NCT00631280CompletedNot Applicable
Response Variability in Children With ADHD
Children's Hospital Medical Center, Cincinnati1 site in 1 country70 target enrollmentStarted: September 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Number of days covered with medication as determined by pharmacy refill records
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Choice
Experimental
Intervention: Choice (Behavioral)
Recommendation
Active Comparator
Intervention: Recommendation (Behavioral)
Outcomes
Primary Outcomes
Number of days covered with medication as determined by pharmacy refill records
Time Frame: one year
Secondary Outcomes
- Decisional Conflict(immediately after intervention or control condition delivered)
- Decisional Regret(immediately after intervention or control condition delivered)
- Satisfaction with Information about Medicine(immediately after intervention or control condition delivered)
- Working Alliance Inventory(immediately after intervention or control condition delivered)
Investigators
Bill Brinkman
Associate Professor
Children's Hospital Medical Center, Cincinnati
Study Sites (1)
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