A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medications in Children With ADHD

May 25, 2022 updated by: Joseph Biederman, MD, Massachusetts General Hospital

This study will assess the efficacy of the text messaging (SMS-based) disease management intervention for children with Attention Deficit/Hyperactivity Disorder (ADHD) using the timeliness of stimulant prescription renewals over a 9-month period.

Parents of participants in the study will receive customized text messages once a day, Sunday through Friday, for a duration of 9 months. The text messages will include reminders to adhere to the individualized medication regimen, reminders to call their child's clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Joseph Biederman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 6-12 years of age of both sexes and their parent
  • A diagnosis of ICD-10 or DSM 5 diagnosis of Attention Deficit/Hyperactivity Disorder including the following ICD codes (F90 Attention-deficit hyperactivity disorders; F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type; F90.1 Attention- deficit hyperactivity disorder, predominantly hyperactive type; F90.2 Attention-deficit hyperactivity disorder, combined type;F90.8 Attention-deficit hyperactivity disorder, other type; F90.9 Attention-deficit hyperactivity disorder, unspecified type) and/or the following DSM 5 diagnoses (314.01, F90.2 Attention-deficit/hyperactivity disorder, combined presentation; 314.01, F90.1 Attention-deficit/hyperactivity disorder, predominantly hyperactive/impulsive presentation;314.00, F90.0 Attention- deficit/hyperactivity disorder, predominantly inattentive presentation)
  • Starting or currently on stimulant medication including (Amphetamine/Dextroamphetamine (Adderall);Dextroamphetamine (Dexedrine, ProCentra, Zenzedi, Adderall XR); Dexmethylphenidate (Focalin, Focalin XR); Methylphenidate (Ritalin, Ritalin SR, Metadate ER, Methylin ER, Concerta, Daytrana, Metadate CD, Quillivant XR, Ritalin LA); Amphetamine sulfate (Evekeo); Lisdexamfetamine (Vyvanse))
  • Proficient in English
  • Has a cellular phone with text messaging capabilities and is interested in and willing to receive free of charge text messages

Exclusion Criteria:

  • Investigator and his/her immediate family
  • Unwilling/unable to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SMS Intervention
All parents of participants will receive customized text messages once a day, Sunday through Friday, for a duration of 9 months that will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment.
Other: SMS Intervention
Delivery of text messages will use the text messaging program Simple Online Family Intervention for ADHD (SOFIA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Stimulants
Time Frame: 9 months
Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period as documented in the participants medical record.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2017

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (ACTUAL)

December 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-P-002715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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