Attention Deficit Disorder With HyperactivityNCT00429221
Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder
A study testing Tailored Medication Messages for Parents in people with Attention Deficit Disorder With Hyperactivity, run by New York State Psychiatric Institute.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Tailored Medication Messages for Parents
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
About this study
Official title: ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV
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.
Read the 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.
- Being tested
- Tailored Medication Messages for Parents
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Medication Messages for ParentsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' attitudes and beliefs
Parents' reported adherence, prescription refill, and side effect information
Children's adherence (all measured at Months 1, 3, and 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth A. Pappadopulos, PhD, Principal investigator, Columbia University/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429221
- Sponsor's protocol ID
- #5327
- Other IDs
- R34MH078700, DAHBR 96-BHA
- Status last verified
- Apr 2013
- First submitted
- 30 Jan 2007
- Last updated
- 23 Apr 2013
- Results posted
- No
Publications
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. doi: 10.1016/s0149-2918(97)80018-5.
PubMed 9444452Dolezal 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. doi: 10.1093/jpepsy/jsg025.
PubMed 12808012Mellins 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. doi: 10.1097/01.inf.0000143646.15240.ac.
PubMed 15545859Achenbach 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.
PubMed 1770964Swanson J, Nolan R, Pelham W (1988): Swanson, Nolan and Pelham rating scale (SNAP). Pittsburgh, PA, Department of Psychiatry, Western Psychiatric Institute and Clinic.
Hollingshead, A. B. (1975). Four factor index of social status. Unpublished manuscript, Yale University, NewHa ven, CT.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHD Medication Adherence: A Parent-Provider Intervention Modeled From HIV
- ClinicalTrials.gov ID
- NCT00429221
- Acronym / sponsor ID
- #5327
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2006
- First posted
- 31 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
- 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
Key exclusion criteria (12 listed)
- 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
- Parents of children with co-morbid medical conditions other than oppositional defiant disorder (ODD) or conduct disorder (CD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Medication Messages for Parents | Behavioural | – |
Primary outcome
Parents' attitudes and beliefs
Parents' reported adherence, prescription refill, and side effect information
Children's adherence (all measured at Months 1, 3, and 6)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Background: PubMed 9444452Rizzo 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. doi: 10.1016/s0149-2918(97)80018-5.
- Background: PubMed 12808012Dolezal 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. doi: 10.1093/jpepsy/jsg025.
- Background: PubMed 15545859Mellins 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. doi: 10.1097/01.inf.0000143646.15240.ac.
- Background: PubMed 1770964Achenbach 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.
- BackgroundSwanson J, Nolan R, Pelham W (1988): Swanson, Nolan and Pelham rating scale (SNAP). Pittsburgh, PA, Department of Psychiatry, Western Psychiatric Institute and Clinic.
- BackgroundHollingshead, A. B. (1975). Four factor index of social status. Unpublished manuscript, Yale University, NewHa ven, CT.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Pappadopulos, PhD principal investigator
Columbia University/New York State Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Medication Messages for Parents in people with Attention Deficit Disorder With Hyperactivity, run by New York State Psychiatric Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' attitudes and beliefs. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00429221, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.