Contemporary Clinical Trials Communications | 2019
Testing the efficacy of the Nurtured Heart Approach® to reduce ADHD symptoms in children by training parents: Protocol for a randomized controlled trial
Abstract
Attention Deficit Hyperactivity Disorder (ADHD), as currently defined in the Diagnostic and Statistical Manual-5 (DSM-5), is a disorder with a childhood onset, which interferes with normal school and social activities [1]. ADHD has two primary presentations, inattentive type and hyperactive-impulsive type, although a combined type is also recognized. Parents find their child with ADHD extremely challenging to manage using traditional parenting approaches. Most children with ADHD have a difficult time focusing (inattention), act without thinking (impulsive), and/or cannot sit still (hyperactive). At present, ADHD is a pervasive and costly neurodevelopmental condition [2,3]. According to U.S. parental reports, 6.1 million children, between the ages of two and 17 years, have a diagnosis of ADHD [4]. This is approximately the same as the population of the entire state of Arizona (6.9 million) [5]. Moreover, in 2010, U.S. costs related to ADHD were between $143 and $226 billion for adults and children diagnosed with ADHD and their families [3]. These costs are attributable to employment losses, healthcare issues, educational problems, and legal involvement. As of 2011, to treat ADHD, the American Academy of Pediatrics (AAP) recommends medication approved by the Food and Drug Administration and/or evidence-based parent/teacher behavioral treatment for children ages six to 11 years [6]. The earlier 2007 guidelines published by the American Academy of Child and Adolescent Psychiatry noted that a comprehensive treatment plan which considered both behavioral and parenting interventions was important, although they concluded that available evidence supported pharmacologic treatment as the most effective modality. They did note that parents preferences were important to developing a final treatment protocol [7]. Many parents have significant concerns about the use of stimulants in children and prefer exploring non-pharmacologic approaches. A recent meta-analysis surveying pharmacologic, psychosocial, and alternative medicine modalities documented the wide range of ADHD treatment options available to parents, with a lack of any definitive evidence-based treatment recommendation [8]. One non-pharmacologic option is the Nurtured Heart Approach (NHA), a behavioral intervention that aims to improve parent responses to intense (problematic) child behaviors, such as those exhibited by children with ADHD [9]. The purpose of this paper is to document the protocol of the NHA study. To that end, this paper describes the recruitment, screening, and enrollment process; an overview of the intervention; and procedures for the collection and analysis of data.