This trial is active, not recruiting.

Conditions health literacy, attention deficit disorder with hyperactivity, computer literacy, information management, parents
Treatments use of paper forms to write down information, computer
Sponsor Children's Hospital Boston
Collaborator National Library of Medicine (NLM)
Start date December 2007
End date March 2009
Trial size 224 participants
Trial identifier NCT00543257, CHB-R01LM009256


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
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.
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.
Parents will use a computer to complete data entry on information specific to their child's ADHD care

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Parents at the Center: Information Management in ADHD - Clinical Trial
Principal investigator Stephen Porter, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.