Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375525
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2024-04-17
Brief Title:
Clinical Trial The Efficacy of Janssens Icon Application App in Improving Adherence to Treatment With Stimulant Medications in Children With Attention DeficitHyperactivity Disorder
Sponsor:
Prof Doron Gothelf MD
Organization:
Sheba Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
App ADHD
Brief Summary:
The overarching aim of the study is to assess the efficacy of Janssens icon Application App a digital tool designed to improve adherence to medication treatment in children with ADHD
Our specific hypotheses are
1 In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual ie not provided with the App tool
2 Adherent patients will show greater improvement of ADHD symptoms and related dysfunction
Our specific hypotheses are
1 In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual ie not provided with the App tool
2 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 patients 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
We believe that the poor adherence to stimulants treatment in children with ADHD can be improved if we develop intervention programs that focus on increasing adherence to drug treatment Yet to the best of our knowledge there are no studies on the efficacy of interventions geared towards improving adherence to medication treatment in children with ADHD
Objective The overarching aim of the study is to assess the efficacy of Janssens icon Application App a digital tool designed to improve adherence to medication treatment in children with ADHD
Our specific hypotheses are
1 In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual ie not provided with the App tool
2 Adherent patients will show greater improvement of ADHD symptoms and related dysfunction
Study Population The study will include 80 children aged 6-18 years with the diagnosis of ADHD according to the DSM-5 criteria that are already receiving medication treatment for ADHD with methylphenidate mixed amphetamine salts lisdexamfetamine or dexmethylphenidate
The patients will be consecutively recruited from the Child Psychiatry Unit and ADHD and Learning Disorders Clinic at Edmond Lili Safra Childrens Hospital Sheba Medical Center
Inclusion criteria
1 Diagnosis of ADHD based on the DSM-5
2 Age between 6 to 18 years
3 Eligible for receiving ADHD treatment with methylphenidate mixed amphetamine salts lisdexamfetamine or dexmethylphenidate
3 Parents own smart phone device 4 Parents will sign a consent form
Study Procedure Diagnostic interviews of children with ADHD and one or both caregivers will be conducted by a child and adolescent psychiatrist The study will be submitted to the Helsinki committee at the Sheba Medical Center
The 80 children with ADHD enrolled to this study will be randomized to 2 arms the study group n40 will be provided with the icon App and the control group n40 will not be provided the App The study and control groups will be matched for age gender distribution socioeconomic status and type of ADHD medication Our plan is to complete the recruitment of subjects within 6 months from study initiation
The design of the study is also summarized in the Figure and Table below For all patients an assessment of socio-demographic and clinical characteristics will be conducted at baseline time 0 by a child and adolescent psychiatrist using the Attention Module of the Kiddie-SADS 17 and the MINI-KID 18 to screen for symptoms of other comorbid disorders The ADHD-Rating Scale Questionnaire ADHD-RS 19 and the Clinical Global Impression Scale CGI 20 will be used to assess the severity of ADHD symptoms and clinical improvement A research assistant will guide and train the study group families on how to use the App At the end of months 1 2 and 3 the patients and their parents will visit the clinic or will be interviewed on the phone and will be assessed for adherence using the Medication Adherence Rating Scale MARS 21 and the Clinician Rating Scale CRS 22 In addition change in ADHD symptoms will be assessed using the ADHD-RS questionnaire and the CGI Side effects will be measured using the Barkley Side Effects Rating Scale Drug accountability will be recorded by the parent as a checkmark on a medication log which will be reviewed by the clinician during the study visits At the end of visit 3 after 2 month we will conduct a Parent Satisfaction Survey
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 patients 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
We believe that the poor adherence to stimulants treatment in children with ADHD can be improved if we develop intervention programs that focus on increasing adherence to drug treatment Yet to the best of our knowledge there are no studies on the efficacy of interventions geared towards improving adherence to medication treatment in children with ADHD
Objective The overarching aim of the study is to assess the efficacy of Janssens icon Application App a digital tool designed to improve adherence to medication treatment in children with ADHD
Our specific hypotheses are
1 In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual ie not provided with the App tool
2 Adherent patients will show greater improvement of ADHD symptoms and related dysfunction
Study Population The study will include 80 children aged 6-18 years with the diagnosis of ADHD according to the DSM-5 criteria that are already receiving medication treatment for ADHD with methylphenidate mixed amphetamine salts lisdexamfetamine or dexmethylphenidate
The patients will be consecutively recruited from the Child Psychiatry Unit and ADHD and Learning Disorders Clinic at Edmond Lili Safra Childrens Hospital Sheba Medical Center
Inclusion criteria
1 Diagnosis of ADHD based on the DSM-5
2 Age between 6 to 18 years
3 Eligible for receiving ADHD treatment with methylphenidate mixed amphetamine salts lisdexamfetamine or dexmethylphenidate
3 Parents own smart phone device 4 Parents will sign a consent form
Study Procedure Diagnostic interviews of children with ADHD and one or both caregivers will be conducted by a child and adolescent psychiatrist The study will be submitted to the Helsinki committee at the Sheba Medical Center
The 80 children with ADHD enrolled to this study will be randomized to 2 arms the study group n40 will be provided with the icon App and the control group n40 will not be provided the App The study and control groups will be matched for age gender distribution socioeconomic status and type of ADHD medication Our plan is to complete the recruitment of subjects within 6 months from study initiation
The design of the study is also summarized in the Figure and Table below For all patients an assessment of socio-demographic and clinical characteristics will be conducted at baseline time 0 by a child and adolescent psychiatrist using the Attention Module of the Kiddie-SADS 17 and the MINI-KID 18 to screen for symptoms of other comorbid disorders The ADHD-Rating Scale Questionnaire ADHD-RS 19 and the Clinical Global Impression Scale CGI 20 will be used to assess the severity of ADHD symptoms and clinical improvement A research assistant will guide and train the study group families on how to use the App At the end of months 1 2 and 3 the patients and their parents will visit the clinic or will be interviewed on the phone and will be assessed for adherence using the Medication Adherence Rating Scale MARS 21 and the Clinician Rating Scale CRS 22 In addition change in ADHD symptoms will be assessed using the ADHD-RS questionnaire and the CGI Side effects will be measured using the Barkley Side Effects Rating Scale Drug accountability will be recorded by the parent as a checkmark on a medication log which will be reviewed by the clinician during the study visits At the end of visit 3 after 2 month we will conduct a Parent Satisfaction Survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None