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

Not Applicable

• Conditions: Attention Deficit/Hyperactivity Disorder

• Registration Number: NCT04189562
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-22
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26
• Primary Completion: 2023-02
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence to Stimulants	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States