Parents at the Center: Information Management in ADHD - Clinical Trial

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. Identifier: NCT00543257
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : October 6, 2017
National Library of Medicine (NLM)
Information provided by (Responsible Party):
Eugenia Chan, Boston Children’s Hospital

Brief Summary:
Health literacy is an integral part of the pathway for the successful transfer of information between patients and providers. Parents of children with Attention Deficit/ Hyperactivity Disorder (ADHD) play an essential role in chronic care as they offer critical information to providers that drives appropriate education and disease management. We propose the development and evaluation of an electronic data entry tool that enables parents to communicate data essential to treatment of their children, regardless of their own literacy skills. The research plan addresses a question central to patient-centered information management: how does health literacy influence parents' report of data on ADHD and the process-level events that result from parent-provider communication? The following specific aims organize the clinical study: proposal: 1) To assess the effect of health literacy on successful completion of parent-reported ADHD health information in both paper-based and PCHR formats, and, 2): To determine the association between health literacy and process-level outcomes for ADHD that stem from parent-provider exchange of information. The formal evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper versus PCHR) for ADHD-specific information. Primary care records for children of this cohort will be analyzed for the prior 12 month period. Both a retrospective examination of documented ADHD processes of care and a prospective evaluation of the utility of data from the PCHR will occur. Literacy level is a primary variable of interest throughout the evaluation.

Condition or disease Intervention/treatment
Health Literacy Attention Deficit Disorder With Hyperactivity Computer Literacy Information Management Parents Other: Use of paper forms to write down information Other: Computer

Study Type : Observational
Actual Enrollment : 194 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Parents at the Center: Information Management in ADHD - Clinical Trial
Actual Study Start Date : December 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2014

Group/Cohort Intervention/treatment
Parents of children with ADHD will be recruited from the greater Boston community. We are interested in enrollment of parents with a range of educational and technical backgrounds, and specifically will look to enroll parents who may not have much computer experience.
Other: Use of paper forms to write down information
Parents will be asked to write down information specific to their child's ADHD using paper forms.

Other: Computer
Parents will use a computer to complete data entry on information specific to their child's ADHD care

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parents of school-age children with ADHD

Inclusion Criteria:

  • Primary language of parent/guardian is English or Spanish
  • Parent/guardian reports that child has been diagnosed with ADHD
  • Current child age is between 5 years and 12 years
  • Child in question resides with the parental subject primarily
  • Parent/guardian reports that they are the primary caretaker of the child
  • Parent/guardian reports that they are the person who communicates with the primary care provider
  • Parent/guardian reports that child is currently taking medication for ADHD or has taken it within the last 3 months

Exclusion Criteria:

  • Parent reports that child in question has been diagnosed with mental retardation, autism, pervasive developmental disorder, Aspergers, or bipolar disorder

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 identifier (NCT number): NCT00543257

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
National Library of Medicine (NLM)
Principal Investigator: Stephen Porter, MD Boston Children’s Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eugenia Chan, Assistant In Medicine, Boston Children’s Hospital Identifier: NCT00543257     History of Changes
Other Study ID Numbers: CHB-R01LM009256
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders