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

Study Overview
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Brief Summary
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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.

Official Title
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Response Variability in Children With ADHD

Conditions
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Attention-Deficit/Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Behavioral: Choice
* Behavioral: Recommendation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choice<br> | Behavioral: Choice<br>* 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.<br>|
| Active Comparator: Recommendation<br> | Behavioral: Recommendation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days covered with medication as determined by pharmacy refill records |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Aid, Informed Choice, Adherence