Clinical trial NCT00429221: Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder
Official title: ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parents' attitudes and beliefs
measure: Parents' reported adherence, prescription refill, and side effect information
measure: Children's adherence (all measured at Months 1, 3, and 6)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University/New York State Psychiatric Institute
name: Elizabeth A. Pappadopulos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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