Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder
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ClinicalTrials.gov Identifier: NCT00429221 |
Recruitment Status
:
Withdrawn
First Posted
: January 31, 2007
Last Update Posted
: April 23, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attention Deficit Disorder With Hyperactivity | Behavioral: Tailored Medication Messages for Parents | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV |
Study Start Date : | January 2006 |

- Parents' attitudes and beliefs
- Parents' reported adherence, prescription refill, and side effect information
- Children's adherence (all measured at Months 1, 3, and 6)

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429221
Principal Investigator: | Elizabeth A. Pappadopulos, PhD | Columbia University/New York State Psychiatric Institute |
Publications:
Responsible Party: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00429221 History of Changes |
Other Study ID Numbers: |
#5327 R34MH078700 ( U.S. NIH Grant/Contract ) DAHBR 96-BHA |
First Posted: | January 31, 2007 Key Record Dates |
Last Update Posted: | April 23, 2013 |
Last Verified: | April 2013 |
Keywords provided by New York State Psychiatric Institute:
ADHD |
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |