Text Messaging Adherence to Stimulant Medication

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: Text- Messaging; Other: Treatment as usual

• 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

Arm && Interventions

Group	Intervention	Description
Text Messaging	Text- Messaging	Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.
No Text Messaging	Treatment as usual	Children will receive open treatment for ADHD with stimulant medication. This group will not get the text messaging intervention, but will receive treatment as usual.
Text Messaging	Treatment as usual	Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.

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