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OpenTrials
Completed

NCT Number: NCT00631280

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

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choice

Behavioral

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

Behavioral

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

  1. Number of days covered with medication as determined by pharmacy refill records

    Time frame: one year

Secondary outcomes

  1. Decisional Conflict

    Time frame: immediately after intervention or control condition delivered

  2. Decisional Regret

    Time frame: immediately after intervention or control condition delivered

  3. Satisfaction with Information about Medicine

    Time frame: immediately after intervention or control condition delivered

  4. Working Alliance Inventory

    Time frame: immediately after intervention or control condition delivered

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Response Variability in Children With ADHD

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Mar 7, 2008
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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