Telemental Health to Improve Mental Health Care and Outcomes for Children in Underserved Areas
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 223
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CATMH intervention
Child telemental health service delivery intervention
Intervention: CATMH intervention (Other)
augmented TAU/PCP
Augmented treatment as usual with primary care physician
Outcomes
Primary Outcomes
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
- 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)
Investigators
Kathleen Myers
Principal Investigator
Seattle Children's Hospital