Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648538
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Evaluation of a Therapeutic Education Application in the Treatment of Young People with Moderate or Problematic Screen Use
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation Dune Application Déducation Thérapeutique Dans La Prise En Charge De Jeunes Ayant Un Usage Modéré Ou Problématique Des Écrans
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHONIX CARE
Brief Summary:
This single-center controlled and randomized study evaluates the effectiveness of the Phonix Care app in regulating screen use among young people aged 11 to 25 Faced with high and often concerning levels of screen consumption among youth this research aims to provide an innovative intervention method beyond current psychotherapeutic and pharmacological approaches which are often limited by the risk of relapse and the difficulty in delaying the short-term rewards offered by screen activities 1 2 3 Phonix Care is designed to encourage awareness and self-regulation of screen use thus promoting more responsible and autonomous behavior
The primary outcome measure is based on a problematic screen use score derived from the Digital Addiction Scale Secondary objectives include examining the effects of the app on screen consumption physical health mental health and motivation towards studies measured through a series of questionnaires and objective evaluations
The study is conducted on 138 subjects divided into two groups an experimental group and a control group over a participation period of six months Statistical analyses will include descriptive analyses multiple linear regression and mediation models to assess the impact of Phonix Care
The expected outcomes of this research include significant contributions to the scientific literature regarding screen use among youth as well as advances in adolescent and young adult health and psychology In practice the evaluation of Phonix Care could lead to the development of an effective medical device to quantify and treat problematic screen use offering a complementary therapy to existing methods to prevent or remedy this issue
1 Winkler A Dörsing B Rief W Shen Y Glombiewski JA Treatment of Internet addiction A meta-analysis Clinical Psychology Review 2013332317-29 httpsdoiorg101016jcpr201212005
2 Xu LX Wu LL Geng XM Wang ZL Guo XY Song KR Liu GQ Deng LY Zhang JT Potenza MN A review of psychological interventions for Internet addiction Psychiatry Research 2021302 114016 httpsdoiorg101016jpsychres2021114016
3 Zajac K Ginley MK Chang R Petry NM Treatments for Internet gaming disorder and Internet addiction A systematic review Psychology of Addictive Behaviors 2017318979-94 httpsdoiorg101037adb0000315
The primary outcome measure is based on a problematic screen use score derived from the Digital Addiction Scale Secondary objectives include examining the effects of the app on screen consumption physical health mental health and motivation towards studies measured through a series of questionnaires and objective evaluations
The study is conducted on 138 subjects divided into two groups an experimental group and a control group over a participation period of six months Statistical analyses will include descriptive analyses multiple linear regression and mediation models to assess the impact of Phonix Care
The expected outcomes of this research include significant contributions to the scientific literature regarding screen use among youth as well as advances in adolescent and young adult health and psychology In practice the evaluation of Phonix Care could lead to the development of an effective medical device to quantify and treat problematic screen use offering a complementary therapy to existing methods to prevent or remedy this issue
1 Winkler A Dörsing B Rief W Shen Y Glombiewski JA Treatment of Internet addiction A meta-analysis Clinical Psychology Review 2013332317-29 httpsdoiorg101016jcpr201212005
2 Xu LX Wu LL Geng XM Wang ZL Guo XY Song KR Liu GQ Deng LY Zhang JT Potenza MN A review of psychological interventions for Internet addiction Psychiatry Research 2021302 114016 httpsdoiorg101016jpsychres2021114016
3 Zajac K Ginley MK Chang R Petry NM Treatments for Internet gaming disorder and Internet addiction A systematic review Psychology of Addictive Behaviors 2017318979-94 httpsdoiorg101037adb0000315
Detailed Description:
Quality assurance A risk analysis of our application was conducted by an external organization Surgiqual Institute Their audit validated that our cybersecurity systems and risk management procedures were state-of-the-art in compliance with medical legislation applicable to our application They produced a document to state that based on their audit they affirm the responsibility for ensuring the technical and legislative compliance of our application
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Data checks each data type had to match with a user profile template JSON FORMAT
unique_encrypted_code_name characters AND number
usage_data characters
date characters DD-MM-YY
screen_type characters
app_name characters
usage_data_per_app usage_value number
questionnaire_data characters
date characters DD-MM-YY
questionnaire_name characters
questionnaire_item questionnaire_response number
additional_personal_data characters
Source data verification a preliminary technical study with 15 participants was conducted to
Validate that the self-reported hourly screen usage in the technical study corresponded to the data passively collected by our telemetric measurement applications over one month
Confirm that the self-reported responses to online questionnaires matched the actual answers provided by the participants
Ensure that each participants key could be used only once
Verify that participants assigned to the experimental group couldnt bypass the applications restrictions
Data dictionary
Daily application usage data Source application Phonix Care
First opening schedule
Last opening schedule
Opening Frequency
Usage duration
Questionnaires responses Source the participant through the application Phonix Care
o Digital Addiction Scale
Regulation of Screen Time Consumption
International Physical Activity Questionnaire
Sleep Schedules diary
Revised Screen for Child Anxiety Related Emotional Disorders SCARED-R
University of Laval Loneliness Scale ULS
Rosenberg Self-Esteem Scale
Education Motivation Scale EMS
Experimental arm only specific screen rules during the 5-months intervention period and the number of challenges that were completed
Standard Operating Procedures SOPs were split into 10 steps
1 Patient Recruitment
Patient recruitment procedures will be conducted in accordance with the study protocol
