Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

NCT ID: NCT02105142

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

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).

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Computer Decision Support

ADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management

Group Type: ACTIVE_COMPARATOR

Computer Decision Support

Intervention Type: BEHAVIORAL

ADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management

ADHD Group visits

Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians

Group Type: ACTIVE_COMPARATOR

ADHD Group Visits

Intervention Type: BEHAVIORAL

Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians

ADHD Group Visits plus Online Discussion Portal

Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Online discussion portal access granted to parent participants and will allow parents to communicate with each other in between in-person group visits

Group Type: ACTIVE_COMPARATOR

ADHD Group Visits plus Online Discussion Portal

Intervention Type: BEHAVIORAL

Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Parent participants will be granted access to the online discussion portal to allow for communication in between in-person group visits.

Interventions

ADHD Group Visits

Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians

Intervention Type: BEHAVIORAL

ADHD Group Visits plus Online Discussion Portal

Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Parent participants will be granted access to the online discussion portal to allow for communication in between in-person group visits.

Intervention Type: BEHAVIORAL

Computer Decision Support

ADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Nerissa Bauer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nerissa S Bauer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Eskenazi Health Center-Blackburn

Indianapolis, Indiana, United States

Eskenazi Health Center- Forest Manor

Indianapolis, Indiana, United States

Eskenazi Health Center-W. 38th Street

Indianapolis, Indiana, United States

Eskenazi Health Center- Pecar

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23958768 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29877990 (View on PubMed)

Other Identifiers

1305011436

Identifier Type: -

Identifier Source: org_study_id