Clinical trial NCT02105142: Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD
Official title: Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention deficit hyperactivity disorder
Interventions
Primary care
Pediatric
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-04-07
Enrollment: 81
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, affecting approximately 8% of youth. Children with ADHD often have problems sustaining attention and completing multi-step commands and tasks of daily living, such as homework. Pediatricians are often the first physicians to identify problems with children's functioning at home and at school. However, because of limited visit time, pediatricians often struggle with managing ADHD while trying to also cover a vast array of other primary care issues. Moreover, as there is a nationwide shortage of pediatric mental health specialists and access to parenting programs is limited, a critical need exists to develop interventions that form partnerships between behavioral and mental health specialists and the primary care pediatrician. One approach is to base interventions in the pediatric clinic to ensure children have access to appropriate treatment. Thus far, only a limited number of sites have this pediatric-mental health partnership.

Health information technology (HIT) has been used to enhance primary care management of ADHD. HIT can improve pediatricians' ability not only to adhere to recommended guidelines, but also to screen for co-existing disorders and provide timely parental education. An alternative strategy might be to use group visits (GV). GV afford more time with families and allows the pediatrician to facilitate more in-depth discussions. More importantly, the group model allows parents to learn from one another, normalizes parenting expectations, and addresses shared experiences of medication side effects and other factors related to adherence. Moreover, a group visit can be conducted in a physical location, such as the pediatric clinic, or be brought into the virtual world with the aid of social media. Virtual support groups for chronic care diseases have become an increasingly popular way for a community of individuals to exchange information and offer emotional support.

Prior to the adoption of these interventions into primary care practice, investigators must know which is best. Rigorous comparative effectiveness research (CER) can help to determine this. This proposal will compare a HIT based intervention to a GV strategy, with and without the use of social media. These 3 interventions will be compared based not only on clinical measures of interest but also on parent-defined patient outcomes. Prior research has largely focused on measuring clinical outcomes such as treatment adherence and ADHD symptom reduction with little emphasis on understanding how patient-centered outcomes, such as the quality of life of families dealing with ADHD, are affected.

Building on previous work, the specific aims for this study are:

Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning Aim 1b) Compare the effectiveness of the three interventions on patient-centered outcomes such as quality of life and parental satisfaction with the intervention The three interventions will be: 1) Child Health Improvement through Computer Automation (CHICA) which is the health information technology innovation arm; 2) Group visits (GV); or 3) Group visits plus online discussion portal (GV+DP).


Eligibility criteria: Inclusion Criteria:

* Children 6 to 12 years of age with diagnosis of ADHD and their parents
* Children must receive medical care at participating study clinics
* Children must have diagnosis of ADHD based on parent and teacher diagnostic and statistical manual-IV rating scales
* Children can have co-existing Oppositional Defiant Disorder (ODD)

Exclusion Criteria:

* Children with co-existing diagnosis of Conduct Disorder (CD)
* Children with autism
* Children with moderate to severe mental handicap or other neurodevelopment disorder that would preclude active participation in group discussions

Primary outcomes:
measure: Change in Vanderbilt ADHD Rating Scale scores
timeFrame: Baseline & 12 months
Secondary outcomes:
measure: Change in scores for pediatric quality of life
timeFrame: Baseline & 12 months
measure: Change in score of multidimensional scale of perceived social support scale
timeFrame: Baseline & 12 months
measure: Parental Locus of Control-Short Form
timeFrame: Baseline
measure: Change in scores related to adaptive functioning
timeFrame: Baseline & 12 months
measure: Change in scores on Childhood ADHD & Family Impact Scale
timeFrame: Baseline & 12 months
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Satisfaction with content of group visits
timeFrame: Every 3 months at the end of each attended group visit
measure: Pediatric facilitator feedback form
timeFrame: Every 3 months at the end of each attended group visit
measure: Discussion portal feedback form
timeFrame: 12 months
measure: Adherence to ADHD Group Visit curriculum
timeFrame: Every month for 15 months
Locations:
city: Indianapolis
country: United States
facility: General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Center-Blackburn
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Center- Forest Manor
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Center-W. 38th Street
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Health Center- Pecar
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Nerissa S Bauer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19.
citation: Bauer NS, Sullivan PD, Szczepaniak D, Stelzner SM, Pottenger A, Ofner S, Downs SM, Carroll AE. Attention Deficit-Hyperactivity Disorder Group Visits Improve Parental Emotional Health and Perceptions of Child Behavior. J Dev Behav Pediatr. 2018 Jul/Aug;39(6):461-470. doi: 10.1097/DBP.0000000000000575.