Attention Deficit Hyperactivity DisorderNCT01096953
Telepsychiatry in Rural Youth
A study testing Mental health care implemented by telepsychiatry and Face-to-face care in people with Attention Deficit Hyperactivity Disorder, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Mental health care implemented by telepsychiatry and Face-to-face care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- 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
Show all 10Show fewer
- Post traumatic stress disorder (PTSD).
- Non-rapid cycling bipolar disorder stable on medications
- 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Douglas County Health & Social Services
Roseburg, Oregon, 97470
About this study
Official title: A Randomized Exploratory Study of Telepsychiatry Outcomes in Rural Youth
- 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Mental health care implemented by telepsychiatry, Face-to-face care
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, attention deficit
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental health care implemented by telepsychiatryBehavioural
Care of 6-17 year-olds with ADHD
Face-to-face careBehavioural
Psychiatry provided for treatment of ADHD face-to-face in office
| Study group | Role | What they receive |
|---|---|---|
| Telepsychiatry | Active comparator | Psychiatry provided over telehealth network Receives: Behavioral: Mental health care implemented by telepsychiatry; Behavioral: Face-to-face care |
| Face-to-face care | Active comparator | Psychiatry provided in person Receives: Behavioral: Face-to-face care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4/15/2010-9/15/2011
Secondary outcomes (1)
Non-inferiority
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.
Measured: 4/15/2010-9/15/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Not human subject research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy C Winters, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096953
- Sponsor's protocol ID
- 1R21MH079984-01
- Status last verified
- Sep 2019
- First submitted
- 30 Mar 2010
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Exploratory Study of Telepsychiatry Outcomes in Rural Youth
- ClinicalTrials.gov ID
- NCT01096953
- Acronym / sponsor ID
- 1R21MH079984-01
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, attention deficit
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not human subject research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telepsychiatry | Active comparator | Behavioral: Mental health care implemented by telepsychiatry, Behavioral: Face-to-face carePsychiatry provided over telehealth network |
| Face-to-face care | Active comparator | Behavioral: Face-to-face carePsychiatry provided in person |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental health care implemented by telepsychiatryCare of 6-17 year-olds with ADHD | Behavioural | Telepsychiatry |
| Face-to-face carePsychiatry provided for treatment of ADHD face-to-face in office | Behavioural | Face-to-face care, Telepsychiatry |
Primary outcome
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.
1 secondary outcome
Non-inferiority
Time frame: 4/15/2010-9/15/2011
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy C Winters, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental health care implemented by telepsychiatry and Face-to-face care in people with Attention Deficit Hyperactivity Disorder, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence (time frame: 4/15/2010-9/15/2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.