Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study (CATTS)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CATMH intervention
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, telemental health, TMH, telepsychiatry, rural mental health services for children
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
Sites / Locations
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CATMH intervention
augmented TAU/PCP
Arm Description
Child telemental health service delivery intervention
Augmented treatment as usual with primary care physician
Outcomes
Primary Outcome 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.
Secondary Outcome Measures
Assess whether using a telemental health service delivery model improves the well-being of caregivers of children diagnosed with ADHD.
Assess the ability of a telemental health service delivery model to improve treatment adherence in families of children with ADHD.
Assess how reliably an evidence-based treatment protocol for the treatment of children with ADHD can be implemented within a brief telemental health service.
Full Information
NCT ID
NCT00830700
First Posted
January 27, 2009
Last Updated
February 7, 2014
Sponsor
Seattle Children's Hospital
Collaborators
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT00830700
Brief Title
Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study
Acronym
CATTS
Official Title
Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, telemental health, TMH, telepsychiatry, rural mental health services for children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CATMH intervention
Arm Type
Experimental
Arm Description
Child telemental health service delivery intervention
Arm Title
augmented TAU/PCP
Arm Type
No Intervention
Arm Description
Augmented treatment as usual with primary care physician
Intervention Type
Other
Intervention Name(s)
CATMH intervention
Other Intervention Name(s)
Childrens' Telemental Health Service
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Myers, MD, MPH, MS
Organizational Affiliation
Children's Hospital and Regional Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Vander Stoep, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth McCauley, PhD
Organizational Affiliation
University of Washington; Children's Hospital and Regional Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wayne Katon, MD
Organizational Affiliation
University of Washington
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carolyn McCarty, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32167784
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.
Results Reference
derived
PubMed Identifier
27117555
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.
Results Reference
derived
PubMed Identifier
26258927
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.
Results Reference
derived
PubMed Identifier
25791143
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.
Results Reference
derived
PubMed Identifier
23952184
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.
Results Reference
derived
PubMed Identifier
23952183
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.
Results Reference
derived
PubMed Identifier
23897950
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.
Results Reference
derived
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Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study
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