Back to resultsDoes Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
Primary Purpose
Attention-Deficit/Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choice
Recommendation
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder (ADHD) focused on measuring Decision Aid, Informed Choice, Adherence
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Choice
Recommendation
Arm Description
Outcomes
Primary Outcome Measures
Number of days covered with medication as determined by pharmacy refill records
Secondary Outcome Measures
Decisional Conflict
Decisional Regret
Satisfaction with Information about Medicine
Working Alliance Inventory
Full Information
NCT ID
NCT00631280
First Posted
February 28, 2008
Last Updated
March 3, 2015
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00631280
Brief Title
Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
Official Title
Response Variability in Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords
Decision Aid, Informed Choice, Adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choice
Arm Type
Experimental
Arm Title
Recommendation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Choice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recommendation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of days covered with medication as determined by pharmacy refill records
Time Frame
one year
Secondary Outcome Measure Information:
Title
Decisional Conflict
Time Frame
immediately after intervention or control condition delivered
Title
Decisional Regret
Time Frame
immediately after intervention or control condition delivered
Title
Satisfaction with Information about Medicine
Time Frame
immediately after intervention or control condition delivered
Title
Working Alliance Inventory
Time Frame
immediately after intervention or control condition delivered
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Brinkman, MD, MEd
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
12. IPD Sharing Statement
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Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
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