Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder

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.

PHASE I:

Inclusion Criteria:

Parent Focus Group Participants:

- Must be primary caregiver and legal guardian of child (6-10 years) at time of initial
ADHD diagnosis

- Child must have been diagnosed with ADHD within the last 18 months at Schneider
Children’s Hospital's (SCH) outpatient clinic (co-morbid diagnosis of oppositional
defiant disorder [ODD] or conduct disorder [CD] is permitted)

Provider Focus Group Participants:

- Child psychiatrist employed by North Shore - Long Island Jewish child psychiatry
outpatient department

- Licensed to practice in New York State

- Has more than 1 year of experience prescribing medication to youth with ADHD

Child Interview Participants:

- Diagnosis of ADHD (co-morbid diagnosis of ODD, CD, or mood disorder is permitted)

- Between 6 and 10 years old at time of initial ADHD diagnosis

- Diagnosis occurred within 18 months prior to study entry at Zucker Hillside Hospital
outpatient clinic

Exclusion Criteria:

Parent Focus Group Participants and Child Interview Participants:

- Child has significant co-morbid medical conditions, such as diabetes, cystic
fibrosis, or severe asthma, resulting in more than 2 emergency visits in the last
year

- Child has a co-morbid diagnosis of psychosis, bipolar disorder, or other serious
psychiatric condition within 12 months prior to study entry

- Child has history of psychiatric hospitalization within 12 months prior to study
entry

- Child is receiving treatment in a different setting

PHASE II:

Inclusion Criteria:

- Primary caregiver and legal guardian of child (6-10 years) at the time of initial
ADHD diagnosis

- Child has been diagnosed with ADHD within the last 18 months at SCH's outpatient
clinic

Exclusion Criteria:

- Parents of children with co-morbid medical conditions other than oppositional defiant
disorder (ODD) or conduct disorder (CD)

- Parents of children with a co-morbid diagnosis of psychosis, bipolar disorder, mental
retardation, or other severe mental illness, evidence of mental retardation, or
history of psychiatric hospitalization within 12 months prior to study entry

- Child is receiving treatment in a different setting

PHASE III:

Inclusion Criteria:

- Medication naïve children with a primary diagnosis of ADHD (co-morbid ODD will be
permitted) at the Child Psychiatric Outpatient Department at SCH

- Parents are the legal guardians

- Both parents and children willing to sign the informed consent/assent

Exclusion Criteria:

- Children with co-morbid medical conditions other than ODD

- Children with a co-morbid diagnosis of psychosis, bipolar disorder, or other serious
psychiatric condition, evidence of mental retardation, or history of recent
hospitalization