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Management of ADHD in Autism Spectrum Disorder

Primary Purpose

ADHD, Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
Sponsored by
Daniel Coury
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for ADHD focused on measuring ADHD, Autism, ASD

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient and/or legally authorized representative must be willing and able to give informed consent/assent for participation in this study. Patient and their caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements. Patient must be between 4 and 17 years of age (inclusive) at time of enrollment. Patient must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS (Autism Diagnostic Observation Schedule) or CARS (Childhood Autism Rating Scale), etc.). Patient must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid). Patient must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence). Patient must have a consistent reporter (e.g., parent) who spends regular time with the child. Patient can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for > 4 weeks prior to consent with no plans for a dose change during the study. Patient with prior trial of ADHD medication more than one year before enrollment, based on clinician judgement of reason for prior trial failure. Patient and/or family/caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study. Exclusion Criteria: Patient history of more than one prior trial of an ADHD medication within the past year. Less than 4 weeks since last ADHD medication was taken. Any other risk factor that might prevent patient from safely taking the study medications. There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.

Sites / Locations

  • University of California, Irvine
  • Children's Hospital Los Angeles
  • Maine Medical Center
  • Massachusetts General Hospital Lurie Center for Autism
  • University of Rochester
  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's Hospital
  • Children's Hospital of Philadelphia
  • University of Pittsburgh
  • University of Virginia
  • University of Alberta, Glenrose Rehabilitation Hospital
  • Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stage 1 - Stimulant

Stage 2 - Alpha-2 Agonist or Alternate Stimulant

Arm Description

This proposed naturalistic, pragmatic clinical trial does not involve investigational drugs. Sequential, multiple assignment randomized trial (SMART) pragmatic clinical trial. Stage 1 - randomization to either Amphetamine (AMP) or Methylphenidate (MPH). The specific medication prescribed by the physician will be determined by discussion between physician and parent / caregiver and review of the subject's insurance coverage. Subjects will receive their medication from their pharmacy.

Stage 2 - randomization to either Alpha-2 Agonist or other stimulant not randomized to in Stage 1: Amphetamine (AMP) or Methylphenidate (MPH). (frequency, dosage, format, and duration dependent on participant and study doctor discussion).

Outcomes

Primary Outcome Measures

The Vanderbilt Parent Rating Scale
The primary outcome measure is The Vanderbilt Parent Rating Scale for ADHD consists of 18 item, each scored from 0 to 3. It has a minimum score of 0, maximum score of 54. Higher scores indicate worse outcome.

Secondary Outcome Measures

Parent reported Clinical Global Impression
Parent reported Clinical Global Impression - Improvement is a Likert scale ranging from 1 to 7. Higher scores indicate worse outcome.
Aberrant Behavior Checklist- Hyperactivity/Impulsivity subscale
Aberrant Behavior Checklist- Hyperactivity/Impulsivity subscale consists of 16 items, each scored from 0 to 3. It has a minimum score of 0, maximum score of 48. Higher scores indicate worse outcome.

