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

NCT ID: NCT00631280

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Choice

Group Type EXPERIMENTAL

Choice

Intervention Type BEHAVIORAL

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.

Recommendation

Group Type ACTIVE_COMPARATOR

Recommendation

Intervention Type BEHAVIORAL

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.

Interventions

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Choice

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.

Intervention Type BEHAVIORAL

Recommendation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Bill Brinkman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Brinkman, MD, MEd

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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5R01MH074770-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-12-16

Identifier Type: -

Identifier Source: org_study_id

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