Text Messaging Adherence to Stimulant Medication

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Text Messaging Adherence to Stimulant Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967485
• Other study ID #: 2013-P-002161
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: February 22, 2017
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Other:
• Text- Messaging
Text messages will be sent to the parents of children enrolled in the study.
• Treatment as usual
Children will receive stimulant treatment for ADHD.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Academy of Child Adolescent Psychiatry.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Adherence to the individualized medication regimen	Six Months