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Completed

NCT Number: NCT00830700

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CATMH intervention

Other

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 names: Childrens' Telemental Health Service

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • University of Washington

Registry information

Official study title

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

Acronym: CATTS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2009
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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