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

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.

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

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Other: CATMH intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CATMH intervention<br>Child telemental health service delivery intervention | Other: CATMH intervention<br>* 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.<br>* Other names: Childrens' Telemental Health Service;|
| No Intervention: augmented TAU/PCP<br>Augmented treatment as usual with primary care physician | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemental health, TMH, telepsychiatry, rural mental health services for children, ADHD