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Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADHD Group Visits
ADHD Group Visits plus Online Discussion Portal
Computer Decision Support
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention deficit hyperactivity disorder, Interventions, Primary care, Pediatric

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
  • Eskenazi Health Center-Blackburn
  • Eskenazi Health Center- Forest Manor
  • Eskenazi Health Center-W. 38th Street
  • Eskenazi Health Center- Pecar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Computer Decision Support

ADHD Group visits

ADHD Group Visits plus Online Discussion Portal

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Vanderbilt ADHD Rating Scale scores
ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.

Secondary Outcome Measures

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.
Change in score of multidimensional scale of perceived social support scale
Social Support: 12-items perceptions on support
Parental Locus of Control-Short Form
Locus of Control: 25-items, degree parent feels in control of child behavior
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.
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

Full Information

First Posted
March 30, 2014
Last Updated
November 6, 2015
Sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT02105142
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention deficit hyperactivity disorder, Interventions, Primary care, Pediatric

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer Decision Support
Arm Type
Active Comparator
Arm Description
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
Arm Title
ADHD Group visits
Arm Type
Active Comparator
Arm Description
Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians
Arm Title
ADHD Group Visits plus Online Discussion Portal
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
ADHD Group Visits
Intervention Description
Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians
Intervention Type
Behavioral
Intervention Name(s)
ADHD Group Visits plus Online Discussion Portal
Intervention Description
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
Intervention Name(s)
Computer Decision Support
Intervention Description
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 Outcome Measure Information:
Title
Change in Vanderbilt ADHD Rating Scale scores
Description
ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.
Time Frame
Baseline & 12 months
Secondary Outcome Measure Information:
Title
Change in scores for pediatric quality of life
Description
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.
Time Frame
Baseline & 12 months
Title
Change in score of multidimensional scale of perceived social support scale
Description
Social Support: 12-items perceptions on support
Time Frame
Baseline & 12 months
Title
Parental Locus of Control-Short Form
Description
Locus of Control: 25-items, degree parent feels in control of child behavior
Time Frame
Baseline
Title
Change in scores related to adaptive functioning
Description
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.
Time Frame
Baseline & 12 months
Title
Change in scores on Childhood ADHD & Family Impact Scale
Description
Study-specific tool, 9 items related to common challenges related to parenting based on feedback by patient advisory board
Time Frame
Baseline & 12 months
Other Pre-specified Outcome Measures:
Title
Demographics
Description
Study-specific tool,12 items capturing demographics & characteristics of participant
Time Frame
Baseline
Title
Satisfaction with content of group visits
Description
Separate forms for parent and child feedback on group visits (5-6 items, 1 page); subjects in GV or GV-DP only
Time Frame
Every 3 months at the end of each attended group visit
Title
Pediatric facilitator feedback form
Description
Parent ratings of communication, teaching style and preparedness of pediatric facilitator; subjects in GV or GV-DP only
Time Frame
Every 3 months at the end of each attended group visit
Title
Discussion portal feedback form
Description
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
Time Frame
12 months
Title
Adherence to ADHD Group Visit curriculum
Description
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
Time Frame
Every month for 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nerissa S Bauer, MD, MPH
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Eskenazi Health Center-Blackburn
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
Eskenazi Health Center- Forest Manor
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46226
Country
United States
Facility Name
Eskenazi Health Center-W. 38th Street
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Eskenazi Health Center- Pecar
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23958768
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.
Results Reference
background
PubMed Identifier
29877990
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.
Results Reference
derived

Learn more about this trial

Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

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