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

NCT ID: NCT00429221

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Tailored Medication Messages for Parents

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• 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

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:

• 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:

• 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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A. Pappadopulos, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University/New York State Psychiatric Institute

References

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Reference Type: BACKGROUND

PMID: 9444452 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12808012 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15545859 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 1770964 (View on PubMed)

Swanson J, Nolan R, Pelham W (1988): Swanson, Nolan and Pelham rating scale (SNAP). Pittsburgh, PA, Department of Psychiatry, Western Psychiatric Institute and Clinic.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Other Identifiers

R34MH078700

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 96-BHA

Identifier Type: -

Identifier Source: secondary_id

#5327

Identifier Type: -

Identifier Source: org_study_id