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
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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