Telepsychiatry in Rural Youth
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 30, 2010 | ||||
| Last Updated Date | March 30, 2010 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Equivalence [ Time Frame: 4/15/2010-9/15/2011 ] [ Designated as safety issue: No ] The number of visits completed by subjects assigned to the telepsychiatry arm will be "equivalent" to the number completed by subjects assigned to the face-to-face arm. Follow-up retention is directly associated with psychiatric outcomes and it is possible that telehealth might be seen by participants as somewhat impersonal. The implication is that retention will be reduced in the telepsychiatry group compared to the face-to-face arm. Retention will be defined as visits from baseline to either drop-out or completion of the four-month f/u study period. Visits occur at monthly intervals. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Non-inferiority [ Time Frame: 4/15/2010-9/15/2011 ] [ Designated as safety issue: No ] Telehealth will be non-inferior to face-to-face services with regard to the change in the inattention component of attention-deficit / hyperactivity disorder symptoms measured at baseline and at the end of the four-month intervention. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Telepsychiatry in Rural Youth | ||||
| Official Title ICMJE | A Randomized Exploratory Study of Telepsychiatry Outcomes in Rural Youth | ||||
| Brief Summary |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | September 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Inclusions: The study will include children with co-occurring psychiatric conditions because of high comorbidity rates in ADHD. Comorbidity is present in as many as two-thirds of children with ADHD, including up to 50% for other disruptive disorders, 15%-20% for mood disorders, 20% to 25% for anxiety disorders, and 15-20% for learning disorders (Dulcan et al., 1997). Thus, with inclusion of children with comorbidity, the findings will have greater generalizability. Additionally, the comorbid children and adolescents are often too complex for primary care treatment and need child psychiatric services. The study will include:
Exclusions: As in Pliszka et al.'s (2003) study of the CMAP ADHD treatment algorithm, only conditions that would prevent treatment for the primary disorder from being effective will be excluded. The study will not include subjects with: Exclusion Criteria:
Children and families who are not English speaking will not be included in the study. |
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| Gender | Both | ||||
| Ages | 6 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01096953 | ||||
| Other Study ID Numbers ICMJE | 1 R21 MH079984-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nancy Winters, M.D., Oregon Health & Science University | ||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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