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Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found that daily stimulant therapy produced sustained growth deficits. However, no federally funded studies have examined the growth suppression associated with modern once a day stimulant medications. Therefore, this study will precisely estimate the risks of stimulant induced growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it. While drug holidays and caloric supplementation are two common treatments for SIGS, there has been little systematic investigation of either. It is unknown if they are effective or feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal children with ADHD. An additional 50 subjects will be treated solely with behavioral therapies to evaluate for growth abnormalities associated with ADHD. The study will assess will the risk of SIGS with ER stimulants and the underlying mechanisms while providing evidenced-based treatments for its management.
The study will consist of 4 parts:
A) Extra monitoring: A doctor will check the child's growth every month (instead of every 3 months) until his/her BMI has returned to normal.The child will stay on the current daily dose of medication or behavior therapy.
B) Caloric supplementation: Parents will be provided with a flavored calorie drink to give to your child every night and continue on the same daily dose and frequency of medication or behavior therapy. The child will have their growth monitored monthly by a study doctor.
C) Drug Holiday: Participants will now only take medication on school days. Children assigned to behavior therapy will not participate in this treatment as they are not taking any study medication. The child will have their growth monitored monthly by a study doctor.
Once the child's weight recovers, these extra treatments will end and he/she will return to the prior medication treatment (medication7 days a week or behavior therapy) in step 3 and to every 3 month growth assessments. Any time the child's BMI declines again, the extra treatments will restart again.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| weight recovery treatment- monitoring | Active Comparator | Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the monitoring arm , participants will continue on their ER stimulant 7 days a week and have their weight, height and BMI checked monthly. |
|
| behavior therapy | Active Comparator | 10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject |
|
| ER stimulant | Experimental | daily use of 12 hour extended release methylphenidate product |
|
| weight recovery treatment- caloric supplement | Experimental | Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the caloric supplement arm, participants will continue on their ER stimulant 7 days a week, have their weight, height and BMI checked monthly and be prescribed a 150 kcal caloric supplement to be consumed every evening. |
|
| weight recovery treatment- drug holiday |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavior therapy | Behavioral | combination of individual and group parent training plus school consultation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change Score for Z-height Baseline to Endpoint | The primary endpoint will be change in z-height at month 30 which is study endpoint. Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time. | month 30 or last assessment point |
| Measure | Description | Time Frame |
|---|---|---|
| Change Score for z Weight | difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time. | baseline to month 30 or to last assessment point |
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Inclusion Criteria:
Exclusion Criteria:
Children who meet any of the following criteria will not be eligible to participate in this study:
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| Name | Affiliation | Role |
|---|---|---|
| James G Waxmonsky, MD | Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Children and Families, Florida International University | Miami | Florida | 33199 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34571023 | Derived | Waxmonsky JG, Pelham WE 3rd, Baweja R, Hale D, Pelham WE Jr. Predictors of Changes in Height, Weight, and Body Mass Index After Initiation of Central Nervous System Stimulants in Children with Attention Deficit Hyperactivity Disorder. J Pediatr. 2022 Feb;241:115-125.e2. doi: 10.1016/j.jpeds.2021.09.030. Epub 2021 Sep 25. | |
| 34366928 | Derived | Baweja R, Waschbusch DA, Pelham WE 3rd, Pelham WE Jr, Waxmonsky JG. The Impact of Persistent Irritability on the Medication Treatment of Paediatric Attention Deficit Hyperactivity Disorder. Front Psychiatry. 2021 Jul 21;12:699687. doi: 10.3389/fpsyt.2021.699687. eCollection 2021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavior Therapy | 10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject behavioral therapy: combination of individual and group parent training plus school consultation |
| FG001 | ER Stimulant | daily use of 12 hour extended release (ER) methylphenidate product 12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm |
| FG002 | Caloric Supplementation | Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks, continuation of a daily extended release stimulant and the addition of a liquid 8oz caloric supplement every evening. |
| FG003 | Drug Holiday | Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and limiting CNS stimulant medication to school days only. |
