RECRUITING

Evaluating Treatment of ADHD in Children With Down Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD. The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.

Official Title

Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome

Quick Facts

Study Start:2020-10-02

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04219280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, between the ages of 6.00-17.99 years at the time of consent. * Able to take oral (liquid) medication. * English is primary language. * Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS * Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)	* Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for \>/= 3 days prior to starting the study. * Children with psychoses or bipolar disorder based on diagnostic interview with the parent. * Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function. * Specific heart conditions including the following: 1. QTc on baseline ECG\>470ms or QTC \> 500 in patients with repaired CHD, as determined by ECG 2. Brugada pattern, as determined by ECG 3. Baseline heart rate or systolic blood pressure \> 2 SD above mean for age as determined by medical examination. 4. 2nd or 3rd degree AV block, as determined by ECG 5. History of aborted sudden cardiac death or unexplained syncope as determined by medical history 6. History of a single ventricle as determined by medical history 7. Valvular regurgitation or stenosis \> mild, as determined by ECHO 8. Moderate or greater ventricular dysfunction, as determined by ECHO 9. Pulmonary hypertension, defined as right ventricular pressure \>33% systemic pressure or septal position consistent with \>mild right ventricular hypertension, as determined by ECHO 10. Use of a pacemaker as determined by medical history 11. Wolff Parkinson White/pre-ventricular excitation, as determined by ECG 12. Atrial, junctional, or ventricular tachyarrhythmia, as determined by ECG 13. Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), as determined by ECG 14. Abnormal T waves with inversion in V5 and/or V6, bizarre T wave morphology, notched biphasic T waves, or ST segment depression suggesting ischemia or inflammation, as determined by ECG 15. Moderate or larger atrial septal defect, as determined by ECHO 16. Ventricular septal defect \> small by ECHO 17. Valvar stenosis \> mild by ECHO 18. Aortic root dilation \> 2SD above mean by ECHO. * If participants meet any of the following heart conditions, they must be evaluated for the study by a cardiologist before beginning: 1. Right ventricular enlargement/right axis deviation, as determined by ECG 2. Intraventricular conduction delay \>120ms in child \>12 years old or \>100ms in child \<8 years old, as determined by ECG 3. Right or left bundle branch block, as determined by ECG * Treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days. * Active titration of non-ADHD, non-MAO psychotropic medication. Stable use of non-ADHD, non-MAO psychotropic medication, defined by no dose changes for \>/= 4 weeks before starting the study medication trial, will be allowed. * Known hypersensitivity or allergic reactions to methylphenidate or product components such as banana (due to bananas serving as flavoring in the formulation of the project's study interventions - Quillivant XR and the placebo). * Severe Obstructive Sleep Apnea (OSA) as rated by McGill index of 4 * Pregnancy. (Since there is limited information regarding the safety of Quillivant XR during pregnancy, a pregnancy test will be conducted at the medical screen for female participants who have commenced the menstrual cycle. If pregnancy is indicated, the participant will be excluded from the study as a precautionary measure).

Inclusion Criteria

Exclusion Criteria

* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, between the ages of 6.00-17.99 years at the time of consent.
* Able to take oral (liquid) medication.
* English is primary language.
* Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
* Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)

* Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for \>/= 3 days prior to starting the study.
* Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
* Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function.
* Specific heart conditions including the following:
1. QTc on baseline ECG\>470ms or QTC \> 500 in patients with repaired CHD, as determined by ECG
2. Brugada pattern, as determined by ECG
3. Baseline heart rate or systolic blood pressure \> 2 SD above mean for age as determined by medical examination.
4. 2nd or 3rd degree AV block, as determined by ECG
5. History of aborted sudden cardiac death or unexplained syncope as determined by medical history
6. History of a single ventricle as determined by medical history
7. Valvular regurgitation or stenosis \> mild, as determined by ECHO
8. Moderate or greater ventricular dysfunction, as determined by ECHO
9. Pulmonary hypertension, defined as right ventricular pressure \>33% systemic pressure or septal position consistent with \>mild right ventricular hypertension, as determined by ECHO
10. Use of a pacemaker as determined by medical history
11. Wolff Parkinson White/pre-ventricular excitation, as determined by ECG
12. Atrial, junctional, or ventricular tachyarrhythmia, as determined by ECG
13. Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), as determined by ECG
14. Abnormal T waves with inversion in V5 and/or V6, bizarre T wave morphology, notched biphasic T waves, or ST segment depression suggesting ischemia or inflammation, as determined by ECG
15. Moderate or larger atrial septal defect, as determined by ECHO
16. Ventricular septal defect \> small by ECHO
17. Valvar stenosis \> mild by ECHO
18. Aortic root dilation \> 2SD above mean by ECHO.
* If participants meet any of the following heart conditions, they must be evaluated for the study by a cardiologist before beginning:
1. Right ventricular enlargement/right axis deviation, as determined by ECG
2. Intraventricular conduction delay \>120ms in child \>12 years old or \>100ms in child \<8 years old, as determined by ECG
3. Right or left bundle branch block, as determined by ECG
* Treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days.
* Active titration of non-ADHD, non-MAO psychotropic medication. Stable use of non-ADHD, non-MAO psychotropic medication, defined by no dose changes for \>/= 4 weeks before starting the study medication trial, will be allowed.
* Known hypersensitivity or allergic reactions to methylphenidate or product components such as banana (due to bananas serving as flavoring in the formulation of the project's study interventions - Quillivant XR and the placebo).
* Severe Obstructive Sleep Apnea (OSA) as rated by McGill index of 4
* Pregnancy. (Since there is limited information regarding the safety of Quillivant XR during pregnancy, a pregnancy test will be conducted at the medical screen for female participants who have commenced the menstrual cycle. If pregnancy is indicated, the participant will be excluded from the study as a precautionary measure).

Contacts and Locations

Study Contact

Emily K Hoffman, MEd

CONTACT

513-803-3641

Emily.Hoffman1@cchmc.org

Principal Investigator

Anna Esbensen, PhD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Tanya Froehlich, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Kathleen Angkustsiri, MD

PRINCIPAL_INVESTIGATOR

University of California Davis MIND Institute

Study Locations (Sites)

University of California Davis MIND Institute

Sacramento, California, 95817

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Anna Esbensen, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
Tanya Froehlich, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
Kathleen Angkustsiri, MD, PRINCIPAL_INVESTIGATOR, University of California Davis MIND Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-02

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-10-02

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Down Syndrome
ADHD