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

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Response Variability in Children With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631280
• Other study ID #: 05-12-16
• Secondary ID: 5R01MH074770-02
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: March 3, 2015
• Start date: September 2007
• Est. completion date: September 2011

Study information

• Verified date: March 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder (ADHD)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days covered with medication as determined by pharmacy refill records		one year	No
Secondary	Decisional Conflict		immediately after intervention or control condition delivered	No
Secondary	Decisional Regret		immediately after intervention or control condition delivered	No
Secondary	Satisfaction with Information about Medicine		immediately after intervention or control condition delivered	No
Secondary	Working Alliance Inventory		immediately after intervention or control condition delivered	No