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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00699205 |
This study will evaluate the effectiveness of the medication atomoxetine, with and without parent management training, in treating children with autism or pervasive developmental disorder not otherwise specified who have symptoms of attention deficit hyperactivity disorder.
Condition | Intervention | Phase |
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Autism Attention Deficit Disorder With Hyperactivity |
Drug: Atomoxetine Behavioral: Parent management training (PMT) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Atomoxetine, Placebo, and Parent Training in Autism |
Estimated Enrollment: | 156 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive treatment with atomoxetine plus parent management training.
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Drug: Atomoxetine
Child participants will take atomoxetine twice a day for 10 weeks. The dose will be increased gradually for the first 6 weeks, based on the child's response to side effects. If the child shows improvement after the initial 10 weeks of treatment, atomoxetine treatment will be continued twice daily for 24 more weeks.
Behavioral: Parent management training (PMT)
PMT will include individual parent sessions held weekly for 10 weeks. Some sessions will include both parent and child. Sessions will include parenting instruction, practice activities, behavior rehearsal with feedback from the behavior therapist, and role-playing of specific skills. If child participants show improvement after the initial 10 weeks of treatment, monthly PMT sessions will continue for 24 more weeks.
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2: Active Comparator
Participants will receive treatment with atomoxetine only.
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Drug: Atomoxetine
Child participants will take atomoxetine twice a day for 10 weeks. The dose will be increased gradually for the first 6 weeks, based on the child's response to side effects. If the child shows improvement after the initial 10 weeks of treatment, atomoxetine treatment will be continued twice daily for 24 more weeks.
|
3: Placebo Comparator
Participants will receive treatment with placebo plus parent management training.
|
Behavioral: Parent management training (PMT)
PMT will include individual parent sessions held weekly for 10 weeks. Some sessions will include both parent and child. Sessions will include parenting instruction, practice activities, behavior rehearsal with feedback from the behavior therapist, and role-playing of specific skills. If child participants show improvement after the initial 10 weeks of treatment, monthly PMT sessions will continue for 24 more weeks.
Drug: Placebo
Child participants will take placebo twice a day for 10 weeks. If the child shows improvement after the initial 10 weeks of treatment, placebo treatment will be continued twice daily for 24 more weeks.
|
4: Placebo Comparator
Participants will receive treatment with placebo only.
|
Drug: Placebo
Child participants will take placebo twice a day for 10 weeks. If the child shows improvement after the initial 10 weeks of treatment, placebo treatment will be continued twice daily for 24 more weeks.
|
Autism and pervasive developmental disorder not otherwise specified (PDDNOS), an autism spectrum disorder, are brain development disorders characterized by abnormalities in communication, social interactions, and range of interests. Overactivity and inattention, both symptoms of attention deficit hyperactivity disorder (ADHD), are commonly reported among children with autism. Recent data have suggested that at least 14% of children with autism are treated for ADHD symptoms, typically with stimulant medication. However, response rates to stimulant medication are poorer among children with autism than among typically developing children with ADHD, suggesting a substantial need for potential alternative treatment options. Previous studies have shown that training programs that teach parents ways to address adaptive behavior and behavioral problems can be effective in improving symptoms of autism and ADHD in children. Parent training, in combination with the nonstimulant ADHD medication atomoxetine, may be the best way to improve emotional and attention-related problems in children with autism and ADHD. This study will evaluate the effectiveness of the medication atomoxetine, with and without parent management training (PMT), in treating children with autism or PDDNOS who have symptoms of ADHD.
Participation in this study will last 9 months and will include two phases. Phase 1 will last 12 weeks. After screening, all eligible child participants will undergo baseline assessments that will include tests of attention and/or memory on a computer system, vital sign measurements, and a review of past medications. Parent participants will also complete questionnaires about their child's behavior and symptoms and a review of any previous parent training experiences.
Participants will then be assigned randomly to one of four treatment groups: atomoxetine plus PMT, atomoxetine alone, placebo plus PMT, or placebo alone. Child participants will take their assigned study medication twice daily for 10 weeks and will attend weekly clinic visits. During these visits, child participants will undergo vital sign measurements, possible medication adjustments, and some of the baseline learning testing. Parent participants will be asked questions about their child's side effects and behavior. Participants assigned to also receive PMT will individually meet with a clinician weekly for 10 weeks. The sessions involving a parent and child or parent alone will include parenting instruction, practice activities, behavior rehearsal with feedback from the behavior therapist, and role-playing of specific skills. Parents will also be given at-home homework assignments that will involve practicing techniques learned in sessions and collecting information on their child's behavior. At the end of Phase 1, all participants will repeat the baseline assessments and children will undergo a physical exam.
Any child participants who have shown improvement after Phase 1 will be invited to participate in Phase 2, which will last 24 weeks. Child participants will continue to take their assigned medications from Phase 1 and, if applicable, will continue PMT sessions once a month. They will attend 6 monthly clinic visits that will involve the same procedures conducted in Phase 1 visits. Upon completing the 24 additional weeks of treatment, all participants will undergo repeat baseline assessments.
Ages Eligible for Study: | 5 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Carol Stamm, BA 585-275-0953 Carol_stamm@urmc.rochester.edu | |
Contact: Tristram Smith, PhD 585-273-3515 Tristram_smith@urmc.rochester.edu | |
Principal Investigator: Tristram Smith, PhD | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Michael Aman, PhD 614-688-4196 aman.1@osu.edu | |
Contact: Jill Hollway 614-247-6402 jill.hollway@osumc.edu | |
Principal Investigator: Michael Aman, PhD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Benjamin Handen, PhD 412-235-5445 Handenbl@msx.upmc.edu | |
Contact: Sarah McAuliffe-Bellin 412-235-5447 mcauliffebellinsj@upmc.edu | |
Principal Investigator: Benjamin Handen, PhD |
Principal Investigator: | Benjamin Handen, PhD | University of Pittsburgh |
Principal Investigator: | Michael Aman, PhD | Ohio State University |
Principal Investigator: | Tristram Smith, PhD | University of Rochester |
Responsible Party: | University of Rochester ( Tristram Smith, MD, Site PI ) |
Study ID Numbers: | R01 MH079082, DDTR B2-NDA |
Study First Received: | June 13, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00699205 |
Health Authority: | United States: Food and Drug Administration |
PDDNOS ADHD Parent Management Training |
Strattera Atomoxetine Autism |
Developmental Disabilities Child Development Disorders, Pervasive Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Atomoxetine Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |