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CompletedNCT00543257Updated Oct 6, 2017

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

An observational study in Health Literacy, Attention Deficit Disorder With Hyperactivity and Computer Literacy, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-06.

Sponsored by Boston Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
194
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Health Literacy
  • Attention Deficit Disorder With Hyperactivity
  • Computer Literacy
  • Information Management
  • Parents
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In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 194 is above the median of 127 across 267 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
194 participants (actual)

Groups and cohorts

  • Parents

    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 · Other: Computer

Interventions

  • OtherUse of paper forms to write down information

    Parents will be asked to write down information specific to their child's ADHD using paper forms.

  • OtherComputer

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

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Study locations

1 site
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
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References and documents

Publications

  • Porter SC, Guo CY, Bacic J, Chan E. Health literacy and task environment influence parents' burden for data entry on child-specific health information: randomized controlled trial. J Med Internet Res. 2011 Jan 26;13(1):e13. doi: 10.2196/jmir.1612. PubMed 21269990 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00543257
Lead sponsor
Boston Children's Hospital
Collaborators
National Library of Medicine (NLM)
Responsible party
Eugenia Chan (Assistant In Medicine, Boston Children's Hospital) — Principal investigator
First posted
Oct 12, 2007
Start date
Dec 2007
Primary completion
Mar 2009
Completion
Jun 2014
Last update
Oct 6, 2017

Study contacts

Stephen Porter, MD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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