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| Descriptive Information Fields | |||||
| Brief Title † | Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children | ||||
| Official Title † | ADHD Symptoms in Autism: Cognition, Behavior, Treatment | ||||
| Brief Summary | This study will first examine the cognitive and behavioral differences in children who have an autism spectrum disorder (ASD) and who do and do not have additional symptoms of attention deficit hyperactivity disorder (ADHD). The study will then examine the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children with both ASD and ADHD. |
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| Detailed Description | Attention Deficit Hyperactivity Disorder (ADHD) is a major comorbid psychiatric disorder in children with Autism Spectrum Disorders (ASD) that significantly undermines behavioral, social, and emotional adjustment. Although the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) does not specifically allow for a comorbid diagnosis of ADHD with ASD, many children with an ASD manifest symptoms of ADHD and are treated for it with stimulants or other medication. The few studies on ADHD in ASD have not consistently established its cognitive and behavioral manifestations, or the optimal parameters for treatment. The proposed project will address these issues through studies of cognitive and behavioral functioning in children with ASD, with and without ADHD, and through a study of medication treatment of ADHD symptoms in autism. Two groups of participants between the ages of 7 to 12 will participate in the initial phase of the study to examine the differences in children who have an Autism Spectrum Disorder with or without additional symptoms of ADHD. In one group, participants will qualify for a diagnosis of an Autism Spectrum Disorder (Autistic Disorder, Asperger's Disorder, and Pervasive Developmental Disorder-Not Otherwise Specified) and will also have symptoms of ADHD (ASD/ADHD), while in the second group, participants will have an Autism Spectrum Disorder, without symptoms of ADHD (ASD/non-ADHD group). All participants will undergo an initial psychological testing session that includes standardized measures of intellectual, adaptive behavior, language, behavioral, and emotional functioning, along with standardized diagnostic measures to confirm their diagnoses of ASD and/or ADHD (Visit 1). Children with intelligence quotients (IQs) below 50 or greater than 130 or with major sensory, motor, neurological, genetic, or psychiatric disorders that may interfere with testing will be excluded. The participants who meet eligibility criteria will complete computerized tasks of attentional functioning in a second visit (Visit 2). A subset of the children from the ASD/ADHD group (N=24) will be invited to participate in a six-week randomized double-blind, placebo-controlled treatment trial using various doses (low, medium, or high dose) of methylphenidate (MPH). Children who are invited to participate in the treatment trial will be those who qualified based on the initial phase and who do not have any physical contraindications to MPH (e.g., history of MPH intolerance). In each week of the treatment trial, the child will take one of the three doses of MPH or a placebo. At the end of each week the child will be brought into the clinic by the parent for a medical check-up, parent interviews about the child's behavior and functioning that week, and computerized cognitive testing. Additionally, the child's parent and teacher will be asked to complete questionnaires about the child's behavior each week, so that the child's home and school behaviors at each MPH dose can be assessed. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Conners' Teacher Rating Scale-Revised (CTRS-R) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Continuous Performance Test (CPT) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Matching Familiar Figures Test (MFFT) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Speeded Classification Task (SCT) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Delay of Gratification Task (DOG) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Conners' Parent Rating Scale (CPRS)-Short Form [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Side Effects Questionnaire-Parent Version [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: Yes ] Aberrant Behavior Checklist [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] ADDH Comprehensive Teacher Rating Scale [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Side Effects Questionnaire-Teacher Version [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: Yes ] Clinician ratings on the Clinical Global Impressions Scale [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Selective Listening Tasks (pediatric speech intelligibility and dichotic listening tasks) [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] Stop Signal Test [ Time Frame: Measured at study entry and at each week of the drug trial ] [ Designated as safety issue: No ] |
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| Condition † | Autism Attention Deficit Disorder With Hyperactivity |
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| Intervention † | Drug: Methylphenidate-extended release Drug: Methylphenidate-instant release Other: Placebo |
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| MEDLINE PMIDs | |||||
| Links | Click here for more information on this study on the Clinic Website ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 72 | ||||
| Start Date † | September 2005 | ||||
| Completion Date | May 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria: Autism/ADHD Group:
Autism/non-ADHD Group:
Exclusion Criteria: In both groups, exclusion criteria will include:
In the autism/ADHD group, further exclusion criteria apply to the MPH trial:
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| Gender | Both | ||||
| Ages | 7 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00178503 | ||||
| Organization ID | R01 MH72263 | ||||
| Secondary IDs †† | DDTR B2-NDA | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | January 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | July 2, 2008 | ||||