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Clinical Trials/NCT01967485
NCT01967485CompletedNot Applicable

Text Messaging Adherence to Stimulant Medication

Massachusetts General Hospital2 sites in 1 country35 target enrollmentStarted: January 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
2
Primary Endpoint
Medication Adherence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Medication Adherence

Time Frame: Six Months

Adherence to the individualized medication regimen

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mai Uchida

Child Psychiatrist, Pediatric Psychopharmacology and Adult ADHD Program, Massachusetts General Hospital; Instructor in Psychiatry, Harvard Medical School

Massachusetts General Hospital

Study Sites (2)

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