Skip to main content
OpenTrials
Completed

NCT Number: NCT02105142

Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health Center- Forest Manor, Indianapolis, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADHD Group Visits

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

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.

Computer Decision Support

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

Primary outcomes

  1. Change in Vanderbilt ADHD Rating Scale scores

    Time frame: Baseline & 12 months

    ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.

Secondary outcomes

  1. Change in scores for pediatric quality of life

    Time frame: Baseline & 12 months

    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.

  2. Change in score of multidimensional scale of perceived social support scale

    Time frame: Baseline & 12 months

    Social Support: 12-items perceptions on support

  3. Parental Locus of Control-Short Form

    Time frame: Baseline

    Locus of Control: 25-items, degree parent feels in control of child behavior

  4. Change in scores related to adaptive functioning

    Time frame: Baseline & 12 months

    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.

  5. Change in scores on Childhood ADHD & Family Impact Scale

    Time frame: Baseline & 12 months

    Study-specific tool, 9 items related to common challenges related to parenting based on feedback by patient advisory board

Other outcomes

  1. Demographics

    Time frame: Baseline

    Study-specific tool,12 items capturing demographics & characteristics of participant

  2. Satisfaction with content of group visits

    Time frame: Every 3 months at the end of each attended group visit

    Separate forms for parent and child feedback on group visits (5-6 items, 1 page); subjects in GV or GV-DP only

  3. Pediatric facilitator feedback form

    Time frame: Every 3 months at the end of each attended group visit

    Parent ratings of communication, teaching style and preparedness of pediatric facilitator; subjects in GV or GV-DP only

  4. Discussion portal feedback form

    Time frame: 12 months

    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

  5. Adherence to ADHD Group Visit curriculum

    Time frame: Every month for 15 months

    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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2014
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.