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Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD

Response Variability in Children With ADHD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00631280
Enrollment
70
Registered
2008-03-07
Start date
2007-09-30
Completion date
2011-09-30
Last updated
2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

Decision Aid, Informed Choice, Adherence

Brief summary

The purpose of the study is to determine whether active parent involvement in deliberation and choice improves subsequent medication persistence for their child with ADHD.

Interventions

BEHAVIORALChoice

Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a decision aid. Parent treatment preferences will be elicited and parents will receive coaching in deliberation about striking a balance between benefit and tolerable side effects. Parent will then choose the week that was best for their child and plan their next steps. Parents will also receive a consultation report that contains a physician dosage recommendation.

BEHAVIORALRecommendation

Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a consultation report that also contains a physician dosage recommendation.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with ADHD based on DSM-IV criteria * Enrolled in school-setting * No learning disability * No past use of psychoactive medication

Exclusion criteria

* Do not meet DSM-IV criteria for ADHD * Not enrolled in school-setting * Presence of learning disability * History of brain injury * Past use of psychoactive medication

Design outcomes

Primary

MeasureTime frame
Number of days covered with medication as determined by pharmacy refill recordsone year

Secondary

MeasureTime frame
Decisional Conflictimmediately after intervention or control condition delivered
Decisional Regretimmediately after intervention or control condition delivered
Satisfaction with Information about Medicineimmediately after intervention or control condition delivered
Working Alliance Inventoryimmediately after intervention or control condition delivered

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026