Autism, Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Autism, Autism Spectrum Disorders, ADHD
Brief summary
This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed. The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.
Detailed description
The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.
Interventions
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
Sponsors
Mark L. Wolraich, M.D.
University of Oklahoma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Between 6 and 11 years * Autism Spectrum Disorder * Attention Deficit Hyperactivity Disorder * Stimulant medication-free at study entry * No clinically significant abnormalities that preclude safe participation * Sufficient developmental level (\ 3 yrs) * Able to keep appointments * Able to communicate effectively * Teacher cooperation
Exclusion criteria
* Received an investigational medication in the previous 30 days * Current medication treatment is effective and well-tolerated * Medical conditions that affect patient safety * MAOIs within one month * Hypertension * Bipolar disorder or psychosis * Anticonvulsants * Psychotropic medication or health food supplement * Tourette Disorder * Seizure disorder * Neurological condition * Structural heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems). |
| Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems). |
| Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems). |
| Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems). |
| Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems). |
| Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported. |
| Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area. |
| Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area. |
| Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below. |
| Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit | Baseline, 8 weeks | The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning. |
Countries
United States
Participant flow
Recruitment details
16 enrolled Study Start Date: September, 2007 Study Completion Date:May, 2009 Seen at OU Physician's Child Study Center.
Participants by arm
| Arm | Count |
|---|---|
| Methylphenidate Transdermal System 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Follow-up | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Methylphenidate Transdermal System |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 7.83 years STANDARD_DEVIATION 1.23 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit | Baseline: ADHD-RS-IV Total Score | 39.9 units on a scale | Standard Deviation 7.7 |
| Methylphenidate Transdermal System | Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit | Follow-Up: ADHD-RS-IV Total Score | 13.8 units on a scale | Standard Deviation 9 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: <0.00195% CI: [19.6, 33.1]Mixed Models Analysis
Secondary
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit | Baseline: ABC HYPERACTIVITY | 34.1 units on a scale | Standard Deviation 8.3 |
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit | Follow-up: ABC HYPERACTIVITY | 11.3 units on a scale | Standard Deviation 8.4 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: <0.00195% CI: [16.9, 29.3]Mixed Models Analysis
Secondary
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit | Baseline: ABC Inappropriate Speech | 5.5 units on a scale | Standard Deviation 2.9 |
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit | Follow-up: ABC Inappropriate Speech | 2.1 units on a scale | Standard Deviation 2.3 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: <0.00195% CI: [1.8, 5.2]Mixed Models Analysis
Secondary
Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit | Baseline: ABC Irritability | 19.8 units on a scale | Standard Deviation 9.6 |
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit | Follow-up: ABC Irritability | 9.1 units on a scale | Standard Deviation 6.5 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: <0.00195% CI: [5.4, 16.8]Mixed Models Analysis
Secondary
Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit | Baseline: ABC Lethargy | 11.3 units on a scale | Standard Deviation 4.9 |
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit | Follow-up: ABC Lethargy | 4.5 units on a scale | Standard Deviation 3.6 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: <0.00195% CI: [3.3, 11.1]Mixed Models Analysis
Secondary
Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit | Baseline: ABC Stereotypy | 5.6 units on a scale | Standard Deviation 5.4 |
| Methylphenidate Transdermal System | Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit | Follow-up: ABC Stereotypy | 1.3 units on a scale | Standard Deviation 2.3 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: <0.0195% CI: [1.2, 6.9]Mixed Models Analysis
Secondary
Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit
This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit | Baseline: ADHDRS Teacher Total | 32.6 units on a scale | Standard Deviation 8.9 |
| Methylphenidate Transdermal System | Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit | Follow-up: ADHDRS Teacher Total | 28.0 units on a scale | Standard Deviation 14.4 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: >0.1195% CI: [-5.6, 20.7]Mixed Models Analysis
Secondary
Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit
The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit | Baseline: FAM-III Overall | 55.7 units on a scale | Standard Deviation 4.1 |
| Methylphenidate Transdermal System | Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit | Follow-up: FAM-III Overall | 53.5 units on a scale | Standard Deviation 5.2 |
Comparison: Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.p-value: >0.2195% CI: [-2.98, 6.82]Mixed Models Analysis
Secondary
Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit
The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit | Baseline: LPS Total | 26.6 units on a scale | Standard Deviation 9 |
| Methylphenidate Transdermal System | Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit | Follow-up: LPS Total | 39.9 units on a scale | Standard Deviation 12.2 |
Comparison: Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.p-value: <0.00195% CI: [-16.8, -5.4]Mixed Models Analysis
Secondary
Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit
The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit | Baseline: PEDI Self-Care | 28.8 units on a scale | Standard Deviation 7 |
| Methylphenidate Transdermal System | Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit | Follow-up: PEDI Self-Care | 32.5 units on a scale | Standard Deviation 6.5 |
Comparison: Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.p-value: >0.0695% CI: [-7.9, 0.8]Mixed Models Analysis
Secondary
Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit
The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.
Time frame: Baseline, 8 weeks
Population: Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methylphenidate Transdermal System | Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit | Baseline: PEDI Social Function | 9.3 units on a scale | Standard Deviation 5 |
| Methylphenidate Transdermal System | Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit | Follow-up: PEDI Social Function | 14.9 units on a scale | Standard Deviation 5.8 |
Comparison: Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.p-value: <0.0195% CI: [-9.37, -1.18]Mixed Models Analysis