Full Information

First Posted
May 31, 2023
Last Updated
June 14, 2023
Sponsor
Daniel Coury
Collaborators
Patient-Centered Outcomes Research Institute, University of California, Irvine, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Philadelphia, University of Rochester Golisano Children's Hospital, Nationwide Children's Hospital, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, Children's Hospital Los Angeles, University of Virginia, University of Alberta, Massachusetts General Hospital, MaineHealth, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05916339
Brief Title
Management of ADHD in Autism Spectrum Disorder
Official Title
Efficacy of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Coury
Collaborators
Patient-Centered Outcomes Research Institute, University of California, Irvine, Holland Bloorview Kids Rehabilitation Hospital, Children's Hospital of Philadelphia, University of Rochester Golisano Children's Hospital, Nationwide Children's Hospital, Children's Hospital Medical Center, Cincinnati, University of Pittsburgh, Children's Hospital Los Angeles, University of Virginia, University of Alberta, Massachusetts General Hospital, MaineHealth, University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.
Detailed Description
Current data shows that 1 in 54 children in the United States are diagnosed with autism spectrum disorder (ASD). Additional data shows that those diagnosed with autism are also at risk for being diagnosed with a co-occurring condition such as attention deficit/hyperactivity disorder (ADHD). Managing the symptoms of each can be challenging for providers, patients, and parents. Patients with ASD who are diagnosed with ADHD often face the challenge of finding the best medication options to treat symptoms. It is known that children with ASD and ADHD frequently respond differently to these treatments than typically developing (TD) children. Currently, no clear recommendations exist for parents or providers to follow to guide best medication options for patients with ASD and ADHD. This lack of medication knowledge and suboptimal medication management can lead to poor results and have substantial negative life impact for patients and their families. The main goal of this study is to determine if the most prescribed medications for ADHD in TD children are similarly effective for patients who also have a diagnosis of autism. The results of this study will improve provider understanding of first-line stimulant medicines, methylphenidate and amphetamine compound, with ASD patients. Parents will determine medication effectiveness through discussion with their child and with their doctor as well as their own observations and will drive the medication adjustment process. Parents will provide ratings of effectiveness using the Clinical Global Impression measure every two weeks and the Aberrant Behavior Checklist and the Vanderbilt Parent Rating Scale will be completed monthly. For those patients who do not respond to first-line medicines, this study will further develop the understanding of second-line medication options, the alpha2 agonists guanfacine and clonidine. Parents will provide ratings using the same measures as before. Additional study measures will collect and review parent/caregiver input in the process of determining medication continuation. Most measures will be completed through electronic portals, reducing the need for families to come to the hospital to participate in this study. While these medications are routinely prescribed to treat ADHD in children and adolescents with ASD, their relative effectiveness is not known. Randomizing participants to these different medicines in this format, called a SMART (Sequential Multiple Assignment Randomization Trial) design, will provide data on how well these medications work in children with ASD and ADHD, how they work compared to each other, and how their side effects differ from use in TD children. This study will also examine the effect of these medicines on target problems identified by parents, such as oppositional behavior. Parents/caregivers will be a significant part of the data and input captured to determine if medication should continue or be discontinued. The care team of patient, parent, and provider is solid in this project and will lead to optimal decision pathways for future patients with autism. The aims outlined in this study are beneficial to patients with autism and their families/caregivers who often help navigate health care with them for life. Having access to evidence-based best practices when making medication decisions can impact and expedite positive outcomes in managing the symptoms of ADHD. When symptoms are managed at optimal levels, patients can focus on building life skills and accessing opportunities toward meaningful life outcomes. Coproduced with parents and providers, this study is designed to reduce the trial and error aspect of prescribing ADHD medications and build provider and parent knowledge in best practice. The patient and family voice are an integral part of the study design process. This coproduction of treatment evidence helps ensure best outcomes for the patient and is supported by the inclusion of stakeholders. Participants will be children 4 to 17 years of age recruited from The Autism Care Network, the first and only network of its kind focused on better autism care, delivered at scale and at speed, to improve health and quality of life for children with autism and their families throughout North America. Twelve of the 20 network sites will participate in this study, each with providers and patients' parents committed to ensuring more than 500 patients will be part of this study and who are also committed to continuously improving whole-person and whole-family autism care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Autism Spectrum Disorder
Keywords
ADHD, Autism, ASD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 - Stimulant
