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

NCT ID: NCT04189562

Last Updated: 2022-05-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-22

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Attention Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMS Intervention

Intervention Type OTHER

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

Interventions

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SMS Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph Biederman, MD

Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cecilia Law, BA

Role: CONTACT

617-724-2551

Facility Contacts

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Haley Driscoll, BA

Role: primary

617-724-2551

Other Identifiers

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2016-P-002715

Identifier Type: -

Identifier Source: org_study_id

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