| FG004 | Monitoring | Subjects in either the behavior therapy arm or the medication arm who met criteria for weight recovery were randomly assigned to 1 of 3 weight recovery treatments. This arm consisted of monthly weight checks and continuation of daily extended release stimulant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Randomization: ADHD Treatment |
|
| ||||||||||||||||||
| Adaptive Randomization: Weight Recovery |
|
all participants assigned to treatment Note that initial randomization was to med or behavior. Those meeting criteria were then adaptively rerandomized to 1 of 3 weight recovery arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavior Therapy | 10 week basic parent training, advanced 8 week parent training course. monthly boosters, option for individual parent training sessions, school consultant assigned to each subject behavioral therapy: combination of individual and group parent training plus school consultation |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Score for Z-height Baseline to Endpoint | The primary endpoint will be change in z-height at month 30 which is study endpoint. Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time. | includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization. See outcome #10 for change in zht from beginning to end of second randomization. | Posted | Mean | Standard Deviation | Z score | month 30 or last assessment point |
|
up to 30 months (max study duration). Population is all participants with at least a baseline side effect rating and at least one additional rating of adverse events post baseline which is 212 cases total. This differs from other enrollment numbers as not all participants assigned to each group completed side effect assessments. We did not want to include missing cases as negative cases (no side effects) as that would impact side effect rates.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavior Therapy | Participants completing a baseline assessment and at least one post baseline assessment of adverse events and were initially assigned to behavior arm which included a basic parenting intervention, additional advanced 8 week parent training intervention, monthly boosters, option for individual parent training sessions, and a school consultant assigned to each subject. Medication usage allowed after month 6 if at least moderately impaired includes all participants with at least one post baseline assessment of adverse events |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| self injurious behavior | Psychiatric disorders | Systematic Assessment | child tried to open door in moving car in attempt to harm self. Did lead to psychiatric hospitalization with no further self harm events. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin picking | Skin and subcutaneous tissue disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Waxmonsky MD | Penn State College of Medicine | 7175318646 | jwaxmonsky@pennstatehealth.psu.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D008774 | Methylphenidate |
| D009720 | Nurse Clinicians |
| D000697 | Central Nervous System Stimulants |
| D000097042 | Treatment Interruption |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
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initial randomization to behavior or extended release stimulant (ER stimulant) arms.
Participants in either arm meting criteria for a weight recovery intervention (based on change in zBMI) will be adaptively randomized to one of three weight recovery arms (Monitoring, Drug Holiday, Caloric Supplementation)
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| Experimental |
Subjects in either the behavior therapy arm or the medication arm will be assigned to one of 3 treatments if subject does not meet projected BMI goals. In the drug holiday arm, participants will only take their ER stimulant on school days a week and have their weight, height and BMI checked monthly. |
|
| Extended release (ER) methylphenidate product | Drug | medication to be taken daily for duration of study unless assigned to weight promotion arm |
|
|
| monitoring | Other | monthly weight, height and BMI checks |
|
|
| drug holiday | Other | switch from seven day a week dosing to medication only on school days |
|
|
| caloric supplement | Dietary Supplement | continue current ADHD regimen and add one 8oz liquid caloric supplement at night |
|
| Change in zBody Mass Index (BMI) | BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time. | baseline to month 30 or last assessment point |
| Treatment Adherence for Caloric Supplement | percent of days caloric supplement were taken versus prescribed in caloric supplement arm | from entry to exit of caloric supplement arm |
| ADHD Symptoms- Parent Rated | sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point. | at month 30 or last collected assessment point |
| Change Score for Zheight Months 0 to 6 | in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication. This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over. Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain. If participant dropped out prior to month 6, then the last assessment point was used. | baseline to month 6 |
| ADHD Symptoms- Teacher Rated | sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point. | month 30 or last assessment point |
| Medication Adherence | % of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm. | denominator is number of days in study for which study med was prescribed |
| Number of Behavior Therapy Sessions | Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm | months 0 through 30 |
| Change in Height z Score During Weight Recovery Phase (Second Randomization) | difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant. Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain. | between 1 month and 24 months |
