Text Messaging Adherence to Stimulant Medication

NCT ID: NCT01967485

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Text Messaging

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

Group Type EXPERIMENTAL

Text- Messaging

Intervention Type OTHER

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

Treatment as usual

Intervention Type OTHER

Children will receive stimulant treatment for ADHD.

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.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Children will receive stimulant treatment for ADHD.

Interventions

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Text- Messaging

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

Intervention Type OTHER

Treatment as usual

Children will receive stimulant treatment for ADHD.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Child Adolescent Psychiatry.

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mai Uchida

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mai Uchida, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2013-P-002161

Identifier Type: -

Identifier Source: org_study_id

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