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Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00631280
First received: February 28, 2008
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

The purpose of the study is to determine whether active parent involvement in deliberation and choice improves subsequent medication persistence for their child with ADHD.


Condition Intervention
Attention-Deficit/Hyperactivity Disorder (ADHD)
 Behavioral: Choice
Behavioral: Recommendation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Response Variability in Children With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Number of days covered with medication as determined by pharmacy refill records [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decisional Conflict [ Time Frame: immediately after intervention or control condition delivered ] [ Designated as safety issue: No ]
  • Decisional Regret [ Time Frame: immediately after intervention or control condition delivered ] [ Designated as safety issue: No ]
  • Satisfaction with Information about Medicine [ Time Frame: immediately after intervention or control condition delivered ] [ Designated as safety issue: No ]
  • Working Alliance Inventory [ Time Frame: immediately after intervention or control condition delivered ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Choice Behavioral: Choice
Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a decision aid. Parent treatment preferences will be elicited and parents will receive coaching in deliberation about striking a balance between benefit and tolerable side effects. Parent will then choose the week that was best for their child and plan their next steps. Parents will also receive a consultation report that contains a physician dosage recommendation.
Active Comparator: Recommendation Behavioral: Recommendation
Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a consultation report that also contains a physician dosage recommendation.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with ADHD based on DSM-IV criteria
  • Enrolled in school-setting
  • No learning disability
  • No past use of psychoactive medication

Exclusion Criteria:

  • Do not meet DSM-IV criteria for ADHD
  • Not enrolled in school-setting
  • Presence of learning disability
  • History of brain injury
  • Past use of psychoactive medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631280

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: William Brinkman, MD, MEd Cincinnati Children's Medical Center
  More Information

No publications provided

Responsible Party: William B. Brinkman/Principal Investigator, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00631280     History of Changes
Other Study ID Numbers: 05-12-16, 5R01MH074770-02
Study First Received: February 28, 2008
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Decision Aid
Informed Choice
Adherence

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

ClinicalTrials.gov processed this record on May 23, 2013