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

NCT00830700 | Completed DMC

• 3 other identifiers: 12537R01MH081997 NIMHR01MH081997
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; telemental health; TMH; telepsychiatry; rural mental health services for children

Outcome Measures

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.

  baseline, 4-, 10-, 19-, and 25-weeks

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

CATMH intervention

EXPERIMENTAL

Child telemental health service delivery intervention

Other: CATMH intervention

augmented TAU/PCP

NO INTERVENTION

Augmented treatment as usual with primary care physician

Interventions

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.

Also known as: Childrens' Telemental Health Service

CATMH intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• child has a diagnosis of: CD, OCD, psychosis, BPD, Autism, mental retardation, major medical illness
• resident parent has a drug use problem

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (7)

• Rockhill CM, Carlisle LL, Qu P, Vander Stoep A, French W, Zhou C, Myers K. Primary Care Management of Children with Attention-Deficit/Hyperactivity Disorder Appears More Assertive Following Brief Psychiatric Intervention Compared with Single Session Consultation. J Child Adolesc Psychopharmacol. 2020 Jun;30(5):285-292. doi: 10.1089/cap.2020.0013. Epub 2020 Mar 11.

  PMID: 32167784 DERIVED

• Vander Stoep A, McCarty CA, Zhou C, Rockhill CM, Schoenfelder EN, Myers K. The Children's Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes. J Abnorm Child Psychol. 2017 Jan;45(1):27-43. doi: 10.1007/s10802-016-0155-7.

  PMID: 27117555 DERIVED

• Rockhill CM, Tse YJ, Fesinmeyer MD, Garcia J, Myers K. Telepsychiatrists' Medication Treatment Strategies in the Children's Attention-Deficit/Hyperactivity Disorder Telemental Health Treatment Study. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):662-671. doi: 10.1089/cap.2015.0017. Epub 2015 Aug 10.

  PMID: 26258927 DERIVED

• Myers K, Vander Stoep A, Zhou C, McCarty CA, Katon W. Effectiveness of a telehealth service delivery model for treating attention-deficit/hyperactivity disorder: a community-based randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2015 Apr;54(4):263-74. doi: 10.1016/j.jaac.2015.01.009. Epub 2015 Jan 29.

  PMID: 25791143 DERIVED

• Rockhill C, Violette H, Vander Stoep A, Grover S, Myers K. Caregivers' distress: youth with attention-deficit/hyperactivity disorder and comorbid disorders assessed via telemental health. J Child Adolesc Psychopharmacol. 2013 Aug;23(6):379-85. doi: 10.1089/cap.2013.0019.

  PMID: 23952184 DERIVED

• Myers K, Vander Stoep A, Lobdell C. Feasibility of conducting a randomized controlled trial of telemental health with children diagnosed with attention-deficit/hyperactivity disorder in underserved communities. J Child Adolesc Psychopharmacol. 2013 Aug;23(6):372-8. doi: 10.1089/cap.2013.0020.

  PMID: 23952183 DERIVED

• Vander Stoep A, Myers K. Methodology for conducting the children's attention-deficit hyperactivity disorder telemental health treatment study in multiple underserved communities. Clin Trials. 2013;10(6):949-58. doi: 10.1177/1740774513494880. Epub 2013 Jul 29.

  PMID: 23897950 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kathleen Myers, MD, MPH, MS

  Children's Hospital and Regional Medical Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

US (1)