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Text Messaging Adherence to Stimulant Medication

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text- Messaging
Treatment as usual
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Medication adherence, Disease management, Text message, ADHD, Children, Reminder systems, Text Messaging, Telemedicine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Text Messaging

No Text Messaging

Arm Description

Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.

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.

Outcomes

Primary Outcome Measures

Medication Adherence
Adherence to the individualized medication regimen

Secondary Outcome Measures

Full Information

First Posted
October 18, 2013
Last Updated
February 22, 2017
Sponsor
Massachusetts General Hospital
Collaborators
American Academy of Child Adolescent Psychiatry.
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1. Study Identification

Unique Protocol Identification Number
NCT01967485
Brief Title
Text Messaging Adherence to Stimulant Medication
Official Title
Text Messaging Adherence to Stimulant Medication
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Academy of Child Adolescent Psychiatry.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Medication adherence, Disease management, Text message, ADHD, Children, Reminder systems, Text Messaging, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Messaging
Arm Type
Experimental
Arm Description
Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.
Arm Title
No Text Messaging
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Text- Messaging
Intervention Description
Text messages will be sent to the parents of children enrolled in the study.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Children will receive stimulant treatment for ADHD.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
Adherence to the individualized medication regimen
Time Frame
Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Uchida, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Text Messaging Adherence to Stimulant Medication

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