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

NCT04189562 | Unknown

• 1 other identifier: 2016-P-002715
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit/Hyperactivity Disorder; ADHD; SMS Intervention

Outcome Measures

Primary Outcomes (1)

• Adherence to Stimulants

  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

Study Arms (1)

SMS Intervention

EXPERIMENTAL

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

Interventions

SMS Intervention OTHER

Delivery of text messages will use the text messaging program Simple Online Family Intervention for ADHD (SOFIA).

SMS Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Cecilia Law, BA

CONTACT

617-724-2551; claw3@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: February 22, 2017
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)