Arm Type
Active Comparator
Arm Description
This proposed naturalistic, pragmatic clinical trial does not involve investigational drugs. Sequential, multiple assignment randomized trial (SMART) pragmatic clinical trial. Stage 1 - randomization to either Amphetamine (AMP) or Methylphenidate (MPH). The specific medication prescribed by the physician will be determined by discussion between physician and parent / caregiver and review of the subject's insurance coverage. Subjects will receive their medication from their pharmacy.
Arm Title
Stage 2 - Alpha-2 Agonist or Alternate Stimulant
Arm Type
Active Comparator
Arm Description
Stage 2 - randomization to either Alpha-2 Agonist or other stimulant not randomized to in Stage 1: Amphetamine (AMP) or Methylphenidate (MPH). (frequency, dosage, format, and duration dependent on participant and study doctor discussion).
Intervention Type
Drug
Intervention Name(s)
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Intervention Description
Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid)
Intervention Type
Drug
Intervention Name(s)
Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
Intervention Description
If first line stimulant therapy (Amphetamine/Methylphenidate) is deemed not effective or tolerable, re-randomization to the alternate stimulant or alpha-2 agonist will occur. If participant is satisfied with first line stimulant treatment, first-line stimulant therapy will continue. Catapres, Clonidine, Guanfacine, Intuniv, Kapvay, Tenex
Primary Outcome Measure Information:
Title
The Vanderbilt Parent Rating Scale
Description
The primary outcome measure is The Vanderbilt Parent Rating Scale for ADHD consists of 18 item, each scored from 0 to 3. It has a minimum score of 0, maximum score of 54. Higher scores indicate worse outcome.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Parent reported Clinical Global Impression
Description
Parent reported Clinical Global Impression - Improvement is a Likert scale ranging from 1 to 7. Higher scores indicate worse outcome.
Time Frame
16 Weeks
Title
Aberrant Behavior Checklist- Hyperactivity/Impulsivity subscale
Description
Aberrant Behavior Checklist- Hyperactivity/Impulsivity subscale consists of 16 items, each scored from 0 to 3. It has a minimum score of 0, maximum score of 48. Higher scores indicate worse outcome.
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient and/or legally authorized representative must be willing and able to give informed consent/assent for participation in this study. Patient and their caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements. Patient must be between 4 and 17 years of age (inclusive) at time of enrollment. Patient must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS (Autism Diagnostic Observation Schedule) or CARS (Childhood Autism Rating Scale), etc.). Patient must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid). Patient must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence). Patient must have a consistent reporter (e.g., parent) who spends regular time with the child. Patient can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for > 4 weeks prior to consent with no plans for a dose change during the study. Patient with prior trial of ADHD medication more than one year before enrollment, based on clinician judgement of reason for prior trial failure. Patient and/or family/caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study. Exclusion Criteria: Patient history of more than one prior trial of an ADHD medication within the past year. Less than 4 weeks since last ADHD medication was taken. Any other risk factor that might prevent patient from safely taking the study medications. There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aria Dockham, MACPR
Phone
614-722-0723
Email
Aria.Dockham@nationwidechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Coury, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Kuhlthau, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Cadondon
Phone
949-267-0491
Email
scadondo@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Peter Chung, MD
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Anaya
Email
granaya@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Smith, RN, MN, DrPH
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milleah Sawtelle
Phone
207-661-6032
Email
milleah.sawtelle2@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Matthew Siegel, MD
Facility Name
Massachusetts General Hospital Lurie Center for Autism
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Brooks
Phone
781-860-1714
Email
hhbrooks2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ann Neumeyer, MD
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Wagner
Email
Emily_wagner@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Lynn Cole, DNP
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnny Dudley
Phone
614-355-7584
Email
Johnny.Dudley@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Eric Butter, PhD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19178
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15262
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Darring
Phone
434-982-3673
Email
jgd7s@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Richard Stevenson, MD
Facility Name
University of Alberta, Glenrose Rehabilitation Hospital
City
Edmonton
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Mah
Phone
780-735-8285
Email
shannon.mah@ahs.ca
First Name & Middle Initial & Last Name & Degree
Lonnie Zwaigenbaum, MD
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Rombos
Phone
416-425-6220
Ext
3474
Email
vrombos@hollandbloorview.ca
First Name & Middle Initial & Last Name & Degree
Danielle Baribeau, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.
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Management of ADHD in Autism Spectrum Disorder

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