Clinical Trial: The Efficacy of Janssen's Icon Application (App) in Improving Adherence to Treatment With Stimulant Medications in Children With Attention Deficit/Hyperactivity Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Attention Module of the Kiddie-SADS questionniare
Study Overview
Brief Summary
The overarching aim of the study is to assess the efficacy of Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.
Our specific hypotheses are:
- In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual (i.e., not provided with the App tool).
- Adherent patients will show greater improvement of ADHD symptoms and related dysfunction.
Detailed Description
Background and Rationale ADHD is one of the most common neurobehavioral disorders of childhood that affects approximately 6-10% of school-age children and is associated with significant impairment of cognitive and psychosocial functioning (1-3).
Psychostimulant medications are the most effective treatment for ADHD (4). Methylphenidate (MPH) is the drug of choice in Israel for children, adolescents and adults with ADHD and amphetamine derivatives are used when response to MPH is insufficient or when MPH is not tolerable (5).
Without adherence to treatment even the best medication will be ineffective. Adherence is defined as the extent to which a patient's actions correspond to the treatment recommendations of health care providers (6). The literature shows that adherence rates are lower for children as compared to adults, and for psychiatric patients as compared to medical patients (7). As a result, children with psychiatric disorders, such as ADHD, are at great risk for poor medication adherence.
Because of the long-term nature of the treatment, poor adherence turns out to be a crucial issue in ADHD treatment (8). Rates of stimulant adherence in children with ADHD vary considerably across studies but are generally stunningly low. For example, a large community study of urban elementary school children in the Philadelphia area found that only one in five of ADHD children treated with MPH adhered to the treatment (9).
Studies on adherence in children with ADHD suggest that predictors of poor adherence may include older age (10, 11), male gender (12), lower intelligence (12, 13), oppositional-defiant symptoms (13), lower socioeconomic status (14), three-times-daily regimen (10) and the presence of fewer symptoms of ADHD (15). Those who are adherent to their stimulant treatment are more likely to have more severe symptoms (11), high level of knowledge about ADHD, frequent clinical evaluation (16) and lack of proper family support (8).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Diagnosis of ADHD based on the DSM-5;
- •Age between 6 to 18 years
- •Eligible for receiving ADHD treatment with methylphenidate, mixed amphetamine salts, lisdexamfetamine or dexmethylphenidate
- •Parents own smart phone device.
- •Parents will sign a consent form
Exclusion Criteria
- Not provided
Arms & Interventions
Application (App), a digital tool
Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.
Intervention: Janssen's icon Application (App) (Device)
Outcomes
Primary Outcomes
Attention Module of the Kiddie-SADS questionniare
Time Frame: 3 time points: baseline, after 1 month, 3 month after baseline
Secondary Outcomes
- MINI-KID(3 time points: baseline, after 1 month, 3 month after baseline)
Investigators
Prof. Doron Gothelf MD
Director of Child and Adolescent Psychiatry Unit
Sheba Medical Center