NCT01967485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

October 18, 2013

Last Update Submit

February 22, 2017

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity DisorderMedication adherenceDisease managementText messageADHDChildrenReminder systemsText MessagingTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    Adherence to the individualized medication regimen

    Six Months

Study Arms (2)

Text Messaging

EXPERIMENTAL

Text messaging to the parents of children. Children will receive open treatment for Attention Deficit/Hyperactivity Disorder (ADHD) with stimulant medication.

Other: Text- MessagingOther: 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.

Other: Treatment as usual

Interventions

Text- MessagingOTHER

Text messages will be sent to the parents of children enrolled in the study.

Text Messaging
Treatment as usualOTHER

Children will receive stimulant treatment for ADHD.

No Text MessagingText Messaging

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMedication Adherence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Mai Uchida, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Child Psychiatrist, Pediatric Psychopharmacology and Adult ADHD Program, Massachusetts General Hospital; Instructor in Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 23, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)