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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00543257
First received: October 10, 2007
Last updated: March 26, 2009
Last verified: March 2009
  Purpose

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 Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Parents at the Center: Information Management in ADHD - Clinical Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Estimated Enrollment: 224
Study Start Date: December 2007
Estimated Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Parents of school-age children with ADHD

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543257

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Stephen Porter, MD Children's Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen C Porter/ Assistant Professor, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00543257     History of Changes
Other Study ID Numbers: CHB-R01LM009256
Study First Received: October 10, 2007
Last Updated: March 26, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014