| Change in Weight z Score During Weight Recovery Phase (Second Randomization) | difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant. Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain. | 1 to 24 months duration |
| Change in Zscore for BMI During Weight Recovery Phase (Second Randomization) | difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant. Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain. | between 1 month and 24 months |
| 31473291 | Derived | Waxmonsky JG, Pelham WE 3rd, Campa A, Waschbusch DA, Li T, Marshall R, Babocsai L, Humphery H, Gnagy E, Swanson J, Hanc T, Fallahazad N, Pelham WE Jr. A Randomized Controlled Trial of Interventions for Growth Suppression in Children With Attention-Deficit/Hyperactivity Disorder Treated With Central Nervous System Stimulants. J Am Acad Child Adolesc Psychiatry. 2020 Dec;59(12):1330-1341. doi: 10.1016/j.jaac.2019.08.472. Epub 2019 Aug 29. |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| move away |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| ER Stimulant |
daily use of 12 hour extended release methylphenidate product 12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| zHeight | Mean | Standard Deviation | Z score |
|
| zWeight | Mean | Standard Deviation | Z score |
|
| zBMI | Mean | Standard Deviation | Z score |
|
| OG001 | ER Stimulant | daily use of 12 hour extended release methylphenidate product 12 hour methylphenidate product: medication to be taken daily for duration of study unless assigned to weight promotion arm |
|
|
| Secondary | Change Score for z Weight | difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time. | includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #11 for change in zwt from beginning to end of second randomization. | Posted | Mean | Standard Deviation | Z score | baseline to month 30 or to last assessment point |
|
|
|
| Secondary | Change in zBody Mass Index (BMI) | BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time. | includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #12 for change in zBMI from beginning to end of second randomization. | Posted | Mean | Standard Deviation | Z score | baseline to month 30 or last assessment point |
|
|
|
| Secondary | Treatment Adherence for Caloric Supplement | percent of days caloric supplement were taken versus prescribed in caloric supplement arm | those assigned to caloric supplement group | Posted | Mean | Standard Deviation | percentage of days | from entry to exit of caloric supplement arm |
|
|
|
| Secondary | ADHD Symptoms- Parent Rated | sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point. | those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization. | Posted | Mean | Standard Deviation | units on a scale | at month 30 or last collected assessment point |
|
|
|
| Secondary | Change Score for Zheight Months 0 to 6 | in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication. This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over. Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain. If participant dropped out prior to month 6, then the last assessment point was used. | participants with at height measurement at month 6 | Posted | Mean | Standard Deviation | Z score | baseline to month 6 |
|
|
|
| Secondary | ADHD Symptoms- Teacher Rated | sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point. | those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization. | Posted | Mean | Standard Deviation | units on a scale | month 30 or last assessment point |
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|
| Secondary | Medication Adherence | % of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm. | any participants with at least one dose of med prescribed. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment. | Posted | Number | % of days dose taken as prescribed | denominator is number of days in study for which study med was prescribed |
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|
|
| Secondary | Number of Behavior Therapy Sessions | Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm | those with at least one follow up assessment. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment. | Posted | Mean | Standard Deviation | sessions attended | months 0 through 30 |
|
|
|
| Secondary | Change in Height z Score During Weight Recovery Phase (Second Randomization) | difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant. Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain. | all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. One monitoring participant never prescribed med was excluded.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI. | Posted | Mean | Standard Deviation | Z score | between 1 month and 24 months |
|
|
|
| Secondary | Change in Weight z Score During Weight Recovery Phase (Second Randomization) | difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant. Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain. | all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI. | Posted | Mean | Standard Deviation | Z score | 1 to 24 months duration |
|
|
|
| Secondary | Change in Zscore for BMI During Weight Recovery Phase (Second Randomization) | difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant. Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain. | all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI. | Posted | Mean | Standard Deviation | Z score | between 1 month and 24 months |
|
|
|
