Attention Deficit Disorder With Hyperactivity Clinical Trial
Official title:
ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV
This three-phase study will develop and test a provider-administered intervention to improve medication adherence and promote sustained medication use among children with ADHD and their caregivers.
Attention deficit hyperactivity disorder (ADHD) is a common childhood behavior disorder that
causes impaired functioning in multiple settings, including home, school, and in
relationships with peers. Symptoms of ADHD include impulsiveness, hyperactivity, and
inattention. Both medications and behavior therapies have been shown to be effective in
treating ADHD. It is essential, however, that children take their medication regularly for
it to be effective. This three-phase study will develop and test a provider-administered
intervention to improve medication adherence and persistence among children with ADHD and
their caregivers.
The first phase of this study will gather information about perspectives on ADHD and its
treatment by using focus groups and interviews with participating children and their
parents. Phase two of the study will gather information on medication adherence and
persistence, as well as demographic information. Phase three of the study will involve
developing and testing a three part intervention consisting of an ADHD education component,
a short survey to help parents identify non-adherence warning signs, and tailored medication
messages for parents. After conducting a pilot with five parent-child pairs to assess
feasibility and accessibility, all interested doctors at the study site will receive a
lecture on evidence-based treatments for ADHD and a supply of parent ADHD education
toolkits. Half of the doctors will be randomly assigned to receive additional training on
the experimental procedures and to administer the intervention as part of the study. Parent
and child participants will be randomly assigned to receive either treatment with a doctor
who has been trained on the experimental intervention or treatment as usual. Assessments
will take place at the beginning of treatment and 1, 3, and 6 months after the start of
treatment. During each assessment, a saliva sample will be collected from the child, and
parents will complete several checklists and questionnaires about ADHD treatment and
medication adherence.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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