Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
Response Variability in Children With ADHD
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 5, 2015
March 1, 2015
3 years
February 28, 2008
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days covered with medication as determined by pharmacy refill records
one year
Secondary Outcomes (4)
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
Study Arms (2)
Choice
EXPERIMENTALRecommendation
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- Diagnosed with ADHD based on DSM-IV criteria
- Enrolled in school-setting
- No learning disability
- No past use of psychoactive medication
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Brinkman, MD, MEd
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
September 1, 2007
Primary Completion
September 1, 2010
Study Completion
September 1, 2011
Last Updated
March 5, 2015
Record last verified: 2015-03