| Post-Hoc | Change in Height z Score by Actual Medication Usage | measures change in height z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used) med for at least 87.5% of their time in the study with most using the entire time. The inconsistent med group (N=111), used medication between 12.5 to 87.5 of the time (mean time on med was 45% of the time in the study) The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. More negative values reflecting a smaller incremental height gain. | Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 1 and 10). | Posted | Mean | Standard Deviation | Z score | baseline to month 30 or last assessment point |
|
|
|
| Post-Hoc | Change in Weight z Score by Actual Medication Usage | measures change in weight z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a greater incremental weight gain. | Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 2 and 11). | Posted | Mean | Standard Deviation | Z score | baseline to month 30 or last assessment point |
|
|
|
| Post-Hoc | Change in BMI z Score by Actual Medication Usage | measures change in BMI z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a larger BMI | Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 3 and 12). | Posted | Mean | Standard Deviation | Z score | baseline to month 30 or last assessment point |
|
|
|
| Post-Hoc | Difference in Height z Score During Weight Recovery Phase (Second Randomization) by Actual Usage | difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change. Z score used to account for differences in age and gender between groups. Larger values reflect greater height change. | all participants using an ER stimulant and were also assigned to a weight recovery arm. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 13. | Posted | Mean | Standard Deviation | Z score | between 1 month and 24 months |
|
|
|
| Post-Hoc | Change in Weight z Score During Weight Recovery Phase (Second Randomization) Based on Actual Usage | difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change. Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental weight gain. | participants using an ER stimualnt and also randomized to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 14. | Posted | Mean | Standard Deviation | zscore | between 1 month and 24 months |
|
|
|
| Post-Hoc | Change in BMI z Score During Weight Recovery Period (Second Randomization) Based on Actual Usage | difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change. Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental BMI increase. | all participants prescribed an ER stimulant and also assigned to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 15. | Posted | Mean | Standard Deviation | Z score | between 1 month and 24 months |
|
|
|
| 0 |
| 41 |
| 2 |
| 41 |
| 33 |
| 41 |
| EG001 | ER Stimulant | Participants completing a baseline assessment and at least one post baseline assessment of adverse events who were initially assigned to daily use of extended release CNS Stimulant All study medication was prescribed to be taken daily for duration of study unless assigned to weight promotion drug holiday arm includes all participants with at least one post baseline assessment of adverse events | 0 | 171 | 3 | 171 | 156 | 171 |
| EG002 | Dose Optimzed | This arm includes the 142 participants that had their dose of study medication systematically optimized through assessment of efficacy and tolerability at home and school. There participants could have come from either of the other two arms- initially assigned to either med or behavior. We added this post hoc arm as a subset of participants randomized to med never used med and a subset of behavior randomized participants did use medication. This group reports adverse event rates only in participants who used med for a sufficient duration to have their dose optimized. | 0 | 136 | 4 | 136 | 125 | 136 |
|
| aggression | Psychiatric disorders | Systematic Assessment | child became defiant towards staff at school and responded with physical aggression when redirected. led to brief psychiatric hospitalization. Event did not recur over course of the study. |
|
| appendicitis | Gastrointestinal disorders | Systematic Assessment | hospitalized for appendectomy |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment | diagnosed with gastroenteritis and hospitalized for one day |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | diagnosed with pneumonia and hospitalized for treatment |
|
|
| buccal movements | Nervous system disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| anxiety | Psychiatric disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| dull, listless | General disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| headache | Psychiatric disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| stomachache | Gastrointestinal disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| irritability | Psychiatric disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| depressed mood | Psychiatric disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| socially withdrawn | Psychiatric disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| loss of appetite | General disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| trouble sleeping | General disorders | Systematic Assessment | measured on Pittsburgh Side Effect Rating Scale |
|
| motor/verbal tics | Nervous system disorders | Systematic Assessment | not including buccal movements |
|
Not provided
Not provided
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000072184 | Nurse Specialists |
| D009726 | Nurses |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000074822 | Treatment Adherence and Compliance |
| D001294 | Attitude to Health |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |