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Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02105142
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Nerissa Bauer, Indiana University

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).


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: ADHD Group Visits Behavioral: ADHD Group Visits plus Online Discussion Portal Behavioral: Computer Decision Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
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

Active Comparator: ADHD Group visits
Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians
Behavioral: ADHD Group Visits
Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians

Active Comparator: 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
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105142


Locations
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United States, Indiana
General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
Eskenazi Health Center-Blackburn
Indianapolis, Indiana, United States, 46208
Eskenazi Health Center- Forest Manor
Indianapolis, Indiana, United States, 46226
Eskenazi Health Center-W. 38th Street
Indianapolis, Indiana, United States, 46254
Eskenazi Health Center- Pecar
Indianapolis, Indiana, United States, 46268
Sponsors and Collaborators
Indiana University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Nerissa S Bauer, MD, MPH Indiana University School of Medicine

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nerissa Bauer, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT02105142    
Other Study ID Numbers: 1305011436
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015
Keywords provided by Nerissa Bauer, Indiana University:
Attention deficit hyperactivity disorder
Interventions
Primary care
Pediatric
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms