Overview

This trial is active, not recruiting.

Condition attention-deficit/hyperactivity disorder (adhd)
Treatments choice, recommendation
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator National Institute of Mental Health (NIMH)
Start date September 2007
End date September 2010
Trial size 71 participants
Trial identifier NCT00631280, 05-12-16, 5R01MH074770-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
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 Outcomes

Measure
Number of days covered with medication as determined by pharmacy refill records
time frame: one year

Secondary Outcomes

Measure
Decisional Conflict
time frame: immediately after intervention or control condition delivered
Decisional Regret
time frame: immediately after intervention or control condition delivered
Satisfaction with Information about Medicine
time frame: immediately after intervention or control condition delivered
Working Alliance Inventory
time frame: immediately after intervention or control condition delivered

Eligibility Criteria

Male or female participants from 7 years up to 11 years old.

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

Additional Information

Official title Response Variability in Children With ADHD
Principal investigator William Brinkman, MD, MEd
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.