6)
|
21.1
(21.0)
|
12.6
(10.2)
|
| Parent demandingness |
21.8
(8.9)
|
23.5
(10.9)
|
21.7
(10.1)
|
12.7
(6.5)
|
| Parent impatient |
42.4
(11.3)
|
38.7
(20.7)
|
34.1
(12.9)
|
26.3
(11.0)
|
| Parent responsive |
69.8
(33.3)
|
89.7
(18.1)
|
63.8
(35.8)
|
77.3
(18.8)
|
| Title | Resting Pulse |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Placebo Arm | Treatment Arm |
|---|---|---|
| Arm/Group Description | participants in this arm treated with matching placebo for 4 weeks duration | participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg) |
| Measure Participants | 9 | 8 |
| Mean (Standard Deviation) [bpm] |
74.44
(7.58)
|
77.13
(4.19)
|
| Title | Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Within-subjects analysis; data entered per dose not per subject. For example, if subject 1 took 30mg, 50mg and 70mgdoses during titration, they are recorded as three separate entries. Sample size reduces as dose increases because participants stopped at lowest acceptable dose and only moved to higher dose if they did not meet optimization criteria. |
| Arm/Group Title | No Medication | 30 mg Lisdexamfetamine | 50 mg Lisdexamfetamine | 70 mg Lisdexamfetamine |
|---|---|---|---|---|
| Arm/Group Description | The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD. | This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it. | This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study. | This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose. |
| Measure Participants | 38 | 36 | 21 | 17 |
| Motor tics |
0
0%
|
0
0%
|
0
0%
|
11.8
NaN
|
| Buccal-lingual movement |
2.6
18.6%
|
19.4
149.2%
|
28.6
105.9%
|
23.5
NaN
|
| picking at skin |
13.2
94.3%
|
11.1
85.4%
|
14.3
53%
|
5.9
NaN
|
| worried/anxious |
13.2
94.3%
|
36.1
277.7%
|
14.3
53%
|
17.6
NaN
|
| dull, tired, listless |
10.5
75%
|
16.7
128.5%
|
9.5
35.2%
|
11.8
NaN
|
| headaches |
5.3
37.9%
|
36.1
277.7%
|
28.6
105.9%
|
29.4
NaN
|
| stomachaches |
0.0
0%
|
16.7
128.5%
|
4.8
17.8%
|
29.4
NaN
|
| crabby, irritiable |
10.5
75%
|
27.8
213.8%
|
23.8
88.1%
|
23.5
NaN
|
| tearful, sad, depressed |
7.9
56.4%
|
13.9
106.9%
|
19.0
70.4%
|
11.8
NaN
|
| socially withdrawn |
5.3
37.9%
|
8.3
63.8%
|
0.0
0%
|
0.0
NaN
|
| loss of appetite |
0.0
0%
|
52.8
406.2%
|
66.7
247%
|
70.6
NaN
|
| trouble sleeping |
10.5
75%
|
30.6
235.4%
|
33.3
123.3%
|
35.3
NaN
|
| dry mouth |
0.0
0%
|
30.6
235.4%
|
38.1
141.1%
|
70.5
NaN
|
| Title | Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Uses a within-subjects design; the same 27 participants are in both arms. |
| Arm/Group Title | Unmedicated | Optimal Dose of Medication |
|---|---|---|
| Arm/Group Description | Data collected at intake, when participants were not on medication | Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg) |
| Measure Participants | 27 | 27 |
| Inattention Symptoms |
23.12
(3.58)
|
9.77
(4.44)
|
| Hyperactive/Impulsive Symptoms |
17.81
(5.73)
|
8.00
(5.08)
|
| Total symptoms |
40.85
(7.55)
|
17.77
(8.51)
|
Adverse Events
| Time Frame | Adverse event data reported for period II (mean duration 8 weeks). While 27 total subjects were randomized to a treatment arm (med vs.placebo), 1 withdrew before med was dispensed which is why we have side effect data for 26 and not 27. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Pittsburgh Side Effect Scale (PSERS) was given at every visit to all participants to measure adverse events. It contains 13 items measured medication side effects from 0 (none) to 3 (severe). The Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicide risk. It was given at every visit. Both measures were self completed. | |||||||||
| Arm/Group Title | Placebo Arm | Treatment Arm | All Participants in Period 1 Prescribed 30mg | All Participants in Period 1 Prescribed 50mg | All Participants in Period 1 Prescribed 70mg | |||||
| Arm/Group Description | subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects. | subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial). | During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant. All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category. | During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant. 21 of 36 participants were dispensed the 50mg dose. | During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant. 17 of 36 participants were dispensed the 70mg dose. | |||||
All Cause Mortality |
||||||||||
| Placebo Arm | Treatment Arm | All Participants in Period 1 Prescribed 30mg | All Participants in Period 1 Prescribed 50mg | All Participants in Period 1 Prescribed 70mg | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Placebo Arm | Treatment Arm | All Participants in Period 1 Prescribed 30mg | All Participants in Period 1 Prescribed 50mg | All Participants in Period 1 Prescribed 70mg | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | 0/13 (0%) | 0/36 (0%) | 0/21 (0%) | 0/17 (0%) | |||||
| Psychiatric disorders | ||||||||||
| suicidal ideation | 0/13 (0%) | 0 | 0/11 (0%) | 0 | 0/36 (0%) | 0 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| self harm attempt | 0/13 (0%) | 0 | 0/11 (0%) | 0 | 0/36 (0%) | 0 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| Placebo Arm | Treatment Arm | All Participants in Period 1 Prescribed 30mg | All Participants in Period 1 Prescribed 50mg | All Participants in Period 1 Prescribed 70mg | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/13 (38.5%) | 5/13 (38.5%) | 34/36 (94.4%) | 18/21 (85.7%) | 15/17 (88.2%) | |||||
| Endocrine disorders | ||||||||||
| dry mouth | 1/13 (7.7%) | 1 | 3/13 (23.1%) | 3 | 11/36 (30.6%) | 11 | 8/21 (38.1%) | 8 | 12/17 (70.6%) | 12 |
| Gastrointestinal disorders | ||||||||||
| stomachache | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 6/36 (16.7%) | 6 | 1/21 (4.8%) | 1 | 5/17 (29.4%) | 5 |
| General disorders | ||||||||||
| fatigue | 2/13 (15.4%) | 2 | 1/13 (7.7%) | 1 | 6/36 (16.7%) | 6 | 2/21 (9.5%) | 2 | 2/17 (11.8%) | 2 |
| appetite decrease | 2/13 (15.4%) | 2 | 3/13 (23.1%) | 3 | 19/36 (52.8%) | 19 | 14/21 (66.7%) | 14 | 12/17 (70.6%) | 12 |
| insomnia | 4/13 (30.8%) | 4 | 3/13 (23.1%) | 3 | 11/36 (30.6%) | 11 | 7/21 (33.3%) | 7 | 6/17 (35.3%) | 6 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| knee pain | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 0/36 (0%) | 0 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Buccal Lingual Movements | 2/13 (15.4%) | 2 | 0/13 (0%) | 0 | 7/36 (19.4%) | 7 | 6/21 (28.6%) | 6 | 4/17 (23.5%) | 4 |
| picking at skin | 2/13 (15.4%) | 2 | 0/13 (0%) | 0 | 4/36 (11.1%) | 4 | 3/21 (14.3%) | 3 | 1/17 (5.9%) | 1 |
| headache | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 13/36 (36.1%) | 13 | 6/21 (28.6%) | 6 | 5/17 (29.4%) | 5 |
| motor tic | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 0/36 (0%) | 0 | 0/21 (0%) | 0 | 2/17 (11.8%) | 2 |
| Psychiatric disorders | ||||||||||
| anxious/jittery | 3/13 (23.1%) | 3 | 3/13 (23.1%) | 3 | 13/36 (36.1%) | 13 | 3/21 (14.3%) | 3 | 3/17 (17.6%) | 3 |
| irritability | 1/13 (7.7%) | 1 | 3/13 (23.1%) | 3 | 10/36 (27.8%) | 10 | 5/21 (23.8%) | 5 | 4/17 (23.5%) | 4 |
| depressed mood | 0/13 (0%) | 0 | 1/13 (7.7%) | 1 | 5/36 (13.9%) | 5 | 4/21 (19%) | 4 | 2/17 (11.8%) | 2 |
| socially withdrawn | 0/13 (0%) | 0 | 0/13 (0%) | 0 | 3/36 (8.3%) | 3 | 0/21 (0%) | 0 | 0/17 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. James Waxmonsky |
|---|---|
| Organization | Florida International University |
| Phone | 717 531 8646 |
| jwaxmons@fiu.edu |
- IITWW#2