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

March 3, 2015 updated by: Bill Brinkman, Children's Hospital Medical Center, Cincinnati

Response Variability in Children With ADHD

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choice
Behavioral: 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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: William Brinkman, MD, MEd, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-12-16
  • 5R01MH074770-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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