Clinical trial NCT00830700: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
telemental health
TMH
telepsychiatry
rural mental health services for children
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2009-01-28
Enrollment: 223
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: baseline, 4-, 10-, 19-, and 25-weeks
Secondary outcomes:
measure: Assess whether using a telemental health service delivery model improves the well-being of caregivers of children diagnosed with ADHD.
timeFrame: baseline, 4-, 10-, 19- and 25-weeks
measure: Assess the ability of a telemental health service delivery model to improve treatment adherence in families of children with ADHD.
timeFrame: baseline, 4-, 10-, 19- and 25-weeks
measure: Assess how reliably an evidence-based treatment protocol for the treatment of children with ADHD can be implemented within a brief telemental health service.
timeFrame: baseline, 4-, 10-, 19-, and 25-weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital and Regional Medical Center
name: Kathleen Myers, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Ann Vander Stoep, PhD
role: STUDY_DIRECTOR
affiliation: University of Washington; Children's Hospital and Regional Medical Center
name: Elizabeth McCauley, PhD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Wayne Katon, MD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Carolyn McCarty, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.