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

Attention Deficit Disorder With Hyperactivity Clinical Trial

— CATTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830700
• Other study ID #: 12537
• Secondary ID: R01MH081997 NIMH
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: February 7, 2014
• Start date: September 2009
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline, 4-, 10-, 19-, and 25-weeks	No
Secondary	Assess whether using a telemental health service delivery model improves the well-being of caregivers of children diagnosed with ADHD.		baseline, 4-, 10-, 19- and 25-weeks	No
Secondary	Assess the ability of a telemental health service delivery model to improve treatment adherence in families of children with ADHD.		baseline, 4-, 10-, 19- and 25-weeks	No
Secondary	Assess how reliably an evidence-based treatment protocol for the treatment of children with ADHD can be implemented within a brief telemental health service.		baseline, 4-, 10-, 19-, and 25-weeks	No