Text Messaging Adherence to Stimulant Medication

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT01967485
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-23
• Study Start: 2014-01
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Male or female children ages 6-17 years
• A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment and supported by a Clinical Global Impression- ADHD (CGI-ADHD) Severity Score of at least 4 (Moderately Ill)
• Has a parent in possession of a cellular phone with text messaging capabilities and is interested in and willing to receive planned text messages
• Has never been treated with stimulant medication, or has begun treatment with stimulant medication within three months of study enrollment.

Exclusion Criteria

• Any serious, unstable, chronic medical condition, per clinician assessment
• Cardiovascular disease
• Current or past history of seizures
• Treatment with stimulant medication beyond three months prior to enrollment
• Pregnant or nursing females
• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
• Unstable psychiatric illness other than ADHD, including, but not limited to: Autism, Bipolar Disorder, Psychosis, Major Depressive Disorder, Anorexia, Bulimia, Post-Traumatic Stress Disorder and Anxiety Disorders
• History of multiple adverse drug reactions
• Presence of suicidal risk, or homicidality
• Unwilling/unable to comply with study procedures
• Poor command of the English language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Adherence	Six Months	Adherence to the individualized medication regimen

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States