Recruitment efforts will be documented and tracked using electronic records maintained within the clinical trial management system CTMS
2 Data Collection
Data collection will be performed using the Phonix Care application for daily application usage data
Participants will input responses to questionnaires directly into the Phonix Care application
For participants in the experimental arm specific screen rules adherence and challenge completion will be recorded within the Phonix Care application
3 Data Management
Data collected from the Phonix Care application will be securely transmitted and stored on a dedicated health server hosted by a certified data management provider AZNETWORK
Access to the data will be restricted to authorized personnel only with appropriate user permissions assigned based on roles and responsibilities
Pseudo-anonymization procedures will be implemented to protect participant confidentiality
Regular data backups will be performed to ensure data integrity and availability
4 Data Analysis
Data analysis will be conducted using statistical software approved by the study investigators notably R SPSS and Python
Analysis will include aggregating daily application usage data questionnaire responses and experimental arm-specific data to assess intervention efficacy and participant outcomes
5 Reporting for Adverse Events
Any adverse events reported by participants will be documented in a dedicated electronic data capture system
Adverse events will be promptly reviewed by the study investigators and reported to the appropriate regulatory authorities as per regulatory requirements
6 Change Management
Any modifications to the study protocol or data management procedures will be documented and approved by the study sponsor and ethics committee
Changes will be communicated to relevant study personnel and updated procedures will be implemented accordingly
7 Quality Assurance
Regular quality checks will be conducted to ensure data accuracy and consistency
Data validation checks will be performed to identify any discrepancies or anomalies in the collected data
Internal audits will be conducted periodically to review data management procedures and compliance with SOPs
8 Training and Compliance
Study personnel involved in data collection and management will receive training on SOPs and data handling procedures
Compliance with SOPs will be monitored and enforced throughout the duration of the study
9 Record Keeping
All study-related documentation including SOPs data management logs and training records will be maintained in a secure electronic repository and duplicated to a secured space into a specific room of the AGEIS laboratory
Records will be retained in accordance with regulatory requirements and study protocol specifications
10 Documentation and Archiving
Upon study completion all study documentation will be archived for future reference and audit purposes
Archiving procedures will adhere to regulatory guidelines and institutional policies
Sample size assessment To evaluate the effectiveness of Phonix Care using the overall score from the Digital Addiction Scale by Hawi et al 2019 with an average Cohens effect size d 030 to 040 and a standard deviation of 1925 mean 563 here are the necessary sample sizes for different statistical powers 1-β with a significance level of α 005
80 power from 96 to 174 participants required 85 power from 110 to 200 participants required 90 power from 129 to 233 participants required
------------------------------------------------------------------------------------------------------------------------------------
Plan for missing data We conduct an analysis of the missing data mechanism according to the rules set by Little and Rubin Although it is very rare if we validate the hypothesis that the missing data are completely random Missing Completely At Random we conduct the analyses using the incomplete data set This data set will not bias the estimates The most likely case is the validation of the Missing At Random hypothesis which suggests that the missing data are due to one or more factors in our possession eg experimental condition threshold of problematic use we proceed with multiple imputations before conducting our analyses To determine if certain factors can explain whether the data are missing or not we use logistic regression analyses via the GLM package on R Studio version 402 In the case of multiple imputations we use the MICE package on R Studio version 402
------------------------------------------------------------------------------------------------------------------------------------
Statistical analysis plan We first proceed with the descriptive analysis of screen usage profiles and the number of profiles observed in our sample We expect to observe at least three usage profiles moderate intensive and problematic To do this we use the K-means clustering method Next the variables measured by questionnaire undergo longitudinal confirmatory factor analyses to ensure that despite experimentation we observe some longitudinal invariance of the measurement constructs ie weak invariance For our primary research objective we conduct analyses using multiple linear regression By controlling for certain factors that may have an effect on problematic screen usage eg gender age we evaluate the simple effects of digital addiction scores before the study and the assignment group and then the interaction effect between this addiction score and the assignment group on digital addiction scores at the end of the study To address our secondary objectives we conduct multiple linear regression and mediation analyses for each of the secondary objective variables as dependent variables in linear regressions and as mediation variables
------------------------------------------------------------------------------------------------------------------------------------
Data checks each data type had to match with a user profile template JSON FORMAT
unique_encrypted_code_name characters AND number
usage_data characters
date characters DD-MM-YY
screen_type characters
app_name characters
usage_data_per_app usage_value number
questionnaire_data characters
date characters DD-MM-YY
questionnaire_name characters
questionnaire_item questionnaire_response number
additional_personal_data characters
Source data verification a preliminary technical study with 15 participants was conducted to
Validate that the self-reported hourly screen usage in the technical study corresponded to the data passively collected by our telemetric measurement applications over one month
Confirm that the self-reported responses to online questionnaires matched the actual answers provided by the participants
Ensure that each participants key could be used only once
