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OpenTrials
Completed

NCT Number: NCT01967485

Text Messaging Adherence to Stimulant Medication

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text- Messaging

Other

Text messages will be sent to the parents of children enrolled in the study.

Treatment as Usual

Other

Children will receive stimulant treatment for ADHD.

Primary outcomes

  1. Medication Adherence

    Time frame: Six Months

    Adherence to the individualized medication regimen

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Academy of Child Adolescent Psychiatry.

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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