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

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: CATMH intervention
  • Child and adolescent telemental health service delivery intervention
• No Intervention: augmented TAU/PCP
  • Augmented treatment as usual with primary care physician

Primary 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
    Safety Issue?: No

Secondary 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
    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
    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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Seattle Children's Hospital Other

Overall Clinical Trial Officials and Contacts

Kathleen Myers, MD, MPH, MS Principal Investigator Children's Hospital and Regional Medical Center  

Overall Contact: Kathleen Myers, MD, MPH, MS 206-987-1663 kathleen.myers@seattlechildrens.org

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00830700

Study ID Number: 12537

ClinicalTrials.gov Identifier: NCT00830700

Health Authority: United States: Institutional Review Board