Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study - Full Text View

Sponsored by:	Seattle Children's Hospital
Information provided by:	Seattle Children's Hospital
ClinicalTrials.gov Identifier:	NCT00830700

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

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Child Mental Health Choosing a Doctor or Health Care Service Mental Health

U.S. FDA Resources

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

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:	April 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CATMH intervention: Experimental Child and adolescent 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 and the local primary care physician (PCP) make prescribing decisions and the PCP prescribes the medication, following evidence-based practice. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by trained therapists at each participating clinic. The 6-session behavioral intervention consists of: 1) parent education about how neurobiological deficits of ADHD relate to observed behavioral difficulties; 2)approaches to manage children's behaviors and help them to become "self-managers"; and 3) coordination with schools and other community agencies to advocate for the child.
augmented TAU/PCP: No Intervention Augmented treatment as usual with primary care physician

Arms

Assigned Interventions

CATMH intervention: Experimental

Child and adolescent 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 and the local primary care physician (PCP) make prescribing decisions and the PCP prescribes the medication, following evidence-based practice. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by trained therapists at each participating clinic. The 6-session behavioral intervention consists of: 1) parent education about how neurobiological deficits of ADHD relate to observed behavioral difficulties; 2)approaches to manage children's behaviors and help them to become "self-managers"; and 3) coordination with schools and other community agencies to advocate for the child.

augmented TAU/PCP: No Intervention

Augmented treatment as usual with primary care physician

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

is 6-12 years of age
resides at home with parents/relatives
has a dx of ADHD (CBCL DSM-oriented elevation and C-DISC diagnosis)
has a parent-report CIS score of 18 or higher
attends school 80% of time or more
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 Myers, MD, MPH, MS	206-987-1663	kathleen.myers@seattlechildrens.org
Contact: Nancy Palmer, PhD	206-884-1844	nancy.palmer@seattlechildrens.org

Locations

United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Seattle Children's Hospital

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:	Children's Hospital and Regional Medical Center, Seattle ( Kathleen Myers, MD, MPH )
Study ID Numbers:	12537, R01MH081997 NIMH
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00830700 History of Changes
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

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on May 06, 2009