Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study (CATTS)

February 7, 2014 updated by: Kathleen Myers, Seattle Children's Hospital

Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
223

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • is 5.5 - 12 years of age
  • resides at home with parents/relatives
  • has a dx of ADHD (CBCL DSM-oriented elevation or previous diagnosis of ADHD; C-DISC diagnosis)
  • attends school 80% of time or more (including home-schooled children)
  • speaks English or Spanish and parent speaks English or Spanish

Exclusion Criteria:

  • child has a diagnosis of: CD, OCD, psychosis, BPD, Autism, mental retardation, major medical illness
  • resident parent has a drug use problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CATMH intervention
Child telemental health service delivery intervention
Other: CATMH intervention
This intervention is comprised of 6-tandem-sessions of pharmacotherapy and a behavioral intervention conducted over 4-5 months. The telepsychiatrist makes prescribing decisions during the intervention following consensus guidelines for ADHD treatment. The telepsychiatrist also provides education about how neurobiological deficits of ADHD relate to observed behavioral learning and difficulties. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by therapists at each participating clinic. The therapists are trained and supervised remotely by a telepsychologist . The 6-session behavioral intervention consists of approaches to managing children's behaviors and coordination with schools and other community agencies to advocate for the child.
Other Names:
  • Childrens' Telemental Health Service
No Intervention: augmented TAU/PCP
Augmented treatment as usual with primary care physician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assess whether using a telemental health service delivery model effects improvement in children diagnosed with ADHD including decreased symptoms of inattention, hyperactivity, opposition and defiance and improved adaptive functioning.
Time Frame: baseline, 4-, 10-, 19-, and 25-weeks
baseline, 4-, 10-, 19-, and 25-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assess whether using a telemental health service delivery model improves the well-being of caregivers of children diagnosed with ADHD.
Time Frame: baseline, 4-, 10-, 19- and 25-weeks
baseline, 4-, 10-, 19- and 25-weeks
Assess the ability of a telemental health service delivery model to improve treatment adherence in families of children with ADHD.
Time Frame: baseline, 4-, 10-, 19- and 25-weeks
baseline, 4-, 10-, 19- and 25-weeks
Assess how reliably an evidence-based treatment protocol for the treatment of children with ADHD can be implemented within a brief telemental health service.
Time Frame: baseline, 4-, 10-, 19-, and 25-weeks
baseline, 4-, 10-, 19-, and 25-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12537
  • R01MH081997 NIMH
  • R01MH081997 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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