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Study 5 of 594 for search of: | received on or after 01/16/2009 |
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Sponsored by: |
Children's Hospital and Regional Medical Center, Seattle |
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Information provided by: | Children's Hospital and Regional Medical Center, Seattle |
ClinicalTrials.gov Identifier: | NCT00830700 |
While telemental health (TMH) programs are increasing nationally to address the inequity of access to psychiatric services, there are few reports of their efficacy, particularly with children. The current proposal will complete the second stage of our program development. In the first stage, we established the feasibility of a TMH service and its acceptability to families and PCPs. In the second stage of program development we will conduct a randomized clinical trial (RCT) that will determine whether it is possible to use technological advances to: 1) improve clinical outcomes for children with ADHD over outcomes achieved in usual PC; and 2) adhere to an EBT protocol implemented through TMH. Future studies will examine whether other types of complicated psychiatric disorders and EBTs are amenable to delivery via TMH.
The overall goal of this study is to determine whether an evidence-based model of care can be faithfully implemented when delivered using TMH to children with ADHD living in rural areas and can improve outcomes over treatment as usual (TAU) in PC. ADHD is an excellent focus for assessment of TMH, as PCPs encounter this disorder frequently, EBT guidelines are available, pharmacotherapy is the core treatment and is easily delivered in PC through videoconferencing, and stabilization may be readily achieved for most youth.
Condition | Intervention |
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Attention Deficit Disorder With Hyperactivity |
Other: CATMH intervention |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas |
Estimated Enrollment: | 250 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CATMH intervention: Experimental
Child and adolescent telemental health service delivery intervention
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Other: CATMH intervention
This intervention is comprised of 6-tandem-sessions of pharmacotherapy and a behavioral intervention conducted over 4-5 months. The telepsychiatrist and the local primary care physician (PCP) make prescribing decisions and the PCP prescribes the medication, following evidence-based practice. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by trained therapists at each participating clinic. The 6-session behavioral intervention consists of: 1) parent education about how neurobiological deficits of ADHD relate to observed behavioral difficulties; 2)approaches to manage children's behaviors and help them to become "self-managers"; and 3) coordination with schools and other community agencies to advocate for the child.
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augmented TAU/PCP: No Intervention
Augmented treatment as usual with primary care physician
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Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathleen Myers, MD, MPH, MS | 206-987-1663 | kathleen.myers@seattlechildrens.org |
Contact: Nancy Palmer, PhD | 206-884-1844 | nancy.palmer@seattlechildrens.org |
United States, Washington | |
Children's Hospital and Regional Medical Center | |
Seattle, Washington, United States, 98105 |
Principal Investigator: | Kathleen Myers, MD, MPH, MS | Children's Hospital and Regional Medical Center |
Study Director: | Ann Vander Stoep, PhD | University of Washington |
Study Director: | Elizabeth McCauley, PhD | University of Washington; Children's Hospital and Regional Medical Center |
Study Director: | Wayne Katon, MD | University of Washington |
Study Director: | Carolyn McCarty, PhD | University of Washington |
Responsible Party: | Children's Hospital and Regional Medical Center, Seattle ( Kathleen Myers, MD, MPH ) |
Study ID Numbers: | 12537, R01MH081997 NIMH |
Study First Received: | January 27, 2009 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00830700 |
Health Authority: | United States: Institutional Review Board |
ADHD telemental health TMH telepsychiatry rural mental health services for children |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Pathologic Processes Disease Nervous System Diseases |