Text Size

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

This study is currently recruiting participants.
Verified April 2012 by Seattle Children's Hospital
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Kathleen Myers, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00830700
First received: January 27, 2009
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Attention Deficit Disorder With Hyperactivity
 Other: CATMH intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830700

Contacts
Contact: Kathleen M Myers, MD, MPH, MS 206-987-1663 kathleen.myers@seattlechildrens.org
Contact: Heather D Violette, PhD 206-884-8259 heather.violette@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Kathleen M Myers, MD, MPH, MS     206-987-1663     kathleen.myers@seattlechildrens.org    
Contact: Heather D Violette, PhD     206-884-8259     heather.violette@seattlechildrens.org    
Principal Investigator: Kathleen Myers, MD, MPH, MS            
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
Investigators
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
  More Information

No publications provided

Responsible Party: Kathleen Myers, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00830700     History of Changes
Other Study ID Numbers: 12537, R01MH081997 NIMH
Study First Received: January 27, 2009
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
ADHD
telemental health
TMH
telepsychiatry
rural mental health services for children

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 18, 2012