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

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. Identifier: NCT00830700
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : February 11, 2014
University of Washington
Information provided by (Responsible Party):
Kathleen Myers, Seattle Children's Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Other: CATMH intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas
Study Start Date : September 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: Childrens' Telemental Health Service

No Intervention: augmented TAU/PCP
Augmented treatment as usual with primary care physician

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00830700

United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
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 automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Kathleen Myers, Principal Investigator, Seattle Children's Hospital Identifier: NCT00830700     History of Changes
Other Study ID Numbers: 12537
R01MH081997 NIMH
R01MH081997 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Kathleen Myers, Seattle Children's Hospital:
telemental health
rural mental health services for children

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms