Telepsychiatry in Rural Youth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01096953|
Recruitment Status : Unknown
Verified March 2010 by Oregon Health and Science University.
Recruitment status was: Not yet recruiting
First Posted : March 31, 2010
Last Update Posted : March 31, 2010
It is difficult to offer kids who live in rural areas good psychiatric care. There are only about 7000 psychiatrists for kids (pediatric psychiatrists) in the entire country. When adding nurse practitioners who specialize in mental health care for children, there still are not enough for everyone who needs care. This means either delays in treatment or no treatment at all by these important specialists. The purpose of this study is to explore how the investigators might offer psychiatric care to kids who live in rural areas through the use of telepsychiatry (TP), specifically those with attention deficit/hyperactivity disorder (ADHD).
TP is a way for a physician to talk to someone in a remote area using a computer. The investigators will split the subjects into two study groups. As subjects are identified, they will be assigned a screening number according to a randomization table. The investigators will use TP for one group and face-to-face (F2F) care for the other group. The computer will allow the physician to look at and talk with the child and their parent(s). The investigators would like to know if TP is as good as, or nearly as good as F2F care, so the only difference in treatment approach between the two groups will be whether the subject is receiving treatment through TP or F2F care. Treatment is standardized using a flow chart called the Children's Medication Algorithm Project (CMAP) algorithm. The CMAP algorithm is a guideline established by a large number of experts who have agreed on the best approach to treatment based on scientific evidence. If TP proves as good as F2F care, it would help many parents and their children who do not live in or near a large city.
- The investigators will find study subjects when parents seek care at clinics in rural Oregon. The physicians in those locations will be aware of the study and will tell us when they think someone needs specialized mental health professional (either a pediatric psychiatrist or nurse practitioner with extensive experience in pediatric mental health). The investigators will make sure that ADHD is the right diagnosis using special exams that have been well-tested to show that they are reliable.
The first visit—the intake visit—will probably take about an hour. At that visit, mental health professional will determine whether or not the patient is a candidate for the study. If the patient agrees, they will be asked to sign consent and child assent. The parent and child will then be given an exam that will confirm the diagnosis of ADHD. If confirmed, subjects will then learn if they have been assigned to the TP group or the F2F group and will be assigned to the treating mental health professional. In addition to the DISC, after consent the parent will be given several study instruments to take home with them. They will take about an hour altogether to complete.
The first visit with the treating mental health professional will take about one hour and the three following visits will take about 30 minutes each. These visits will be about six weeks apart. At the third follow-up visit—the final visit—the parents will be again asked to complete the instruments they completed after consent and will be asked to complete a brief questionnaire that will give them the opportunity to describe their satisfaction or dissatisfaction with the treatment and care they received.
Teachers will be asked to complete the Conner's 10-Item Global Index for the subject twice over the course of the study. The parent of the subject will present the scale to the teacher and retrieve the scale in a sealed envelope to return to the clinic.
- The diagnosis for ADHD will be made using an exam called the Diagnostic Interview Schedule for Children Version IV (DISC IV). This is a 90-minute exam that is done with a computer that helps you know what questions to ask and helps record the responses. The parents will also be asked to complete a few instruments and surveys that help us understand how well treatment is working. The investigators expect these exams to take about half an hour to complete. They contain questions about the subject's behavior and are completed by parents, except one brief instrument that the investigators will ask and teachers to complete before each follow-up visit. These instruments take about 10 minutes each to complete.
- This is an initial "pilot" study, so the information collected will mainly offer a better understanding of whether or not a larger study is possible. The investigators will look at how many subjects stayed in the study or dropped out and when they dropped out. The investigators will also look at the exams, scoring them to help us understand if those who were part of the TP group did as well, or nearly as well, as those in the F2F group.
|Condition or disease||Intervention/treatment|
|Attention Deficit Hyperactivity Disorder||Behavioral: Mental health care implemented by telepsychiatry Behavioral: Face-to-face care|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Exploratory Study of Telepsychiatry Outcomes in Rural Youth|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
Active Comparator: Telepsychiatry
Psychiatry provided over telehealth network
Behavioral: Mental health care implemented by telepsychiatry
Care of 6-17 year-olds with ADHDBehavioral: Face-to-face care
Psychiatry provided for treatment of ADHD face-to-face in office
Active Comparator: Face-to-face care
Psychiatry provided in person
Behavioral: Face-to-face care
Psychiatry provided for treatment of ADHD face-to-face in office
- Equivalence [ Time Frame: 4/15/2010-9/15/2011 ]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.
- Non-inferiority [ Time Frame: 4/15/2010-9/15/2011 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096953
|Contact: Eric D Colling, BSNemail@example.com|
|United States, Oregon|
|Douglas County Health & Social Services||Not yet recruiting|
|Roseburg, Oregon, United States, 97470|
|Contact: Janet Holland, LCSW 541-440-3526 firstname.lastname@example.org|
|Contact: Kimberly Mincher 5414403652 email@example.com|
|Sub-Investigator: Janet Holland, LCSW|
|Principal Investigator:||Nancy C Winters, MD||Oregon Health and Science University|