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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00429221
• Other study ID #: #5327
• Secondary ID: R34MH078700DAHBR
• Status: Withdrawn
• Phase: N/A
• First received: January 30, 2007
• Last updated: April 22, 2013
• Start date: January 2006

Study information

• Verified date: April 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• Tailored Medication Messages for Parents

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

References & Publications (6)

Achenbach TM, Howell CT, Quay HC, Conners CK. National survey of problems and competencies among four- to sixteen-year-olds: parents' reports for normative and clinical samples. Monogr Soc Res Child Dev. 1991;56(3):1-131. — View Citation

Dolezal C, Mellins C, Brackis-Cott E, Abrams EJ. The reliability of reports of medical adherence from children with HIV and their adult caregivers. J Pediatr Psychol. 2003 Jul-Aug;28(5):355-61. — View Citation

Hollingshead, A. B. (1975). Four factor index of social status. Unpublished manuscript, Yale University, NewHa ven, CT.

Mellins CA, Brackis-Cott E, Dolezal C, Abrams EJ. The role of psychosocial and family factors in adherence to antiretroviral treatment in human immunodeficiency virus-infected children. Pediatr Infect Dis J. 2004 Nov;23(11):1035-41. — View Citation

Rizzo JA, Simons WR. Variations in compliance among hypertensive patients by drug class: implications for health care costs. Clin Ther. 1997 Nov-Dec;19(6):1446-57; discussion 1424-5. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents' attitudes and beliefs
Primary	Parents' reported adherence, prescription refill, and side effect information
Primary	Children's adherence (all measured at Months 1, 3, and 6)