Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105142
• Other study ID #: 1305011436
• Status: Completed
• Phase: N/A
• First received: March 30, 2014
• Last updated: November 6, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• ADHD Group Visits
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. Parent participants will be granted access to the online discussion portal to allow for communication in between in-person group visits.
• 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

Locations

Country	Name	City	State
United States	Eskenazi Health Center- Forest Manor	Indianapolis	Indiana
United States	Eskenazi Health Center- Pecar	Indianapolis	Indiana
United States	Eskenazi Health Center-Blackburn	Indianapolis	Indiana
United States	Eskenazi Health Center-W. 38th Street	Indianapolis	Indiana
United States	General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Study-specific tool,12 items capturing demographics & characteristics of participant	Baseline	No
Other	Satisfaction with content of group visits	Separate forms for parent and child feedback on group visits (5-6 items, 1 page); subjects in GV or GV-DP only	Every 3 months at the end of each attended group visit	No
Other	Pediatric facilitator feedback form	Parent ratings of communication, teaching style and preparedness of pediatric facilitator; subjects in GV or GV-DP only	Every 3 months at the end of each attended group visit	No
Other	Discussion portal feedback form	Closed and open ended questions about: if parent accessed the online discussion portal (yes/no), how often accessed (daily/weekly/monthly/never), perceived benefits of the online discussion portal, any suggestions for usefulness; subjects in GV-DP only	12 months	No
Other	Adherence to ADHD Group Visit curriculum	Protocol checklist for each session to be completed by facilitators after each session and by study team to monitor adherence; facilitators and study team only	Every month for 15 months	No
Primary	Change in Vanderbilt ADHD Rating Scale scores	ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.	Baseline & 12 months	No
Secondary	Change in scores for pediatric quality of life	Quality of Life (generic core scales): 23 items, related to quality of life and child's needs in context of the family. Parent and child report.	Baseline & 12 months	No
Secondary	Change in score of multidimensional scale of perceived social support scale	Social Support: 12-items perceptions on support	Baseline & 12 months	No
Secondary	Parental Locus of Control-Short Form	Locus of Control: 25-items, degree parent feels in control of child behavior	Baseline	No
Secondary	Change in scores related to adaptive functioning	13 items, parent-report, measuring adaptive functioning in the home using the Home Situations Questionnaire. Responses at each separate time point will be compared to the study specific Childhood ADHD and Family Impact Scale scores for correlation.	Baseline & 12 months	No
Secondary	Change in scores on Childhood ADHD & Family Impact Scale	Study-specific tool, 9 items related to common challenges related to parenting based on feedback by patient advisory board	Baseline & 12 months	No