Back to resultsA Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medications in Children With ADHD
Primary Purpose
Attention Deficit/Hyperactivity Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMS Intervention
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit/Hyperactivity Disorder focused on measuring Attention Deficit/Hyperactivity Disorder, ADHD, SMS Intervention
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMS Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04189562
First Posted
December 4, 2019
Last Updated
May 25, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04189562
Brief Title
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medications in Children With ADHD
Official Title
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medications in Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
Keywords
Attention Deficit/Hyperactivity Disorder, ADHD, SMS Intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMS Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SMS Intervention
Intervention Description
Delivery of text messages will use the text messaging program Simple Online Family Intervention for ADHD (SOFIA).
Primary Outcome Measure Information:
Title
Adherence to Stimulants
Description
Adherence will be analyzed using the timeliness of stimulant medication prescription renewals over the 9 month period as documented in the participants medical record.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Law, BA
Phone
617-724-2551
Email
claw3@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Driscoll, BA
Phone
617-724-2551
Email
hdriscoll2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medications in Children With ADHD
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