Attention Deficit Hyperactivity DisorderNCT01967485
Text Messaging Adherence to Stimulant Medication
A study testing Text- Messaging and Treatment as usual in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Text- Messaging and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children ages 6-17 years
- A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment and supported by a Clinical Global Impression- ADHD (CGI-ADHD) Severity Score of at least 4 (Moderately Ill)
- Has a parent in possession of a cellular phone with text messaging capabilities and is interested in and willing to receive planned text messages
- Has never been treated with stimulant medication, or has begun treatment with stimulant medication within three months of study enrollment.
Who cannot join
- Any serious, unstable, chronic medical condition, per clinician assessment
- Cardiovascular disease
- Current or past history of seizures
- Treatment with stimulant medication beyond three months prior to enrollment
- Pregnant or nursing females
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Show all 11Show fewer
- Unstable psychiatric illness other than ADHD, including, but not limited to: Autism, Bipolar Disorder, Psychosis, Major Depressive Disorder, Anorexia, Bulimia, Post-Traumatic Stress Disorder and Anxiety Disorders
- History of multiple adverse drug reactions
- Presence of suicidal risk, or homicidality
- Unwilling/unable to comply with study procedures
- Poor command of the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Text- Messaging, Treatment as usual
- Keywords
- Attention Deficit Hyperactivity Disorder, Medication adherence, Disease management, Text message, ADHD, Children, Reminder systems, Text Messaging, Telemedicine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text- MessagingOther
Text messages will be sent to the parents of children enrolled in the study.
Treatment as usualOther
Children will receive stimulant treatment for ADHD.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging | Experimental | Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication. Receives: Other: Text- Messaging; Other: Treatment as usual |
| No Text Messaging | Active comparator | Children will receive open treatment for ADHD with stimulant medication. This group will not get the text messaging intervention, but will receive treatment as usual. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Adherence to the individualized medication regimen
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Responsible party
- Principal investigator, Mai Uchida, Massachusetts General Hospital
- Investigators
- Mai Uchida, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967485
- Sponsor's protocol ID
- 2013-P-002161
- Status last verified
- Feb 2017
- First submitted
- 18 Oct 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging Adherence to Stimulant Medication
- ClinicalTrials.gov ID
- NCT01967485
- Acronym / sponsor ID
- 2013-P-002161
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Medication adherence, Disease management, Text message, ADHD, Children, Reminder systems, Text Messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Academy of Child Adolescent Psychiatry.
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Messaging | Experimental | Other: Text- Messaging, Other: Treatment as usualText messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication. |
| No Text Messaging | Active comparator | Other: Treatment as usualChildren will receive open treatment for ADHD with stimulant medication. This group will not get the text messaging intervention, but will receive treatment as usual. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female children ages 6-17 years
- A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment and supported by a Clinical Global Impression- ADHD (CGI-ADHD) Severity Score of at least 4 (Moderately Ill)
- Has a parent in possession of a cellular phone with text messaging capabilities and is interested in and willing to receive planned text messages
- Has never been treated with stimulant medication, or has begun treatment with stimulant medication within three months of study enrollment.
Key exclusion criteria (11 listed)
- Any serious, unstable, chronic medical condition, per clinician assessment
- Cardiovascular disease
- Current or past history of seizures
- Treatment with stimulant medication beyond three months prior to enrollment
- Pregnant or nursing females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text- MessagingText messages will be sent to the parents of children enrolled in the study. | Other | Text Messaging |
| Treatment as usualChildren will receive stimulant treatment for ADHD. | Other | No Text Messaging, Text Messaging |
Primary outcome
Medication Adherence
Time frame: Six Months
Adherence to the individualized medication regimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Uchida, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text- Messaging and Treatment as usual in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017; AzTrials last refreshed its copy on 28 Oct 2026.