Verify that participants assigned to the experimental group couldnt bypass the applications restrictions
Data dictionary
Daily application usage data Source application Phonix Care
First opening schedule
Last opening schedule
Opening Frequency
Usage duration
Questionnaires responses Source the participant through the application Phonix Care
o Digital Addiction Scale
Regulation of Screen Time Consumption
International Physical Activity Questionnaire
Sleep Schedules diary
Revised Screen for Child Anxiety Related Emotional Disorders SCARED-R
University of Laval Loneliness Scale ULS
Rosenberg Self-Esteem Scale
Education Motivation Scale EMS
Experimental arm only specific screen rules during the 5-months intervention period and the number of challenges that were completed
Standard Operating Procedures SOPs were split into 10 steps
1 Patient Recruitment
Patient recruitment procedures will be conducted in accordance with the study protocol
Recruitment efforts will be documented and tracked using electronic records maintained within the clinical trial management system CTMS
2 Data Collection
Data collection will be performed using the Phonix Care application for daily application usage data
Participants will input responses to questionnaires directly into the Phonix Care application
For participants in the experimental arm specific screen rules adherence and challenge completion will be recorded within the Phonix Care application
3 Data Management
Data collected from the Phonix Care application will be securely transmitted and stored on a dedicated health server hosted by a certified data management provider AZNETWORK
Access to the data will be restricted to authorized personnel only with appropriate user permissions assigned based on roles and responsibilities
Pseudo-anonymization procedures will be implemented to protect participant confidentiality
Regular data backups will be performed to ensure data integrity and availability
4 Data Analysis
Data analysis will be conducted using statistical software approved by the study investigators notably R SPSS and Python
Analysis will include aggregating daily application usage data questionnaire responses and experimental arm-specific data to assess intervention efficacy and participant outcomes
5 Reporting for Adverse Events
Any adverse events reported by participants will be documented in a dedicated electronic data capture system
Adverse events will be promptly reviewed by the study investigators and reported to the appropriate regulatory authorities as per regulatory requirements
6 Change Management
Any modifications to the study protocol or data management procedures will be documented and approved by the study sponsor and ethics committee
Changes will be communicated to relevant study personnel and updated procedures will be implemented accordingly
7 Quality Assurance
Regular quality checks will be conducted to ensure data accuracy and consistency
Data validation checks will be performed to identify any discrepancies or anomalies in the collected data
Internal audits will be conducted periodically to review data management procedures and compliance with SOPs
8 Training and Compliance
Study personnel involved in data collection and management will receive training on SOPs and data handling procedures
Compliance with SOPs will be monitored and enforced throughout the duration of the study
9 Record Keeping
All study-related documentation including SOPs data management logs and training records will be maintained in a secure electronic repository and duplicated to a secured space into a specific room of the AGEIS laboratory
Records will be retained in accordance with regulatory requirements and study protocol specifications
10 Documentation and Archiving
Upon study completion all study documentation will be archived for future reference and audit purposes
Archiving procedures will adhere to regulatory guidelines and institutional policies
Sample size assessment To evaluate the effectiveness of Phonix Care using the overall score from the Digital Addiction Scale by Hawi et al 2019 with an average Cohens effect size d 030 to 040 and a standard deviation of 1925 mean 563 here are the necessary sample sizes for different statistical powers 1-β with a significance level of α 005
80 power from 96 to 174 participants required 85 power from 110 to 200 participants required 90 power from 129 to 233 participants required
------------------------------------------------------------------------------------------------------------------------------------
Plan for missing data We conduct an analysis of the missing data mechanism according to the rules set by Little and Rubin Although it is very rare if we validate the hypothesis that the missing data are completely random Missing Completely At Random we conduct the analyses using the incomplete data set This data set will not bias the estimates The most likely case is the validation of the Missing At Random hypothesis which suggests that the missing data are due to one or more factors in our possession eg experimental condition threshold of problematic use we proceed with multiple imputations before conducting our analyses To determine if certain factors can explain whether the data are missing or not we use logistic regression analyses via the GLM package on R Studio version 402 In the case of multiple imputations we use the MICE package on R Studio version 402
------------------------------------------------------------------------------------------------------------------------------------
Statistical analysis plan We first proceed with the descriptive analysis of screen usage profiles and the number of profiles observed in our sample We expect to observe at least three usage profiles moderate intensive and problematic To do this we use the K-means clustering method Next the variables measured by questionnaire undergo longitudinal confirmatory factor analyses to ensure that despite experimentation we observe some longitudinal invariance of the measurement constructs ie weak invariance For our primary research objective we conduct analyses using multiple linear regression By controlling for certain factors that may have an effect on problematic screen usage eg gender age we evaluate the simple effects of digital addiction scores before the study and the assignment group and then the interaction effect between this addiction score and the assignment group on digital addiction scores at the end of the study To address our secondary objectives we conduct multiple linear regression and mediation analyses for each of the secondary objective variables as dependent variables in linear regressions and as mediation variables
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