Telepsychiatry in Rural Youth

NCT01096953 | Withdrawn DMC

• 1 other identifier: 1R21MH079984-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.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).
2. 2.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.
3. 3.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.
4. 4.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.
5. 5.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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; attention deficit

Outcome Measures

Primary Outcomes (1)

• Equivalence

  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.

  4/15/2010-9/15/2011

Secondary Outcomes (1)

• Non-inferiority

  4/15/2010-9/15/2011

Study Arms (2)

Telepsychiatry

ACTIVE COMPARATOR

Psychiatry provided over telehealth network

Behavioral: Mental health care implemented by telepsychiatry; Behavioral: Face-to-face care

Face-to-face care

ACTIVE COMPARATOR

Psychiatry provided in person

Behavioral: Face-to-face care

Interventions

Mental health care implemented by telepsychiatry BEHAVIORAL

Care of 6-17 year-olds with ADHD

Telepsychiatry

Face-to-face care BEHAVIORAL

Psychiatry provided for treatment of ADHD face-to-face in office

Face-to-face care; Telepsychiatry

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Learning disorders, such as Mathematics Disorder, Reading Disorder, and Disorders of Written Expression.
• Other disruptive disorders, such as (oppositional Oppositional defiant Defiant disorder Disorder and conduct Conduct disorder.)
• Unipolar mood disorders, including Major Depressive Disorder and Dysthymic Disorder
• Anxiety disorders hat coexist with ADHD, anxiety, and
• Post traumatic stress disorder (PTSD).
• Non-rapid cycling bipolar disorder stable on medications
• 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:

You may not qualify if:

• Rapid cycling bipolar disorder
• A history of psychosis of any etiology. (Exceptions may include temporary medically or pharmacologically induced delirium.)
• Medically impairing eating disorders,
• Substance abuse within the past year or "active substance use"
• Mental retardation (IQ \< 70)
• Autism spectrum disorders.
• Children and families who are not English speaking will not be included in the study.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Douglas County Health & Social Services

Roseburg, Oregon, 97470, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nancy C Winters, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

US (1)