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Text Messaging Adherence to Stimulant Medication

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ClinicalTrials.gov Identifier: NCT01967485
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Mai Uchida, 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: Text- Messaging Other: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Text Messaging Adherence to Stimulant Medication
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Text Messaging
Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.
Other: Text- Messaging
Text messages will be sent to the parents of children enrolled in the study.

Other: Treatment as usual
Children will receive stimulant treatment for ADHD.

Active Comparator: No Text Messaging
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.
Other: Treatment as usual
Children will receive stimulant treatment for ADHD.




Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: Six Months ]
    Adherence to the individualized medication regimen



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967485


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Academy of Child Adolescent Psychiatry.
Investigators
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Principal Investigator: Mai Uchida, MD Massachusetts General Hospital

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Responsible Party: Mai Uchida, Child Psychiatrist, Pediatric Psychopharmacology and Adult ADHD Program, Massachusetts General Hospital; Instructor in Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01967485     History of Changes
Other Study ID Numbers: 2013-P-002161
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mai Uchida, Massachusetts General Hospital:
Attention Deficit Hyperactivity Disorder
Medication adherence
Disease management
Text message
ADHD
Children
Reminder systems
Text Messaging
Telemedicine

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs